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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02916186
• Other study ID #: CEBD-CU-2016-09-197
• Status: Not yet recruiting
• Phase: N/A
• First received: September 21, 2016
• Last updated: September 26, 2016
• Start date: October 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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.

Procedure:
• Tunnel technique with the subepithelial connective tissue graft
Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient Satisfaction .	measured by VAS scale	1 year	Yes
Secondary	root coverage	measured by periodontal probe	1 year	Yes
Secondary	Clinical Attachment Level	measured by periodontal probe	1 year	Yes
Secondary	Width of Keratinized Tissue	measured by periodontal probe	1 year	Yes
Secondary	Gingival Bio-type	measured by endodontics file	1 year	Yes