The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage

Periodontal Diseases Clinical Trial

Official title:

The Comparison of the Efficacy of Gingival Unit Graft With Connective Tissue Graft in Root Coverage: A Randomized Split-Mouth Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04637451
• Other study ID #: 2015/174
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: July 30, 2016

Study information

• Verified date: November 2020
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 30, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Periodontal Diseases

Intervention

Procedure:
• Root coverage treatment
Gingival unit graft Connective tissue graft

Locations

Country	Name	City	State
Turkey	Sibel Kayaalti Yüksek	Istanbul	Tuzla

Sponsors (1)

Lead Sponsor	Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. — View 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. — View Citation

Camargo PM, Melnick PR, Kenney EB. The use of free gingival grafts for aesthetic purposes. Periodontol 2000. 2001;27:72-96. Review. — View 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. — View Citation

Douglas de Oliveira DW, Oliveira-Ferreira F, Flecha OD, Gonçalves 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. Review. — View 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. — View 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. — View Citation

Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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)	Baseline and month 6.
Secondary	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)	Baseline and month 6.
Secondary	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)	Baseline and week 1.
Secondary	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)	Baseline and week 2.