Clinical trial NCT05923294: Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions
Official title: Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Localized
Sensitivity, Tooth
Attachment Loss, Periodontal
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare the root coverage rate of the gingival unit-shaped connective tissue graft, obtained by intraoral de-epithelization, with the traditional de-epithelialized free gingival graft in localized recessions of anterior and premolar teeth. In addition, it is aimed to compare the postoperative gingival thickness between the two techniques. The secondary aim is to search the effects of both techniques on periodontal parameters and to evaluate patient-centered outcomes.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists physical status class 1 and 2 patients,healthy patients
2. Nonsmokers
3. Periodontally healthy patients
4. Localized gingival recessions (Miller I, II, and Cairo I recessions with a depth of recession of at least 2 mm) in anterior and premolar teeth

Exclusion Criteria:

1. Medically compromised patients, especially uncontrolled diabetes
2. Pregnancy, lactation, or suspicion of pregnancy,
3. Poor oral hygiene
4. Recessions associated with caries or restoration

Primary outcomes:
measure: Root coverage percentage
timeFrame: Postoperative 6th month
measure: Gingival thickness
timeFrame: Preoperative and postoperative 6th month
Secondary outcomes:
measure: Recession width
timeFrame: Preoperative and postoperative 6th month
measure: Probing depth
timeFrame: Preoperative and postoperative 6th month
measure: Clinical attachment loss
timeFrame: Preoperative and postoperative 6th month
measure: Keratinized gingiva width
timeFrame: Preoperative and postoperative 6th month
measure: Vestibular depth
timeFrame: Preoperative and postoperative 6th month
measure: Pain perception
timeFrame: Postoperative 1st week
measure: Bleeding related to the procedure
timeFrame: Postoperative 1st week
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References:
citation: Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.
citation: Mythri S, Arunkumar SM, Hegde S, Rajesh SK, Munaz M, Ashwin D. Etiology and occurrence of gingival recession - An epidemiological study. J Indian Soc Periodontol. 2015 Nov-Dec;19(6):671-5. doi: 10.4103/0972-124X.156881.
citation: Kassab MM, Badawi H, Dentino AR. Treatment of gingival recession. Dent Clin North Am. 2010 Jan;54(1):129-40. doi: 10.1016/j.cden.2009.08.009.
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: Zucchelli G, Tavelli L, Barootchi S, Stefanini M, Rasperini G, Valles C, Nart J, Wang HL. The influence of tooth location on the outcomes of multiple adjacent gingival recessions treated with coronally advanced flap: A multicenter re-analysis study. J Periodontol. 2019 Nov;90(11):1244-1251. doi: 10.1002/JPER.18-0732. Epub 2019 Jul 1.
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: Sriwil M, Fakher MAA, Hasan K, Kasem T, Shwaiki T, Wassouf G. Comparison of Free Gingival Graft and Gingival Unit Graft for Treatment of Gingival Recession: A Randomized Controlled Trial. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e103-e110. doi: 10.11607/prd.4180.