Chronic PeriodontitisEarly Phase 1NCT04082949
Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
A Early Phase 1 study testing autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis in people with Chronic Periodontitis and Periodontal Pocket, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Chronic periodontitis is an inflammatory and polymicrobic disease characterized by the irreversible loss of alveolar bone and connective tissue attachment of the teeth. Chronic periodontitis is the most prevalent type of periodontitis and it is seen in the great majority of the adult population. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Chronic Periodontitis, Periodontal Pocket, Periodontal Attachment Loss
- What is being tested?
- autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 15 May 2019
- Phase
- Early Phase 1
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with moderate/severe chronic periodontitis;
- Being older than 18 years;
- Presence of at least three teeth in each quadrant with ≥5 mm probing pocket; depth and ≥3 mm clinical attachment loss;
- Being systemically healthy;
- Not smoking cigarettes.
Who cannot join
- Presence of a systemic disease (diabetes, hypertension, coagulopathy, radiotherapy, chemotherapy, etc.);
- Use of any drugs that could influence the results of the study;
- Periodontal treatment in the last six months before the study, or use of antibiotics in the last six months;
- Smoking or alcohol consumption;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Dentistry, Department of Periodontology, İnonu University
Malatya, 44280
About this study
Official title: Evaluation of Clinical Effects of Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
Chronic periodontitis is an inflammatory and polymicrobic disease characterized by the irreversible loss of alveolar bone and connective tissue attachment of the teeth. Chronic periodontitis is the most prevalent type of periodontitis and it is seen in the great majority of the adult population.
The main objective of periodontal treatment is to heal the inflammatory tissue, to eliminate unhealthy periodontal pockets, and to reduce the number of pathogenic bacteria. The traditional treatment of chronic periodontitis is debridement performed with hand tools and ultrasonic devices. However, in deep pockets, which are difficult to access, mechanical root surface debridement is not sufficient to remove the biofilm via root instrumentation.
Read more
The regeneration of the periodontium aims at the reconstitution of the periodontal ligament, alveolar bone, and cementum. Platelet concentrates have gained popularity in regenerative periodontal therapy due to their autologous nature. Their regenerative potential is associated with growth factors such as TGFβ-1, PDGF, EGF, IGF-I, and VEGF, stimulate cell proliferation and regulate matrix remodeling and angiogenesis. Growth factors are naturally occurring proteins that regulate cell growth and development. They also modulate cell proliferation, migration, extracellular matrix formation and other cellular functions in epithelization. In addition, some growth factors may function as cell differentiation factors. These functions of the growth factors support epithelization following surgical periodontal treatment and reduce postoperative pain and swelling with their anti-inflammatory properties. Furthermore, studies have reported their antibacterial potentials.
Different platelet concentrates such as platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) are obtained when whole blood is centrifuged at different speeds and for different durations. When the literature is reviewed, it is seen that these platelet concentrates are frequently used in regenerative therapies in dentistry. In 2010, Sohn et al. obtained autologous fibrin glue (AFG), an injectable platelet concentrate, by centrifuging venous blood for two minutes in a special centrifuge device (Medifuge, Silfradent, Italy; 2400-2700 rpm). AFG is used, by mixing it with bone grafts, in the production of sticky bone, which could be an alternative to titanium mesh and bone block procedures that enable grafts to remain more stable in defects.
It was found in the literature review that studies on AFG, which is a second-generation platelet concentrate, are limited in number. It was also found that these studies were conducted on sticky bone, obtained by mixing AFG with bone grafts, and there are no studies in which AFG is used alone to treat periodontal diseases. The purpose of this study is to investigate the effect of AFG, an injectable platelet concentration, on clinical parameters in the nonsurgical treatment of chronic periodontitis.
Read the detailed description
This randomized controlled clinical study included patients diagnosed with moderate/severe periodontitis who applied to the Department of Periodontology, Faculty of Dentistry, Inonu University. Written consent was received from each patient. Approval was obtained from the Malatya Clinical Research Ethics Committee for our study, which was designed in compliance with the Declaration of Helsinki.
Two random split-mouth groups were formed among the patients. One side of each patient's mouth was administered AFG following SRP (test group), while the other side of the same patient's mouth was administered a placebo drug (control group).
The following periodontal parameters were evaluated in all patients before and after SRP at the 1st, 3rd, and 6th months: probing depth (PD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) index. Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for PI and GI and in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for PD, CAL, and BOP. Clinical attachment level was measured from the enamel-cement border. Following the initial measurement, the regions with ≥5 mm pocket depth were determined. Measurements were performed only in these regions in the 1st, 3rd, and 6th months. The initial pocket depth was considered within two subgroups as regions with 5-6 mm pocket depth and regions with ≥7 mm pocket depth.
Venous blood from each patient (9 mL) was transferred into a tube without any anticoagulant. Following the protocol recommended by Sohn et al., the venous blood collected in the tube was centrifuged in a special centrifuge machine (Medifuge, Silfradent, Italy). The AFG at the top of the tube was collected using an injector.
Nonsurgical periodontal treatments of the patients were completed in two sessions by a periodontology expert.
In the first session, the supragingival calculus was removed, and patients were given oral hygiene training and encouragement. In the second session, the SRP procedure was performed under local anesthesia in the regions in which there were periodontal pockets of ≥5 mm in the quadrants considered as the control and test groups. The test group was administered AFG using a blunt dental injector in the subgingival region, as an adjunct to SRP, while the control group was administered the placebo.
- Conditions
- Chronic Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Diseases
- Being tested
- autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis, placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis
- Keywords
- Chronic Periodontitis, Autologous fibrin tissue adhesive, Blood Platelets, Non-surgical periodontal therapy
- Medical subject headings
- Chronic Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisBiological
The purpose of this study was to investigate effects of autologous fibrin glue (AFG) which was an injectable platelet concentration, on clinical parameters in the nonsurgical treatment of chronic periodontitis.Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The test group was administered AFG using a blunt dental injector in the subgingival region, as an adjunct to SRP Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months.
placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisOther
Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The control group was administered placebo as an adjunct to SRP.Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months.
| Study group | Role | What they receive |
|---|---|---|
| Subgroups:control and initial pocket depths:5-6mm | Placebo comparator | Control group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm Receives: Other: placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis |
| Subgroups:control and initial pocket depths≥7mm | Placebo comparator | Control group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm Receives: Other: placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis |
| Subgroups:AFG and initial pocket depths:5-6mm | Experimental | AFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm Receives: Biological: autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis |
| Subgroups:AFG and initial pocket depths≥7mm | Experimental | AFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm Receives: Biological: autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pocket depths (PD) in millimeters at different time points
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for PD.
Measured: Pocket depths were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
change of clinical attachment levels (CAL) in millimeters at different time points
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for CAL.
Measured: clinical attachment levels were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Secondary outcomes (3)
change of bleeding on probing(BOP) scores in % at different time points
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for BOP.
Measured: bleeding on probing scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
change of gingival index(GI) scores in levels at different time points
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for GI
Measured: gingival index scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
change of plaque index(PI) scores in levels at different time points
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for PI.
Measured: plaque index scores were evaluated in all patients bt baseline and after SRP at the 1st, 3rd, and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 May 2018
- Primary completion10 Dec 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised paralleled clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mustafa özay uslu, Inonu University
- Investigators
- MUSTAFA Ö USLU, Asst. Prof., Study director, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082949
- Sponsor's protocol ID
- 2018/45
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available. The outcomes of the treatment will publish in a journal and doesn't need a patient's data collection
Publications
Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
PubMed 12787211The potential role of growth and differentiation factors in periodontal regeneration. J Periodontol. 1996 May;67(5):545-53.
PubMed 8724716Abdul Ameer LA, Raheem ZJ, Abdulrazaq SS, Ali BG, Nasser MM, Khairi AWA. The anti-inflammatory effect of the platelet-rich plasma in the periodontal pocket. Eur J Dent. 2018 Oct-Dec;12(4):528-531. doi: 10.4103/ejd.ejd_49_18.
PubMed 30369798Kao RT, Murakami S, Beirne OR. The use of biologic mediators and tissue engineering in dentistry. Periodontol 2000. 2009;50:127-53. doi: 10.1111/j.1600-0757.2008.00287.x. No abstract available.
PubMed 19388957Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
PubMed 16332231
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Effects of Autologous Fibrin Glue Application as an Adjunct to Nonsurgical Periodontal Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT04082949
- Acronym / sponsor ID
- 2018/45
- Conditions
- Chronic Periodontitis, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Diseases
- Keywords
- Chronic Periodontitis, Autologous fibrin tissue adhesive, Blood Platelets, Non-surgical periodontal therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 10 Sep 2019 (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.
Chronic periodontitis is an inflammatory and polymicrobic disease characterized by the irreversible loss of alveolar bone and connective tissue attachment of the teeth. Chronic periodontitis is the most prevalent type of periodontitis and it is seen in the great majority of the adult population.
The main objective of periodontal treatment is to heal the inflammatory tissue, to eliminate unhealthy periodontal pockets, and to reduce the number of pathogenic bacteria. The traditional treatment of chronic periodontitis is debridement performed with hand tools and ultrasonic devices. However, in deep pockets, which are difficult to access, mechanical root surface debridement is not sufficient to remove the biofilm via root instrumentation.
The regeneration of the periodontium aims at the reconstitution of the periodontal ligament, alveolar bone, and cementum. Platelet concentrates have gained popularity in regenerative periodontal therapy due to their autologous nature. Their regenerative potential is associated with growth factors such as TGFβ-1, PDGF, EGF, IGF-I, and VEGF, stimulate cell proliferation and regulate matrix remodeling and angiogenesis. Growth factors are naturally occurring proteins that regulate cell growth and development. They also modulate cell proliferation, migration, extracellular matrix formation and other cellular functions in epithelization. In addition, some growth factors may function as cell differentiation factors. These functions of the growth factors support epithelization following surgical periodontal treatment and reduce postoperative pain and swelling with their anti-inflammatory properties. Furthermore, studies have reported their antibacterial potentials.
Different platelet concentrates such as platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) are obtained when whole blood is centrifuged at different speeds and for different durations. When the literature is reviewed, it is seen that these platelet concentrates are frequently used in regenerative therapies in dentistry. In 2010, Sohn et al. obtained autologous fibrin glue (AFG), an injectable platelet concentrate, by centrifuging venous blood for two minutes in a special centrifuge device (Medifuge, Silfradent, Italy; 2400-2700 rpm). AFG is used, by mixing it with bone grafts, in the production of sticky bone, which could be an alternative to titanium mesh and bone block procedures that enable grafts to remain more stable in defects.
It was found in the literature review that studies on AFG, which is a second-generation platelet concentrate, are limited in number. It was also found that these studies were conducted on sticky bone, obtained by mixing AFG with bone grafts, and there are no studies in which AFG is used alone to treat periodontal diseases. The purpose of this study is to investigate the effect of AFG, an injectable platelet concentration, on clinical parameters in the nonsurgical treatment of chronic periodontitis.
Detailed description
This randomized controlled clinical study included patients diagnosed with moderate/severe periodontitis who applied to the Department of Periodontology, Faculty of Dentistry, Inonu University. Written consent was received from each patient. Approval was obtained from the Malatya Clinical Research Ethics Committee for our study, which was designed in compliance with the Declaration of Helsinki.
Two random split-mouth groups were formed among the patients. One side of each patient's mouth was administered AFG following SRP (test group), while the other side of the same patient's mouth was administered a placebo drug (control group).
The following periodontal parameters were evaluated in all patients before and after SRP at the 1st, 3rd, and 6th months: probing depth (PD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and bleeding on probing (BOP) index. Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 4 regions (mesiobuccal, midbuccal, distobuccal, midlingual) for PI and GI and in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for PD, CAL, and BOP. Clinical attachment level was measured from the enamel-cement border. Following the initial measurement, the regions with ≥5 mm pocket depth were determined. Measurements were performed only in these regions in the 1st, 3rd, and 6th months. The initial pocket depth was considered within two subgroups as regions with 5-6 mm pocket depth and regions with ≥7 mm pocket depth.
Venous blood from each patient (9 mL) was transferred into a tube without any anticoagulant. Following the protocol recommended by Sohn et al., the venous blood collected in the tube was centrifuged in a special centrifuge machine (Medifuge, Silfradent, Italy). The AFG at the top of the tube was collected using an injector.
Nonsurgical periodontal treatments of the patients were completed in two sessions by a periodontology expert.
In the first session, the supragingival calculus was removed, and patients were given oral hygiene training and encouragement. In the second session, the SRP procedure was performed under local anesthesia in the regions in which there were periodontal pockets of ≥5 mm in the quadrants considered as the control and test groups. The test group was administered AFG using a blunt dental injector in the subgingival region, as an adjunct to SRP, while the control group was administered the placebo.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Randomised paralleled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Subgroups:control and initial pocket depths:5-6mm | Placebo comparator | Other: placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisControl group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm |
| Subgroups:control and initial pocket depths≥7mm | Placebo comparator | Other: placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisControl group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm |
| Subgroups:AFG and initial pocket depths:5-6mm | Experimental | Biological: autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisAFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths:5-6mm |
| Subgroups:AFG and initial pocket depths≥7mm | Experimental | Biological: autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisAFG group divided into two subgroups according to initial pocket depths and this subgroup includes initial pocket depths higher than 7mm |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being diagnosed with moderate/severe chronic periodontitis;
- Being older than 18 years;
- Presence of at least three teeth in each quadrant with ≥5 mm probing pocket; depth and ≥3 mm clinical attachment loss;
- Being systemically healthy;
- Not smoking cigarettes.
Key exclusion criteria (5 listed)
- Presence of a systemic disease (diabetes, hypertension, coagulopathy, radiotherapy, chemotherapy, etc.);
- Use of any drugs that could influence the results of the study;
- Periodontal treatment in the last six months before the study, or use of antibiotics in the last six months;
- Smoking or alcohol consumption;
- Pregnancy.
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 |
|---|---|---|
| autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisThe purpose of this study was to investigate effects of autologous fibrin glue (AFG) which was an injectable platelet concentration, on clinical parameters in the nonsurgical treatment of chronic periodontitis.Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The test group was administered AFG using a blunt dental injector in the subgingival region, as an adjunct to SRP Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months. | Biological | Subgroups:AFG and initial pocket depths:5-6mm, Subgroups:AFG and initial pocket depths≥7mm |
| placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitisSeventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The control group was administered placebo as an adjunct to SRP.Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months. | Other | Subgroups:control and initial pocket depths:5-6mm, Subgroups:control and initial pocket depths≥7mm |
Primary outcome
change of pocket depths (PD) in millimeters at different time points
Time frame: Pocket depths were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for PD.
change of clinical attachment levels (CAL) in millimeters at different time points
Time frame: clinical attachment levels were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
Measurements were performed using a Williams probe (Hu-Friedy, Chicago, IL, USA) for all teeth except for the third molars, in 6 regions (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) for CAL.
3 secondary outcomes
change of bleeding on probing(BOP) scores in % at different time points
Time frame: bleeding on probing scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
change of gingival index(GI) scores in levels at different time points
Time frame: gingival index scores were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months
change of plaque index(PI) scores in levels at different time points
Time frame: plaque index scores were evaluated in all patients bt baseline and after SRP at the 1st, 3rd, and 6th months
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 10 Sep 2019.
- Background: PubMed 12787211Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
- Background: PubMed 8724716The potential role of growth and differentiation factors in periodontal regeneration. J Periodontol. 1996 May;67(5):545-53.
- Background: PubMed 30369798Abdul Ameer LA, Raheem ZJ, Abdulrazaq SS, Ali BG, Nasser MM, Khairi AWA. The anti-inflammatory effect of the platelet-rich plasma in the periodontal pocket. Eur J Dent. 2018 Oct-Dec;12(4):528-531. doi: 10.4103/ejd.ejd_49_18.
- Background: PubMed 19388957Kao RT, Murakami S, Beirne OR. The use of biologic mediators and tissue engineering in dentistry. Periodontol 2000. 2009;50:127-53. doi: 10.1111/j.1600-0757.2008.00287.x. No abstract available.
- Background: PubMed 16332231Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available. The outcomes of the treatment will publish in a journal and doesn't need a patient's data collection
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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.
MUSTAFA Ö USLU, Asst. Prof. study director
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis in people with Chronic Periodontitis and Periodontal Pocket, run by Inonu 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 5 inclusion and 5 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 10 Sep 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change of pocket depths (PD) in millimeters at different time points (time frame: Pocket depths were evaluated in all patients at baseline and after SRP at the 1st, 3rd, and 6th months). The study lists 2 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 NCT04082949, which also lists 5 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 10 Sep 2019.