Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

Gingival Recession, Localized Clinical Trial

Official title:

Clinical Comparison of Two Different Graft Harvesting Techniques Applied in Localized Gingival Recessions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923294
• Other study ID #: 0043
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: July 3, 2024

Study information

• Verified date: July 2023
• Source: Kutahya Health Sciences University
• Contact: Ezgi Gürbüz, DDS PhD
• Phone: +905557411860
• Email: ezgi.dogan[@]ksbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 3, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Attachment Loss, Periodontal
• Dentin Sensitivity
• Gingival Recession
• Gingival Recession, Localized
• Periodontal Attachment Loss
• Sensitivity, Tooth

Intervention

Procedure:
• Coronally advanced flap with connective tissue graft
In both groups, connective tissue graft with a trapezoidal flap design will be applied to the recession area.

Locations

Country	Name	City	State
Turkey	Kutahya Health Sciences University	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences 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

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. — View 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. — 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

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root coverage percentage	The comparison of the postoperative recession depth to the initial recession depth	Postoperative 6th month
Primary	Gingival thickness	Gingival thickness in the mid-buccal of the recession defect measured with an endodontic spreader and digital recordings	Preoperative and postoperative 6th month
Secondary	Recession width	Recession width measured at the cemento-enamel junction	Preoperative and postoperative 6th month
Secondary	Probing depth	Probing depth measured at the mid-buccal of the recession defect	Preoperative and postoperative 6th month
Secondary	Clinical attachment loss	Clinical attachment loss measured at the mid-buccal of the recession defect	Preoperative and postoperative 6th month
Secondary	Keratinized gingiva width	Mid-buccal gingival width measured with a periodontal probe	Preoperative and postoperative 6th month
Secondary	Vestibular depth	The distance from the gingival margin to the greatest concavity of the mucosal fold	Preoperative and postoperative 6th month
Secondary	Pain perception	Visual analog scale where higher scores mean a worse outcome and has a minimum value of 0 and a maximum value of 10	Postoperative 1st week
Secondary	Bleeding related to the procedure	Bleeding evaluated by a dichotomous index	Postoperative 1st week