Comparing Deepithelialized Free Gingival Graft Versus Subpithelial Connective Tissue Graft With Tunneling Technique in Treating RT2 Gingival Recession

The Effect of the Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Deepithelialized Free Gingival Graft on the Papillary Height in the Treatment of RT2 Recession Defect: a Randomized Clinical Trial.

Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures.

According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1 (Miller Class I and II) defects and that further research on results in RT-2, RT-3 ( Miller Class III and IV) defects is needed. Consequently, it was planned to conduct this research on RT-2 (Miller Class III) recessions to overcome this gap of knowledge, de-epithelialized free gingival graft is proposed aiming to enhance the papillary height, esthetic, with less pain and postoperative trauma. Equally, it is considered a more conservative approach with fewer complications.

Study Overview

• Status: Unknown
• Conditions: RT2 Gingival Recession
• Intervention / Treatment: Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.

Detailed Description

Gingival recession has high prevalence among both individuals with periodontal disease and those with high standers of oral hygiene. The management of RT-2 ( Miller Class III) gingival recessions is very challenging and there is controversy in the literature concerning the most predictable approach to treat these defects.

Treatment of gingival recession is performed to enhance esthetics, reduce dentinal hypersensitivity, eliminate caries risk, stop the progression of gingival recession and periodontal attachment loss and keratinized tissue augmentation to enable the patient to maintain adequate plaque control.Gingival recession or "Marginal tissue recession" is recognized as the apical migration of the marginal gingiva to its normal position on the root surface. Connective tissue graft (CTG) is considered to be the best root coverage techniques for the treatment of gingival recession defects.

However, it is challenging sometimes to harvest the largest volume of tissue especially in thin palatal tissue as recently it was recommended to keep 2mm of soft tissue thickness covering the palate to minimize the postoperative pain. Otherwise, necrosis/dehiscence of the flap may happen which was reported to occur frequently for the trap-door approach. Moreover, it is necessary to extend the dissection deeper into the palatal tissues to leave adequate thickness of connective tissue to maintain the vitality of the primary flap which may cause more painful post-operative course.

To overcome these limitations, CTG harvesting with de-epithelialized gingival grafts (DGG) can be executed even in the presence of thin palatal tissues. CTG preparation can be performed more superficially by this approach to obtain collagen-rich connective tissue from Lamina pro- pria of the palatal mucosa. The findings of Zucchelli et al. study support the observation that CTGs which are presumed to have denser connective tissue are comparatively less prone to post-operative shrinkage . According to this assumption, DGG technique may enable to harvest an adequate amount of dense and stable tissue

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: sarah Elshourbagy, MSC; Phone Number: 01288624000; Email: sara_elshourbagy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site

Exclusion Criteria:

Pregnant females. Smokers as smoking is a contraindication for any plastic periodontal surgery Unmotivated, uncooperative patients with poor oral hygiene. Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Overlapping teeth or teeth with abnormal alignment in the dental arch.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: deepithelializ free gingival graft; performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession	Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.; enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.; Other Names: root coverage
Active Comparator: subepithelial connective tissue graft; performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession	Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.; enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.; Other Names: root coverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the distance between the contact point and the top of the papilla	measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe	9 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hani ElNahass, PHD, Cairo University

Publications and helpful links

General Publications

• Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 10, 2019
• Primary Completion (Anticipated): July 10, 2020
• Study Completion (Anticipated): April 10, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: tunneling technique, gingival recession, deepithelialized free gingival graft, sub epithelial connective tissue graft,
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: perio 331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: I will check with my study chair

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No