Clinical trial NCT04637451: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Periodontal Diseases
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Gingival Recession Depth at 6 month
timeFrame: Baseline and month 6.
measure: Change from Baseline Keratinized Gingiva Height at 6 month
timeFrame: Baseline and month 6.
Secondary outcomes:
measure: Change from Baseline Root Hypersensitivity at 6 month
timeFrame: Baseline and month 6.
measure: Change from Baseline Patient Satisfaction at 6 month
timeFrame: Baseline and month 6.
measure: Change from Baseline Pain at 1 week
timeFrame: Baseline and week 1.
measure: Change from Baseline Pain at 2 week
timeFrame: Baseline and week 2.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sibel Kayaaltı Yüksek
state: Tuzla
Study officials:
References:
citation: Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.
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.
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.
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.
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.
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.
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.
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.
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.