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

NCT02916186 | Unknown DMC

• 1 other identifier: CEBD-CU-2016-09-197
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• patient Satisfaction .

  measured by VAS scale

  1 year

Secondary Outcomes (4)

• root coverage

  1 year

• Clinical Attachment Level

  1 year

• Width of Keratinized Tissue

  1 year

• Gingival Bio-type

  1 year

Study Arms (2)

Tunnel technique with acellular dermal matrix

EXPERIMENTAL

the tunnel technique involves separation of the gingiva, then acellular dermal matrix interposed between the flap and the root surface.

Biological: Acellular Dermal Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft

subepithelial connective tissue graft

ACTIVE COMPARATOR

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

Biological: Acellular Dermal Matrix; Procedure: Tunnel technique with the subepithelial connective tissue graft

Interventions

Acellular Dermal Matrix 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.

Also known as: Puros Dermis Allograft Tissue Matrix

Tunnel technique with acellular dermal matrix; subepithelial connective tissue graft

Tunnel technique with the subepithelial connective tissue graft PROCEDURE

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

Also known as: autogenous connective tissue graft

Tunnel technique with acellular dermal matrix; subepithelial connective tissue graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 27, 2016
• Study Start: October 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-09