Gingival Recession, LocalizedNCT06373783
Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage
A study testing subepithelial connective tissue graft, de- epithelize gingival graft and ultrasonography in people with Gingival Recession, Localized, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- subepithelial connective tissue graft, de- epithelize gingival graft and ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2023to 16 Mar 2024
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with single Miller class 1 or 2 gingival recession who have undergone root coverage surgery.
- 18 to 65 years old
- non-smoker and non-alcoholic.
- Patients who have good oral hygiene and whose inflammation can be controlled (FMPS <25%, FMBS <25%, probing depth ≤ 3mm, and bleeding on probing <10%)
- Those who have no previous history of periodontal surgery in the operation area
Who cannot join
- Active smokers
- pregnancy and lactation
- Continuation of gingival trauma due to false tooth brushing
- Presence of severe tooth malposition
- Those with systemic diseases that may affect wound healing after periodontal surgery
- Individuals who cannot maintain oral hygiene
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University of the Dentistry
Denizli, 20160
About this study
Official title: Ultrasonographic Evaluation of the Efficacy of Subepithelial Connective Tissue Grafts Versus De-epithelized Gingival Graft in Root Coverage With Coronally Advanced Flap Technique
Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.
Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.
Read more
De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.
Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.
The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG).
Read the detailed description
The study was planned as a randomized controlled study. Patients with single Miller class 1 or 2 gingival recession who need root coverage surgery in the Department of Periodontology were included in the study. In combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a de-epithelialized gingival graft or a subepithelial gingival graft. The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of the canine and the mesial of the first molar in the palate. Connective tissue dimensions were approximately 10 X 5 X 2 mm. Finally, the incision line was sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture. The de-epithelized gingival graft was taken in a rectangular shape from the area located on the palatal side of the maxillary canine and the first molar tooth, and then it was de-epithelized with the help of a scalpel. After the graft was stabilized to the recipient area with a 5-0 resorbable, sterile monofilament suture. The flap was repositioned and sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture.
Clinical measurements (probing depth (PD), clinical attachment level (CAL), gingival recession depth and width, keratinized tissue width and height) were taken on the day of surgery, the 3rd days, the 14th days, the 1st month, the 3rd months and the 6th months.
Patients were evaluated using an ultrasonography device ( MyLabtm Seven, Esaote, Genoa, Italy) at the Department of Oral and Maxillofacial Radiology.
USG measurements were performed on days 0, 3, 14, 30, 90, and 180 for buccal tissue thickness and tissue vascularization by an oral and maxillofacial radiologist with at least six years of experience. A 6-8 MHZ intraoral probe was used in intraoral USG examinations. Steril gel was applied to the intraoral probe and covered with stretch film. Then, it was placed directly on the buccal mucosal surface. Mucosal thickness was evaluated using the B-mode of the device, and vascularization was evaluated using the color Doppler and pulsed wave Doppler modes of the device. mean pulsatility index (PI) values of each patient were calculated and considered for statistical analysis.
The power analysis of the study was performed for sample size calculation. In the power analysis, when α = 0.05, β = 0.40, 1-β: 0.80, the number of regions to be included in the study was determined as 20 for each group. The sample size was calculated with a statistical program.
The data obtained from the study is the 22. version of SPSS. (SPSS Inc., Chicago, IL) descriptive analysis, means and standard deviations were calculated for all clinical effects, and USG measurements. Repeated measures analysis of variance was used for intragroup comparisons before and after treatment. The normality of data distributions of the groups was measured with the Kolmogorov-Smirnov test. In the comparison of groups, an independent groups t-test was used if the data distributions were normal, and Mann Whitney U test was used if the data distribution was not normal. The significance value was taken as p<00.5.m (G*Power; Universitat, Dusseldorf, Germany).
- Conditions
- Gingival Recession, Localized
- Being tested
- subepithelial connective tissue graft, de- epithelize gingival graft, ultrasonography
- Keywords
- Connective tissue graft, gingival recession, ultrasonography, de-epithelized gingival graft, tissue thickness, blood-flow velocity
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subepithelial connective tissue graftProcedure or surgery
The area where the gingival recession occurred was prepared with the modified coronally positioned flap technique developed by Zuchelli. The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of the canine and the mesial of the first molar in the palate. Connective tissue dimensions were approximately 10x5x2 mm. The graft thickness was measured with an endodontic spreader from 3 points (mesial, buccal, and distal) and an electronic caliper during surgery.
de- epithelize gingival graftProcedure or surgery
The area where the gingival recession occurred was prepared with the modified coronally positioned flap technique developed by Zuchelli. A shallow horizontal incision was made at ≈3 mm apical from the gingival margin of the maxillary molar teeth using a number 15 scalpel blade. Subsequently, a parallel horizontal incision, at ≈ 4 mm apical from the first horizontal incision, was traced in conjunction with two vertical releasing incisions to delineate a rectangular area. Then, the uppermost epithelial layer was scraped off using a size 11 scalpel tip. The connective tissue graft to be taken from the palate area was 10x5x2 mm in size, and the graft thickness was measured with an endodontic spreader from 3 points (mesial, buccal, and distal) and electronic caliper during surgery.
ultrasonographyDiagnostic test
Clinical parameter measurements (probing depth (PD), clinical attachment level (CAL), gingival recession depth and width, keratinized tissue width and height) were taken on the day of surgery, the 3rd days, the 14th days, the 1st month, the 3rd months and the 6th months.
Ultrasonography measurements A 6-18 MHz intraoral probe was used in intraoral USG examinations. Sterile gel was applied to the intraoral probe and covered with a stretch film. Then, it was placed directly on the mucosal surface of the receiver site in the buccal area. Mucosal thickness was evaluated using the B-mode of the device, and vascularization was evaluated using the color doppler and pulsed wave doppler modes of the device. The following equation is used and calculated by US unit pulsatility index (PI) = (Vmax-Vmin) (Vmean) (Vmax is peak systolic flow velocity. Vmin is diastolic flow velocity and Vmean is mean flow velocity.) The mean PI values of each patient were measured.
| Study group | Role | What they receive |
|---|---|---|
| de-epithelise | Active comparator | In combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a de-epithelialized gingival graft. The gingival graft was taken in a rectangular shape from the area located on the palatal side of the maxillary canine and the first molar tooth, and then it was de-epithelised with the help of a scalpel. Receives: Procedure: de- epithelize gingival graft; Diagnostic Test: ultrasonography |
| subepithelial | Active comparator | In combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a subepithelial gingival graft. Connective tissue taken from the upper jaw-palate region with a single incision technique was used. Receives: Procedure: subepithelial connective tissue graft; Diagnostic Test: ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue thickness
tissue thickness was measured with B-Mod mod of ultrasonography device
Measured: at baseline before operation, on days 3,14, 30, 90,180
Secondary outcomes (1)
pulsatility index
pulsatility index was measured with Doppler-mode of ultrasonography device.
Measured: at baseline before operation, on days 3,14,30,90,180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start15 Jun 2023
- Primary completion15 Jan 2024
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Torumtay Cin, Pamukkale University
- Investigators
- GİZEM TORUMTAY CİN, assist prof., Principal investigator, PAMUKKALE UNIVERSITY FACULTY of DENTISTIRY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373783
- Sponsor's protocol ID
- 2023/05
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Efficacy of Subepithelial Connective Tissue Grafts Versus De-epithelized Gingival Graft in Root Coverage With Coronally Advanced Flap Technique
- ClinicalTrials.gov ID
- NCT06373783
- Acronym / sponsor ID
- 2023/05
- Conditions
- Gingival Recession, Localized
- Keywords
- Connective tissue graft, gingival recession, ultrasonography, de-epithelized gingival graft, tissue thickness, blood-flow velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 18 Apr 2024 (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.
Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.
Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.
De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.
Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.
The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG).
Detailed description
The study was planned as a randomized controlled study. Patients with single Miller class 1 or 2 gingival recession who need root coverage surgery in the Department of Periodontology were included in the study. In combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a de-epithelialized gingival graft or a subepithelial gingival graft. The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of the canine and the mesial of the first molar in the palate. Connective tissue dimensions were approximately 10 X 5 X 2 mm. Finally, the incision line was sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture. The de-epithelized gingival graft was taken in a rectangular shape from the area located on the palatal side of the maxillary canine and the first molar tooth, and then it was de-epithelized with the help of a scalpel. After the graft was stabilized to the recipient area with a 5-0 resorbable, sterile monofilament suture. The flap was repositioned and sutured with 5/0 synthetic, nonabsorbable, sterile monofilament suture.
Clinical measurements (probing depth (PD), clinical attachment level (CAL), gingival recession depth and width, keratinized tissue width and height) were taken on the day of surgery, the 3rd days, the 14th days, the 1st month, the 3rd months and the 6th months.
Patients were evaluated using an ultrasonography device ( MyLabtm Seven, Esaote, Genoa, Italy) at the Department of Oral and Maxillofacial Radiology.
USG measurements were performed on days 0, 3, 14, 30, 90, and 180 for buccal tissue thickness and tissue vascularization by an oral and maxillofacial radiologist with at least six years of experience. A 6-8 MHZ intraoral probe was used in intraoral USG examinations. Steril gel was applied to the intraoral probe and covered with stretch film. Then, it was placed directly on the buccal mucosal surface. Mucosal thickness was evaluated using the B-mode of the device, and vascularization was evaluated using the color Doppler and pulsed wave Doppler modes of the device. mean pulsatility index (PI) values of each patient were calculated and considered for statistical analysis.
The power analysis of the study was performed for sample size calculation. In the power analysis, when α = 0.05, β = 0.40, 1-β: 0.80, the number of regions to be included in the study was determined as 20 for each group. The sample size was calculated with a statistical program.
The data obtained from the study is the 22. version of SPSS. (SPSS Inc., Chicago, IL) descriptive analysis, means and standard deviations were calculated for all clinical effects, and USG measurements. Repeated measures analysis of variance was used for intragroup comparisons before and after treatment. The normality of data distributions of the groups was measured with the Kolmogorov-Smirnov test. In the comparison of groups, an independent groups t-test was used if the data distributions were normal, and Mann Whitney U test was used if the data distribution was not normal. The significance value was taken as p<00.5.m (G*Power; Universitat, Dusseldorf, Germany).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| de-epithelise | Active comparator | Procedure: de- epithelize gingival graft, Diagnostic Test: ultrasonographyIn combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a de-epithelialized gingival graft. The gingival graft was taken in a rectangular shape from the area located on the palatal side of the maxillary canine and the first molar tooth, and then it was de-epithelised with the help of a scalpel. |
| subepithelial | Active comparator | Procedure: subepithelial connective tissue graft, Diagnostic Test: ultrasonographyIn combination with Zuchelli's coronally positioned flap technique, gingival recession in the upper jaw premolar region was treated using a subepithelial gingival graft. Connective tissue taken from the upper jaw-palate region with a single incision technique was used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with single Miller class 1 or 2 gingival recession who have undergone root coverage surgery.
- 18 to 65 years old
- non-smoker and non-alcoholic.
- Patients who have good oral hygiene and whose inflammation can be controlled (FMPS <25%, FMBS <25%, probing depth ≤ 3mm, and bleeding on probing <10%)
- Those who have no previous history of periodontal surgery in the operation area
Key exclusion criteria (6 listed)
- Active smokers
- pregnancy and lactation
- Continuation of gingival trauma due to false tooth brushing
- Presence of severe tooth malposition
- Those with systemic diseases that may affect wound healing after 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 |
|---|---|---|
| subepithelial connective tissue graftThe area where the gingival recession occurred was prepared with the modified coronally positioned flap technique developed by Zuchelli. The subepithelial connective tissue graft was obtained in each patient using the single incision technique from the region between the mesial of the canine and the mesial of the first molar in the palate. Connective tissue dimensions were approximately 10x5x2 mm. The graft thickness was measured with an endodontic spreader from 3 points (mesial, buccal, and distal) and an electronic caliper during surgery. | Procedure or surgery | subepithelial |
| de- epithelize gingival graftThe area where the gingival recession occurred was prepared with the modified coronally positioned flap technique developed by Zuchelli. A shallow horizontal incision was made at ≈3 mm apical from the gingival margin of the maxillary molar teeth using a number 15 scalpel blade. Subsequently, a parallel horizontal incision, at ≈ 4 mm apical from the first horizontal incision, was traced in conjunction with two vertical releasing incisions to delineate a rectangular area. Then, the uppermost epithelial layer was scraped off using a size 11 scalpel tip. The connective tissue graft to be taken from the palate area was 10x5x2 mm in size, and the graft thickness was measured with an endodontic spreader from 3 points (mesial, buccal, and distal) and electronic caliper during surgery. | Procedure or surgery | de-epithelise |
| ultrasonographyClinical parameter measurements (probing depth (PD), clinical attachment level (CAL), gingival recession depth and width, keratinized tissue width and height) were taken on the day of surgery, the 3rd days, the 14th days, the 1st month, the 3rd months and the 6th months. Ultrasonography measurements A 6-18 MHz intraoral probe was used in intraoral USG examinations. Sterile gel was applied to the intraoral probe and covered with a stretch film. Then, it was placed directly on the mucosal surface of the receiver site in the buccal area. Mucosal thickness was evaluated using the B-mode of the device, and vascularization was evaluated using the color doppler and pulsed wave doppler modes of the device. The following equation is used and calculated by US unit pulsatility index (PI) = (Vmax-Vmin) (Vmean) (Vmax is peak systolic flow velocity. Vmin is diastolic flow velocity and Vmean is mean flow velocity.) The mean PI values of each patient were measured. | Diagnostic test | de-epithelise, subepithelial |
Primary outcome
tissue thickness
Time frame: at baseline before operation, on days 3,14, 30, 90,180
tissue thickness was measured with B-Mod mod of ultrasonography device
1 secondary outcome
pulsatility index
Time frame: at baseline before operation, on days 3,14,30,90,180
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 23 Apr 2024.
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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.
GİZEM TORUMTAY CİN, assist prof. principal investigator
PAMUKKALE UNIVERSITY FACULTY of DENTISTIRY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subepithelial connective tissue graft, de- epithelize gingival graft and ultrasonography in people with Gingival Recession, Localized, run by Pamukkale 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 6 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 23 Apr 2024. 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?
tissue thickness (time frame: at baseline before operation, on days 3,14, 30, 90,180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2024.