To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla ReconstructionNCT05207696
Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla Reconstruction
An observational study of To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction and To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Aim: To evaluate the efficacy of platelet-rich fibrin (PRF) or connective tissue graft (CTG) in papilla reconstruction (PR) with semilunar incision (SI) technique. Materials and Methods: A total of 55 sites (27 CTG and 28 PRF) from 20 patients who underwent PR with either PRF or CTG placed with SI in the maxillary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction, To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction
- What is being tested?
- retrospective data analysis
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2018to 18 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In Hacettepe University Periodontology Department (Jun 2016-Feb 2018), 186 patients treated with PR were scanned and the data of 55 sites (27 CTG and 28 PRF) from 20 patients meeting the criteria were included.
Who may be able to join
- All selected patients had consent for using their data.
- The data of the patients who underwent PR surgery by one of the authors (S.O.B.) using SI with either PRF or CTG in the maxillary anterior teeth having contact points,
- at least 2 mm keratinized tissue width (KTW) with probing depth (PD)≤ 3 mm adjacent to the open embrasure were included.
- It was ensured that all baseline (BL) and follow-up data were available and all patients received a comprehensive phase I periodontal treatment prior to the PR procedure.
Who cannot join
- the patients with systemic problems,
- having medications known to influence the periodontium
- Using tobacco/alcohol
- The relevant regions did not have endodontic problems/needs, caries and history of periodontal surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Dentistry, Periodontology Department
Ankara, Sıhhiye, 06230
About this study
Official title: Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla Reconstruction: A Retrospective Trial
Aim: To evaluate the efficacy of platelet-rich fibrin (PRF) or connective tissue graft (CTG) in papilla reconstruction (PR) with semilunar incision (SI) technique.
Materials and Methods: A total of 55 sites (27 CTG and 28 PRF) from 20 patients who underwent PR with either PRF or CTG placed with SI in the maxillary anterior region were included in the study. Baseline (BL) and follow-up (T1( first month), T3 (third month), T6 (sixth month)) clinical data including periodontal evaluations (gingival index (GI), plaque index (PI), papillary bleeding index, pocket depth (PD), keratinized tissue width (KTW), gingival recession), papilla-associated recordings (alveolar crest-interdental contact point (AC-IC), alveolar crest-papilla tip (AC-PT), papilla tip-interdental contact point (PT-IC), papilla height loss (PHL), interdental tissue stroke (ITS) and papilla presence index (PPI)) and patient satisfaction were analyzed.
Read the detailed description
PT-IC was taken as the primary outcome measure. Normal distribution was assessed by histogram and Shapiro-Wilk test. Continuous variables were represented as mean±SD whereas the categorical variables were reported as numbers and percentages. Chi-square test was used for the comparison of the categorical variables. Since the data was normally distributed, Friedman test was used to analyze the time-dependent changes in both groups and the inter-group comparisons were made with Mann-Whitney test. Generalized Estimating Equation was used for analyzing qualitative and quantitative data, time-dependent changes, and the difference between two methods. Data analysis was performed in IBM SPSS Statistics Version 23, and p<0.05 was considered as a significance threshold.
- Conditions
- To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction, To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction
- Being tested
- retrospective data analysis
- Keywords
- connective tissue graft, papilla reconstruction, platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data analysisOther
The data of the patients who underwent papilla reconstruction surgery by one of the authors (S.O.B.) using semilunar incision with either PRF or CTG in the maxillary anterior teeth were included in the study. All selected patients had consent for using their data.The data of the patients included in the study were analyzed.(Baseline (BL) and follow-up (T1( first month) , T3 (third month), T6 (sixth month)) clinical data including periodontal evaluations (gingival index (GI), plaque index (PI), papillary bleeding index, pocket depth (PD), keratinized tissue width (KTW), gingival recession), papilla-associated recordings (alveolar crest-interdental contact point (AC-IC), alveolar crest-papilla tip (AC-PT), papilla tip-interdental contact point (PT-IC), papilla height loss (PHL), interdental tissue stroke (ITS) and papilla presence index (PPI)) and patient satisfaction were analyzed.)
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich fibrin (PRF) | A total of 28 sites from 12 patients who underwent papilla reconstruction with PRF placed with semilunar incision in the maxillary anterior region were included in PRF group. ( Data of 12 patients were included in the study.) Receives: Other: retrospective data analysis | |
| Connective tissue graft (CTG) | A total of 27 sites from 8 patients who underwent papilla reconstruction with CTG placed with semilunar incision in the maxillary anterior region were included in CTG group. (Data of 8 patients were included in the study.) Receives: Other: retrospective data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar crest-Interdental contact point (AC-IC mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Measured: baseline
Alveolar crest-Interdental contact point (AC-IC mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Measured: T1:1st month
Alveolar crest-Interdental contact point (AC-IC mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Measured: T3:3rd month
Alveolar crest-Interdental contact point (AC-IC mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Measured: T6: 6th month
Alveolar crest-Papilla tip (AC-PT mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Measured: baseline
Alveolar crest-Papilla tip (AC-PT mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Measured: T1:1st month
Alveolar crest-Papilla tip (AC-PT mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Measured: T3:3rd month
Alveolar crest-Papilla tip (AC-PT mm)
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Measured: T6: 6th month
Papilla tip-Interdental contact point (PT-IC mm)
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Measured: baseline
Papilla tip-Interdental contact point (PT-IC mm)
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Measured: T1:1st month
Papilla tip-Interdental contact point (PT-IC mm)
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Measured: T3:3rd month
Papilla tip-Interdental contact point (PT-IC mm)
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Measured: T6: 6th month
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area.
Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Measured: baseline
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area.
Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Measured: T1:1st month
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area.
Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Measured: T3:3rd month
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area.
Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Measured: T6: 6th month
Interdental Tissue Stroke (ITS) (Jemt's classification system)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system
Score 0: No papilla is present
Score 1: Less than half of the height of the papilla is present
Score 2: Half or more of the height of the papilla is present
Score 3: The papilla fills up the entire proximal space
Measured: baseline
Interdental Tissue Stroke (ITS) (Jemt's classification system)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system
Score 0: No papilla is present
Score 1: Less than half of the height of the papilla is present
Score 2: Half or more of the height of the papilla is present
Score 3: The papilla fills up the entire proximal space
Measured: T1:1st month
Interdental Tissue Stroke (ITS) (Jemt's classification system)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system
Score 0: No papilla is present
Score 1: Less than half of the height of the papilla is present
Score 2: Half or more of the height of the papilla is present
Score 3: The papilla fills up the entire proximal space
Measured: T3:3rd month
Interdental Tissue Stroke (ITS) (Jemt's classification system)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system
Score 0: No papilla is present
Score 1: Less than half of the height of the papilla is present
Score 2: Half or more of the height of the papilla is present
Score 3: The papilla fills up the entire proximal space
Measured: T6: 6th month
Papilla presence index (PPI) (by Cardaropoli et al.)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure.
PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible.
PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Measured: baseline
Papilla presence index (PPI) (by Cardaropoli et al.)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure.
PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible.
PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Measured: T1:1st month
Papilla presence index (PPI) (by Cardaropoli et al.)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure.
PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible.
PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Measured: T3:3rd month
Papilla presence index (PPI) (by Cardaropoli et al.)
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure.
PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible.
PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Measured: T6: 6th month
Secondary outcomes (27)
Gingival index (GI) ( by Löe & Silness 1963)
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
The GI uses the following scoring system:
0 = normal gingiva
- = mild inflammation: slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, and glazing, or bleeding on probing
- = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: baseline
Gingival index (GI) ( by Löe & Silness 1963)
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
The GI uses the following scoring system:
0 = normal gingiva
- = mild inflammation: slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, and glazing, or bleeding on probing
- = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: T1:1st month
Gingival index (GI) ( by Löe & Silness 1963)
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
The GI uses the following scoring system:
0 = normal gingiva
- = mild inflammation: slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, and glazing, or bleeding on probing
- = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: T3:3rd month
Gingival index (GI) ( by Löe & Silness 1963)
The Gingival Index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
The GI uses the following scoring system:
0 = normal gingiva
- = mild inflammation: slight change in color, slight edema, no bleeding on probing
- = moderate inflammation: redness, edema, and glazing, or bleeding on probing
- = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding, ulceration The GI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: T6: 6th month
Gingival recession (GR-mm)
The distance between buccal CEJ and the most coronal extent marginal gingiva was reported as GR.
(measurements are in millimeters)
Measured: baseline
Gingival recession (GR-mm)
The distance between buccal CEJ and the most coronal extent marginal gingiva was reported as GR.
(measurements are in millimeters)
Measured: T1:1st month
Gingival recession (GR-mm)
The distance between buccal CEJ and the most coronal extent marginal gingiva was reported as GR.
(measurements are in millimeters)
Measured: T3:3rd month
Gingival recession (GR-mm)
The distance between buccal CEJ and the most coronal extent marginal gingiva was reported as GR.
(measurements are in millimeters)
Measured: T6: 6th month
Keratinized tissue width (KTW-mm)
It extends from the free gingival margin to the mucogingival junction and consists of the free gingiva as well as the attached gingiva. The distance between the most coronal extent free gingiva in buccal and the most coronal extent mucogingival junction was reported as KTW. (measurements are in millimeters)
Measured: baseline
Keratinized tissue width (KTW-mm)
It extends from the free gingival margin to the mucogingival junction and consists of the free gingiva as well as the attached gingiva. The distance between the most coronal extent free gingiva in buccal and the most coronal extent mucogingival junction was reported as KTW. (measurements are in millimeters)
Measured: T1:1st month
Keratinized tissue width (KTW-mm)
It extends from the free gingival margin to the mucogingival junction and consists of the free gingiva as well as the attached gingiva. The distance between the most coronal extent free gingiva in buccal and the most coronal extent mucogingival junction was reported as KTW. (measurements are in millimeters)
Measured: T3:3rd month
Keratinized tissue width (KTW-mm)
It extends from the free gingival margin to the mucogingival junction and consists of the free gingiva as well as the attached gingiva. The distance between the most coronal extent free gingiva in buccal and the most coronal extent mucogingival junction was reported as KTW. (measurements are in millimeters)
Measured: T6: 6th month
Pocket depth (PD-mm)
Periodontal probe was positioned in the gingival sulcus . The distance between the top of the free gingiva and the bottom of the sulcus was reported as PD. (measurements are in millimeters)
Measured: baseline
Pocket depth (PD-mm)
Periodontal probe was positioned in the gingival sulcus . The distance between the top of the free gingiva and the bottom of the sulcus was reported as PD. (measurements are in millimeters)
Measured: T1:1st month
Pocket depth (PD-mm)
Periodontal probe was positioned in the gingival sulcus . The distance between the top of the free gingiva and the bottom of the sulcus was reported as PD. (measurements are in millimeters)
Measured: T3:3rd month
Pocket depth (PD-mm)
Periodontal probe was positioned in the gingival sulcus . The distance between the top of the free gingiva and the bottom of the sulcus was reported as PD. (measurements are in millimeters)
Measured: T6: 6th month
Plaque index (PI) (by Silness & Löe 1964 )
0- No plaque
- -A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
- -Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- -Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
The PI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: baseline
Plaque index (PI) (by Silness & Löe 1964 )
0- No plaque
- -A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
- -Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- -Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
The PI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: T1:1st month
Plaque index (PI) (by Silness & Löe 1964 )
0- No plaque
- -A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
- -Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- -Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
The PI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: T3:3rd month
Plaque index (PI) (by Silness & Löe 1964 )
0- No plaque
- -A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
- -Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
- -Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
The PI of the individual can be obtained by adding the values of each tooth and dividing by the number of teeth examined.
Measured: T6: 6th month
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
The PBI has proven to be particularly useful for assessing inflammation in the interdental papillae by recording bleeding on probing in the interdental areas during the course of treatment.
Grade 0- no bleeding, normal papilla Grade 1- 20-30 seconds after probing the mesial and distal sulcus with a periodontal probe, a single bleeding point is observed.
Grade 2- A fine line of blood or several bleeding points become visible at the gingival margin.
Grade 3- Triangle The interdental triangle becomes more or less filled with blood Grade 4- Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva The PBI is calculated by dividing the bleeding number by the total number of papilla examined.
Measured: baseline
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
The PBI has proven to be particularly useful for assessing inflammation in the interdental papillae by recording bleeding on probing in the interdental areas during the course of treatment.
Grade 0- no bleeding, normal papilla Grade 1- 20-30 seconds after probing the mesial and distal sulcus with a periodontal probe, a single bleeding point is observed.
Grade 2- A fine line of blood or several bleeding points become visible at the gingival margin.
Grade 3- Triangle The interdental triangle becomes more or less filled with blood Grade 4- Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva The PBI is calculated by dividing the bleeding number by the total number of papilla examined.
Measured: T1:1st month
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
The PBI has proven to be particularly useful for assessing inflammation in the interdental papillae by recording bleeding on probing in the interdental areas during the course of treatment.
Grade 0- no bleeding, normal papilla Grade 1- 20-30 seconds after probing the mesial and distal sulcus with a periodontal probe, a single bleeding point is observed.
Grade 2- A fine line of blood or several bleeding points become visible at the gingival margin.
Grade 3- Triangle The interdental triangle becomes more or less filled with blood Grade 4- Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva The PBI is calculated by dividing the bleeding number by the total number of papilla examined.
Measured: T3:3rd month
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
The PBI has proven to be particularly useful for assessing inflammation in the interdental papillae by recording bleeding on probing in the interdental areas during the course of treatment.
Grade 0- no bleeding, normal papilla Grade 1- 20-30 seconds after probing the mesial and distal sulcus with a periodontal probe, a single bleeding point is observed.
Grade 2- A fine line of blood or several bleeding points become visible at the gingival margin.
Grade 3- Triangle The interdental triangle becomes more or less filled with blood Grade 4- Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva The PBI is calculated by dividing the bleeding number by the total number of papilla examined.
Measured: T6: 6th month
Patient-based variables
Evaluation was made using the Visual Analog Scale( VAS- 0-10). The experienced pain values, the aesthetic expectations , The gained aesthetics / difficulty variables. these three criteria were evaluated together ( patient satisfaction )
Measured: T1:1st month
Patient-based variables
Evaluation was made using the Visual Analog Scale( VAS- 0-10). The experienced pain values, the aesthetic expectations , The gained aesthetics / difficulty variables. these three criteria were evaluated together ( patient satisfaction )
Measured: T3:3rd month
Patient-based variables
Evaluation was made using the Visual Analog Scale( VAS- 0-10). The experienced pain values, the aesthetic expectations , The gained aesthetics / difficulty variables. these three criteria were evaluated together ( patient satisfaction )
Measured: T6: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start5 Sep 2018
- Primary completion1 Nov 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla ReconstructionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcen Ozcan Bulut, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207696
- Sponsor's protocol ID
- GO 18/780
- Status last verified
- Feb 2022
- First submitted
- 1 Dec 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma E, Sharma A, Singh K. The role of subepithelial connective tissue graft for reconstruction of interdental papilla: Clinical study. Singapore Dent J. 2017 Dec;38:27-38. doi: 10.1016/j.sdj.2017.05.001.
PubMed 29229072Singh D, Jhingran R, Bains VK, Madan R, Srivastava R. Efficacy of Platelet-rich Fibrin in Interdental Papilla Reconstruction as Compared to Connective Tissue Using Microsurgical Approach. Contemp Clin Dent. 2019 Oct-Dec;10(4):643-651. doi: 10.4103/ccd.ccd_936_18.
PubMed 32792824Carnio J, Carnio AT. Papilla reconstruction: Interdisciplinary consideration for clinical success. J Esthet Restor Dent. 2018 Nov;30(6):484-491. doi: 10.1111/jerd.12411. Epub 2018 Sep 8.
PubMed 30195268
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Platelet-rich Fibrin and Connective Tissue Graft in Interdental Papilla Reconstruction: A Retrospective Trial
- ClinicalTrials.gov ID
- NCT05207696
- Acronym / sponsor ID
- GO 18/780
- Conditions
- To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction, To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction
- Keywords
- connective tissue graft, papilla reconstruction, platelet rich fibrin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To evaluate the efficacy of platelet-rich fibrin (PRF) or connective tissue graft (CTG) in papilla reconstruction (PR) with semilunar incision (SI) technique.
Materials and Methods: A total of 55 sites (27 CTG and 28 PRF) from 20 patients who underwent PR with either PRF or CTG placed with SI in the maxillary anterior region were included in the study. Baseline (BL) and follow-up (T1( first month), T3 (third month), T6 (sixth month)) clinical data including periodontal evaluations (gingival index (GI), plaque index (PI), papillary bleeding index, pocket depth (PD), keratinized tissue width (KTW), gingival recession), papilla-associated recordings (alveolar crest-interdental contact point (AC-IC), alveolar crest-papilla tip (AC-PT), papilla tip-interdental contact point (PT-IC), papilla height loss (PHL), interdental tissue stroke (ITS) and papilla presence index (PPI)) and patient satisfaction were analyzed.
Detailed description
PT-IC was taken as the primary outcome measure. Normal distribution was assessed by histogram and Shapiro-Wilk test. Continuous variables were represented as mean±SD whereas the categorical variables were reported as numbers and percentages. Chi-square test was used for the comparison of the categorical variables. Since the data was normally distributed, Friedman test was used to analyze the time-dependent changes in both groups and the inter-group comparisons were made with Mann-Whitney test. Generalized Estimating Equation was used for analyzing qualitative and quantitative data, time-dependent changes, and the difference between two methods. Data analysis was performed in IBM SPSS Statistics Version 23, and p<0.05 was considered as a significance threshold.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich fibrin (PRF) | – | Other: retrospective data analysisA total of 28 sites from 12 patients who underwent papilla reconstruction with PRF placed with semilunar incision in the maxillary anterior region were included in PRF group. ( Data of 12 patients were included in the study.) |
| Connective tissue graft (CTG) | – | Other: retrospective data analysisA total of 27 sites from 8 patients who underwent papilla reconstruction with CTG placed with semilunar incision in the maxillary anterior region were included in CTG group. (Data of 8 patients were included in the study.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In Hacettepe University Periodontology Department (Jun 2016-Feb 2018), 186 patients treated with PR were scanned and the data of 55 sites (27 CTG and 28 PRF) from 20 patients meeting the criteria were included.
Key inclusion criteria (4 listed)
- All selected patients had consent for using their data.
- The data of the patients who underwent PR surgery by one of the authors (S.O.B.) using SI with either PRF or CTG in the maxillary anterior teeth having contact points,
- at least 2 mm keratinized tissue width (KTW) with probing depth (PD)≤ 3 mm adjacent to the open embrasure were included.
- It was ensured that all baseline (BL) and follow-up data were available and all patients received a comprehensive phase I periodontal treatment prior to the PR procedure.
Key exclusion criteria (4 listed)
- the patients with systemic problems,
- having medications known to influence the periodontium
- Using tobacco/alcohol
- The relevant regions did not have endodontic problems/needs, caries and history of periodontal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective data analysisThe data of the patients who underwent papilla reconstruction surgery by one of the authors (S.O.B.) using semilunar incision with either PRF or CTG in the maxillary anterior teeth were included in the study. All selected patients had consent for using their data.The data of the patients included in the study were analyzed.(Baseline (BL) and follow-up (T1( first month) , T3 (third month), T6 (sixth month)) clinical data including periodontal evaluations (gingival index (GI), plaque index (PI), papillary bleeding index, pocket depth (PD), keratinized tissue width (KTW), gingival recession), papilla-associated recordings (alveolar crest-interdental contact point (AC-IC), alveolar crest-papilla tip (AC-PT), papilla tip-interdental contact point (PT-IC), papilla height loss (PHL), interdental tissue stroke (ITS) and papilla presence index (PPI)) and patient satisfaction were analyzed.) | Other | Connective tissue graft (CTG), Platelet-rich fibrin (PRF) |
Primary outcome
Alveolar crest-Interdental contact point (AC-IC mm)
Time frame: baseline
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Alveolar crest-Interdental contact point (AC-IC mm)
Time frame: T1:1st month
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Alveolar crest-Interdental contact point (AC-IC mm)
Time frame: T3:3rd month
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Alveolar crest-Interdental contact point (AC-IC mm)
Time frame: T6: 6th month
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and interdental contact point was reported as AC-IC . (measurements are in millimeters)
Alveolar crest-Papilla tip (AC-PT mm)
Time frame: baseline
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Alveolar crest-Papilla tip (AC-PT mm)
Time frame: T1:1st month
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Alveolar crest-Papilla tip (AC-PT mm)
Time frame: T3:3rd month
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Alveolar crest-Papilla tip (AC-PT mm)
Time frame: T6: 6th month
Crestal bone height was measured after administering local anesthesia for each mesiofacial or distofacial test site. UNC-15(HuFriedy, Chicago, IL, USA) periodontal probe was positioned inter-proximally in the gingival sulcus in a corono - apical direction which was parallel to the long axis of the tooth. The probe was advanced apically until it contacted the crest of the alveolar bone. The distance between the crestal bone and the tip of the interdental papilla was reported as AC-PT. (measurements are in millimeters)
Papilla tip-Interdental contact point (PT-IC mm)
Time frame: baseline
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Papilla tip-Interdental contact point (PT-IC mm)
Time frame: T1:1st month
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Papilla tip-Interdental contact point (PT-IC mm)
Time frame: T3:3rd month
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Papilla tip-Interdental contact point (PT-IC mm)
Time frame: T6: 6th month
the periodontal probe was positioned inter-proximally. The distance between interdental contact point and the tip of the interdental papilla was reported as PT-IC. (measurements are in millimeters)
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Time frame: baseline
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Time frame: T1:1st month
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Time frame: T3:3rd month
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Papilla Height Loss (PHL)(Nordland and Tarnow classification system)
Time frame: T6: 6th month
Each interdental papilla was scored as 0-3 based upon Nordland and Tarnow's classification system The following scores were assigned to the papilla at baseline, T1,T3 and T6. Normal:Interdental papilla fills embrasure space to the apical extent of the interdental contact point/area. Class-I. The tip of the interdental papilla lies between the interdental contact point and the most coronal extent of the inter proximal CEJ (the cemento-enamel junction) (space present but inter proximal CEJ is not visible) Class-II.The tip of the interdental papilla lies at or apical to the interproximal CEJ but coronal to the apical extent of the facial CEJ(interproximal CEJ visible) Class-III.The tip of the interdental papilla lies level with or apical to the facial CEJ
Interdental Tissue Stroke (ITS) (Jemt's classification system)
Time frame: baseline
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space
Interdental Tissue Stroke (ITS) (Jemt's classification system)
Time frame: T1:1st month
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space
Interdental Tissue Stroke (ITS) (Jemt's classification system)
Time frame: T3:3rd month
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space
Interdental Tissue Stroke (ITS) (Jemt's classification system)
Time frame: T6: 6th month
The following scores were assigned to the papilla at baseline, T1,T3 and T6. Each interdental papilla was scored as 0-3 based upon Jemt's classification system Score 0: No papilla is present Score 1: Less than half of the height of the papilla is present Score 2: Half or more of the height of the papilla is present Score 3: The papilla fills up the entire proximal space
Papilla presence index (PPI) (by Cardaropoli et al.)
Time frame: baseline
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Papilla presence index (PPI) (by Cardaropoli et al.)
Time frame: T1:1st month
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Papilla presence index (PPI) (by Cardaropoli et al.)
Time frame: T3:3rd month
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
Papilla presence index (PPI) (by Cardaropoli et al.)
Time frame: T6: 6th month
The following scores were assigned to the papilla at baseline, T1,T3 and T6. PPI 1: the papilla is completely present and coronally extends to the contact point to completely fill the interproximal embrasure. PPI 2: the papilla is no longer completely present and lies apical to the contact point. But the interproximal CEJ (iCEJ) is still not visible. PPI 3: the papilla is moved more apical and iCEJ becomes visible. PPI 4: the papilla lies apcal to both iCEJ and buccal CEJ. Each interdental papilla was scored as 1-3 based upon PPI.
27 secondary outcomes
Gingival index (GI) ( by Löe & Silness 1963)
Time frame: baseline
Gingival index (GI) ( by Löe & Silness 1963)
Time frame: T1:1st month
Gingival index (GI) ( by Löe & Silness 1963)
Time frame: T3:3rd month
Gingival index (GI) ( by Löe & Silness 1963)
Time frame: T6: 6th month
Gingival recession (GR-mm)
Time frame: baseline
Gingival recession (GR-mm)
Time frame: T1:1st month
Gingival recession (GR-mm)
Time frame: T3:3rd month
Gingival recession (GR-mm)
Time frame: T6: 6th month
Keratinized tissue width (KTW-mm)
Time frame: baseline
Keratinized tissue width (KTW-mm)
Time frame: T1:1st month
Keratinized tissue width (KTW-mm)
Time frame: T3:3rd month
Keratinized tissue width (KTW-mm)
Time frame: T6: 6th month
Pocket depth (PD-mm)
Time frame: baseline
Pocket depth (PD-mm)
Time frame: T1:1st month
Pocket depth (PD-mm)
Time frame: T3:3rd month
Pocket depth (PD-mm)
Time frame: T6: 6th month
Plaque index (PI) (by Silness & Löe 1964 )
Time frame: baseline
Plaque index (PI) (by Silness & Löe 1964 )
Time frame: T1:1st month
Plaque index (PI) (by Silness & Löe 1964 )
Time frame: T3:3rd month
Plaque index (PI) (by Silness & Löe 1964 )
Time frame: T6: 6th month
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
Time frame: baseline
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
Time frame: T1:1st month
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
Time frame: T3:3rd month
Papillary Bleeding Index(PBI) (by Saxer & Muhlemann 1975)
Time frame: T6: 6th month
Patient-based variables
Time frame: T1:1st month
Patient-based variables
Time frame: T3:3rd month
Patient-based variables
Time frame: T6: 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 29229072Sharma E, Sharma A, Singh K. The role of subepithelial connective tissue graft for reconstruction of interdental papilla: Clinical study. Singapore Dent J. 2017 Dec;38:27-38. doi: 10.1016/j.sdj.2017.05.001.
- Background: PubMed 32792824Singh D, Jhingran R, Bains VK, Madan R, Srivastava R. Efficacy of Platelet-rich Fibrin in Interdental Papilla Reconstruction as Compared to Connective Tissue Using Microsurgical Approach. Contemp Clin Dent. 2019 Oct-Dec;10(4):643-651. doi: 10.4103/ccd.ccd_936_18.
- Background: PubMed 30195268Carnio J, Carnio AT. Papilla reconstruction: Interdisciplinary consideration for clinical success. J Esthet Restor Dent. 2018 Nov;30(6):484-491. doi: 10.1111/jerd.12411. Epub 2018 Sep 8.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate the Efficacy of Platelet-rich Fibrin in Papilla Reconstruction and To Evaluate the Efficacy of Connective Tissue Graft in Papilla Reconstruction, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar crest-Interdental contact point (AC-IC mm) (time frame: baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05207696, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.