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

Sponsor

Tabriz University (Other)

Overall Status

Completed

CT.gov ID

NCT00720707

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Procedure: CAF+ADM+EMD Procedure: CAF+ADM	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Coronally Advanced Flap in Combination With Acellular Dermal Matrix With or Without Enamel Matrix Derivatives for Root Coverage

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (CAF+ADM+EMD) using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).	Procedure: CAF+ADM+EMD using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD). Other Names: Alloderm® Emdogain®
Active Comparator: (CAF + ADM) root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)	Procedure: CAF+ADM using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures. Other Names: Alloderm® Emdogain®

Arm

Intervention/Treatment

Experimental: (CAF+ADM+EMD)

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

Procedure: CAF+ADM+EMD

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

Other Names:

Alloderm®

Emdogain®

Active Comparator: (CAF + ADM)

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

Procedure: CAF+ADM

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

Other Names:

Alloderm®

Emdogain®

Outcome Measures

Primary Outcome Measures

the percentage of root coverage [at baseline, 2 and 6 months after treatment.]

Secondary Outcome Measures

clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures [6 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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