Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions

Evaluation of Subepithelial Connective Tissue Graft Versus Acellular Dermal Matrix With Tunnel Technique in Treatment of Multiple Gingival Recessions (Randomized Clinical Trial, Parallel Design)

The goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.

Study Overview

• Status: Unknown
• Conditions: Gingival Recession
• Intervention / Treatment: Biological: Acellular Dermal Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft

Detailed Description

Acellular dermal matrix with Tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, Post-Operative pain and root coverage, clinical attachment level, width of Keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with Tunnel technique.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects with facial multiple gingival recession defects classified as either class I or II defects according to Miller's classification (Miller 1985).
• Subjects aged between 18 - 60 years old.
• Patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome.
• Patients with good oral hygiene.

Exclusion Criteria:

• Current and former smokers.
• Pregnant females.
• Subjects received any periodontal therapy for minimum of 6 months prior to the study.
• Subjects taking drugs known to interfere with wound healing.
• Subjects with unacceptable oral hygiene with plaque index >2.
• Teeth with non-carious cervical lesions (NCCL), cervical caries and malalignment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tunnel technique with acellular dermal matrix; the tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface.	Biological: Acellular Dermal Matrix; Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.; Other Names: Puros Dermis Allograft Tissue Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft; Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate; Other Names: autogenous connective tissue graft
Active Comparator: subepithelial connective tissue graft; Tunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap.	Biological: Acellular Dermal Matrix; Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.; Other Names: Puros Dermis Allograft Tissue Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft; Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate; Other Names: autogenous connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient Satisfaction .	measured by VAS scale	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
root coverage	measured by periodontal probe	1 year
Clinical Attachment Level	measured by periodontal probe	1 year
Width of Keratinized Tissue	measured by periodontal probe	1 year
Gingival Bio-type	measured by endodontics file	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: CEBD-CU-2016-09-197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED