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

July 22, 2008 updated by: Tabriz University

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • East Azerbaijan
      • Tabriz, East Azerbaijan, Iran, Islamic Republic of, 51664
        • Faculty of Dentistry- Tabriz University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage of root coverage
Time Frame: at baseline, 2 and 6 months after treatment.
at baseline, 2 and 6 months after treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures
Time Frame: 6 months after treatment
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabriz University

Investigators

  • Principal Investigator: Reza Pourabbas, DDS, Tabriz University (Medical Sciences)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 22, 2008

First Submitted That Met QC Criteria

July 22, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 23, 2008

Last Update Submitted That Met QC Criteria

July 22, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 841

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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