Back to resultsThe Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage
Primary Purpose
Gingival Recession, Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Root coverage treatment
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- Systemic healthy individuals
- Presence Miller's class I and II gingival recession in the anterior and premolar teeth
Exclusion Criteria:
- 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
Sites / Locations
- Sibel Kayaaltı Yüksek
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Gingival Unit Graft
Connective Tissue Graft
Arm Description
For test group, gingival recessions were treated with gingival unit graft.
For Control group, gingival recessions were treated with connective tissue graft.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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)
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04637451
Brief Title
The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage
Official Title
The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
July 15, 2016 (Actual)
Study Completion Date
July 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession, Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gingival Unit Graft
Arm Type
Experimental
Arm Description
For test group, gingival recessions were treated with gingival unit graft.
Arm Title
Connective Tissue Graft
Arm Type
Other
Arm Description
For Control group, gingival recessions were treated with connective tissue graft.
Intervention Type
Procedure
Intervention Name(s)
Root coverage treatment
Intervention Description
Gingival unit graft Connective tissue graft
Primary Outcome Measure Information:
Title
Change from Baseline Gingival Recession Depth at 6 month
Description
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)
Time Frame
Baseline and month 6.
Title
Change from Baseline Keratinized Gingiva Height at 6 month
Description
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)
Time Frame
Baseline and month 6.
Secondary Outcome Measure Information:
Title
Change from Baseline Root Hypersensitivity at 6 month
Description
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)
Time Frame
Baseline and month 6.
Title
Change from Baseline Patient Satisfaction at 6 month
Description
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)
Time Frame
Baseline and month 6.
Title
Change from Baseline Pain at 1 week
Description
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)
Time Frame
Baseline and week 1.
Title
Change from Baseline Pain at 2 week
Description
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)
Time Frame
Baseline and week 2.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemic healthy individuals
Presence Miller's class I and II gingival recession in the anterior and premolar teeth
Exclusion Criteria:
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
Facility Information:
Facility Name
Sibel Kayaaltı Yüksek
City
Istanbul
State/Province
Tuzla
ZIP/Postal Code
34852
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25867992
Citation
Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.
Results Reference
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PubMed Identifier
27454460
Citation
Cairo 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.
Results Reference
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PubMed Identifier
15119887
Citation
Allen 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.
Results Reference
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PubMed Identifier
22390550
Citation
Kuru 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.
Results Reference
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PubMed Identifier
25685769
Citation
Yildirim 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.
Results Reference
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PubMed Identifier
12423299
Citation
Del 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.
Results Reference
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PubMed Identifier
22548583
Citation
Douglas 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.
Results Reference
background
PubMed Identifier
11551301
Citation
Camargo 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.
Results Reference
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PubMed Identifier
34787718
Citation
Kayaalti-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.
Results Reference
derived
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The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage
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