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

NCT ID: NCT02916186

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Acellular Dermal Matrix

Intervention Type BIOLOGICAL

Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.

Tunnel technique with the subepithelial connective tissue graft

Intervention Type PROCEDURE

Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate

subepithelial connective tissue graft

Tunnel is prepared and sub-epithelial connective tissue graft is harvested from the palate and placed under the flap.

Group Type ACTIVE_COMPARATOR

Acellular Dermal Matrix

Intervention Type BIOLOGICAL

Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.

Tunnel technique with the subepithelial connective tissue graft

Intervention Type PROCEDURE

Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate

Interventions

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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.

Intervention Type BIOLOGICAL

Tunnel technique with the subepithelial connective tissue graft

Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate

Intervention Type PROCEDURE

Other Intervention Names

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Puros Dermis Allograft Tissue Matrix autogenous connective tissue graft

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Fatema Mohammed Ali Elmahdi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CEBD-CU-2016-09-197

Identifier Type: -

Identifier Source: org_study_id

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