Gingival RecessionNCT04637451
The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage
A study testing Root coverage treatment in people with Gingival Recession and Periodontal Diseases, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Periodontal Diseases
- What is being tested?
- Root coverage treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2015to 30 Jul 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemic healthy individuals
- Presence Miller's class I and II gingival recession in the anterior and premolar teeth
Who cannot join
- Age <18 years
- Pregnancy
- Lactation
- Any cardiovascular, renal or hepatic conditions
- History of periodontal surgery
- Tooth mobility
- Presence of probing depth >3 mm and caries or restorations in the teeth undergoing treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial
The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.
Read the detailed description
Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.
- Conditions
- Gingival Recession, Periodontal Diseases
- Being tested
- Root coverage treatment
- Medical subject headings
- Gingival Recession, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root coverage treatmentProcedure or surgery
Gingival unit graft Connective tissue graft
| Study group | Role | What they receive |
|---|---|---|
| Gingival Unit Graft | Experimental | For test group, gingival recessions were treated with gingival unit graft. Receives: Procedure: Root coverage treatment |
| Connective Tissue Graft | Other | For Control group, gingival recessions were treated with connective tissue graft. Receives: Procedure: Root coverage treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Gingival Recession Depth at 6 month
The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
Measured: Baseline and month 6.
Change from Baseline Keratinized Gingiva Height at 6 month
Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
Measured: Baseline and month 6.
Secondary outcomes (4)
Change from Baseline Root Hypersensitivity at 6 month
Root hypersensitivity at baseline and post-operative 6 month utilizing a visual numerical scale (VNS) test are defined. Possible scores range from (0=no sensitive and 10= worst possible sensitive). Change= (6 month score-baseline score)
Measured: Baseline and month 6.
Change from Baseline Patient Satisfaction at 6 month
The patient satisfaction with the gingiva position, structure and color of the gingival recessions sites utilizing a VNS test (0=not satisfied and 10=very satisfied) are defined. Possible scores range from 0 (not satisfied) to 10 (very satisfied). Change= (6 month score-baseline score)
Measured: Baseline and month 6.
Change from Baseline Pain at 1 week
Pain perception of the surgery at intra and post-operative period (week 1) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (1 week score-baseline score)
Measured: Baseline and week 1.
Change from Baseline Pain at 2 week
Pain perception of the surgery at intra and post-operative period (week 2) utilizing a VNS test are defined. Possible scores range from 0 (no pain) to 10 (worst possible pain). Change= (2 week score-baseline score)
Measured: Baseline and week 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jul 2015
- Primary completion15 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Kayaalti-Yuksek, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637451
- Sponsor's protocol ID
- 2015/174
- Status last verified
- Nov 2020
- First submitted
- 10 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.
PubMed 25867992Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.
PubMed 27454460Allen AL. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Int J Periodontics Restorative Dent. 2004 Apr;24(2):165-75.
PubMed 15119887Kuru B, Yildirim S. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial. J Periodontol. 2013 Jan;84(1):41-50. doi: 10.1902/jop.2012.110685. Epub 2012 Mar 5.
PubMed 22390550Yildirim S, Kuru B. Gingival unit transfer using in the Miller III recession defect treatment. World J Clin Cases. 2015 Feb 16;3(2):199-203. doi: 10.12998/wjcc.v3.i2.199.
PubMed 25685769Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
PubMed 12423299Douglas de Oliveira DW, Oliveira-Ferreira F, Flecha OD, Goncalves PF. Is surgical root coverage effective for the treatment of cervical dentin hypersensitivity? A systematic review. J Periodontol. 2013 Mar;84(3):295-306. doi: 10.1902/jop.2012.120143. Epub 2012 May 1.
PubMed 22548583Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.
PubMed 11551301Kayaalti-Yuksek S, Yaprak E. The comparison of the efficacy of gingival unit graft with connective tissue graft in recession defect coverage: a randomized split-mouth clinical trial. Clin Oral Investig. 2022 Mar;26(3):2761-2770. doi: 10.1007/s00784-021-04252-5. Epub 2021 Nov 17.
PubMed 34787718
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT04637451
- Acronym / sponsor ID
- 2015/174
- Conditions
- Gingival Recession, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 19 Nov 2020 (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.
The purpose of the study is to compare the clinical effectiveness of gingival unit graft (GUG) and connective tissues graft (CTG) in Miller's class I and II gingival recession.
Detailed description
Patients who accept the study have provided information about the study and required a written informed consent form. The clinical effectiveness of two different periodontal surgical techniques (gingival unit graft and connective tissue graft) in gingival recessions will be evaluated. Periodontal measurements (gingival recession, keratinized gingiva height) and patient-reported outcomes (intra and post-operative pain, patient satisfaction and hypersensitivity) are defined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gingival Unit Graft | Experimental | Procedure: Root coverage treatmentFor test group, gingival recessions were treated with gingival unit graft. |
| Connective Tissue Graft | Other | Procedure: Root coverage treatmentFor Control group, gingival recessions were treated with connective tissue graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemic healthy individuals
- Presence Miller's class I and II gingival recession in the anterior and premolar teeth
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnancy
- Lactation
- Any cardiovascular, renal or hepatic conditions
- 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 |
|---|---|---|
| Root coverage treatmentGingival unit graft Connective tissue graft | Procedure or surgery | Connective Tissue Graft, Gingival Unit Graft |
Primary outcome
Change from Baseline Gingival Recession Depth at 6 month
Time frame: Baseline and month 6.
The gingival recession depth consists of the distance from the cement-enamel junction to the most apical extension of the gingival margin. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
Change from Baseline Keratinized Gingiva Height at 6 month
Time frame: Baseline and month 6.
Keratinized gingiva height, measured as the distance from the gingival margin to the mucogingival line. The measurement is recorded in millimeters. Change= (6 month score-baseline score)
4 secondary outcomes
Change from Baseline Root Hypersensitivity at 6 month
Time frame: Baseline and month 6.
Change from Baseline Patient Satisfaction at 6 month
Time frame: Baseline and month 6.
Change from Baseline Pain at 1 week
Time frame: Baseline and week 1.
Change from Baseline Pain at 2 week
Time frame: Baseline and week 2.
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 19 Nov 2020.
- Background: PubMed 25867992Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.
- Background: PubMed 27454460Cairo F, Pagliaro U, Buti J, Baccini M, Graziani F, Tonelli P, Pagavino G, Tonetti MS. Root coverage procedures improve patient aesthetics. A systematic review and Bayesian network meta-analysis. J Clin Periodontol. 2016 Nov;43(11):965-975. doi: 10.1111/jcpe.12603. Epub 2016 Sep 16.
- Background: PubMed 15119887Allen AL. Use of the gingival unit transfer in soft tissue grafting: report of three cases. Int J Periodontics Restorative Dent. 2004 Apr;24(2):165-75.
- Background: PubMed 22390550Kuru B, Yildirim S. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial. J Periodontol. 2013 Jan;84(1):41-50. doi: 10.1902/jop.2012.110685. Epub 2012 Mar 5.
- Background: PubMed 25685769Yildirim S, Kuru B. Gingival unit transfer using in the Miller III recession defect treatment. World J Clin Cases. 2015 Feb 16;3(2):199-203. doi: 10.12998/wjcc.v3.i2.199.
- Background: PubMed 12423299Del Pizzo M, Modica F, Bethaz N, Priotto P, Romagnoli R. The connective tissue graft: a comparative clinical evaluation of wound healing at the palatal donor site. A preliminary study. J Clin Periodontol. 2002 Sep;29(9):848-54. doi: 10.1034/j.1600-051x.2002.290910.x.
- Background: PubMed 22548583Douglas de Oliveira DW, Oliveira-Ferreira F, Flecha OD, Goncalves PF. Is surgical root coverage effective for the treatment of cervical dentin hypersensitivity? A systematic review. J Periodontol. 2013 Mar;84(3):295-306. doi: 10.1902/jop.2012.120143. Epub 2012 May 1.
- Background: PubMed 11551301Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. doi: 10.1034/j.1600-0757.2001.027001072.x. No abstract available.
- Derived from this study: PubMed 34787718Kayaalti-Yuksek S, Yaprak E. The comparison of the efficacy of gingival unit graft with connective tissue graft in recession defect coverage: a randomized split-mouth clinical trial. Clin Oral Investig. 2022 Mar;26(3):2761-2770. doi: 10.1007/s00784-021-04252-5. Epub 2021 Nov 17.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Root coverage treatment in people with Gingival Recession and Periodontal Diseases, run by Okan 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 2 inclusion and 7 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 19 Nov 2020. 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?
Change from Baseline Gingival Recession Depth at 6 month (time frame: Baseline and month 6.). 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 NCT04637451, which also lists 9 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 19 Nov 2020.