Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage

NCT ID: NCT00720707

Last Updated: 2008-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-03-31

Brief Summary

The aim of this study is to compare the clinical outcomes of root coverage procedures, using coronally advanced flap in combination with acellular dermal matrix with or without enamel matrix derivatives .

Detailed Description

coverage of gingival recession defects has been considered as a matter of interest for dental practitioners.subjects with a paired gingival recession defect will be selected from the patients who sought dental treatment at our department.Random allocation of the treatment sites to test (CAF+ EMD+ADM) and control (CAF + ADM) groups will be performed by a person who is external to the study and using a computerized selection of random numbers for allocation of the study groups.The parameters of the study are as following items: probing depth( PD), clinical attachment level (CAL), width of keratinized tissue (WKT), recession depth from cemento- enamel junction (RD), recession width (RW), distance between mucogingival junction and the stent (MGJ), Plaque (PI) and gingival (GI) indices and root coverage percentage (RC) and the patients will be followed up for 6 months.

Conditions

Gingival Recession

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

(CAF+ADM+EMD)

using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).

Group Type: EXPERIMENTAL

CAF+ADM+EMD

Intervention Type: PROCEDURE

using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).

(CAF + ADM)

root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)

Group Type: ACTIVE_COMPARATOR

CAF+ADM

Intervention Type: PROCEDURE

using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.

Interventions

CAF+ADM+EMD

using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).

Intervention Type: PROCEDURE

CAF+ADM

using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.

Intervention Type: PROCEDURE

Other Intervention Names

Alloderm®; Emdogain®; Alloderm®; Emdogain®

Eligibility Criteria

Inclusion Criteria

• Having no systemic disease affecting the periodontium,
• No contraindication for elective surgery,
• Adequate oral hygiene ,
• No previous surgical attempts for root coverage at the studying sites,
• Vital teeth and signing a witness letter.

Exclusion Criteria

• Smoking, presence of a restorations on tooth surface for test and control teeth,
• Pregnancy,
• Being under treatment with steroids,
• Peri-apical infection,
• Indication for antibiotic prophylaxis prior to dental treatments

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tabriz University

OTHER

Sponsor Role: lead

Responsible Party

Tabriz University of Medical Sciences

Principal Investigators

Reza Pourabbas, DDS

Role: PRINCIPAL_INVESTIGATOR

Tabriz University (Medical Sciences)

Locations

Faculty of Dentistry- Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, Iran

Countries

Iran

Other Identifiers

841

Identifier Type: -

Identifier Source: org_study_id