The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage
1 other identifier
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2016
CompletedFirst Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 19, 2020
CompletedNovember 19, 2020
November 1, 2020
1 year
November 10, 2020
November 18, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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)
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)
Baseline and month 6.
Secondary Outcomes (4)
Change from Baseline Root Hypersensitivity at 6 month
Baseline and month 6.
Change from Baseline Patient Satisfaction at 6 month
Baseline and month 6.
Change from Baseline Pain at 1 week
Baseline and week 1.
Change from Baseline Pain at 2 week
Baseline and week 2.
Study Arms (2)
Gingival Unit Graft
EXPERIMENTALFor test group, gingival recessions were treated with gingival unit graft.
Connective Tissue Graft
OTHERFor Control group, gingival recessions were treated with connective tissue graft.
Interventions
Gingival unit graft Connective tissue graft
Eligibility Criteria
You may qualify if:
- Systemic healthy individuals
- Presence Miller's class I and II gingival recession in the anterior and premolar teeth
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Okan Universitylead
Study Sites (1)
Sibel Kayaaltı Yüksek
Istanbul, Tuzla, 34852, Turkey (Türkiye)
Related Publications (9)
Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.
PMID: 25867992BACKGROUNDCairo 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.
PMID: 27454460BACKGROUNDAllen 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.
PMID: 15119887BACKGROUNDKuru 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.
PMID: 22390550BACKGROUNDYildirim 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.
PMID: 25685769BACKGROUNDDel 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.
PMID: 12423299BACKGROUNDDouglas 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.
PMID: 22548583BACKGROUNDCamargo 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.
PMID: 11551301BACKGROUNDKayaalti-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.
PMID: 34787718DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 19, 2020
Study Start
July 1, 2015
Primary Completion
July 15, 2016
Study Completion
July 30, 2016
Last Updated
November 19, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share