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

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00720707
First received: July 22, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

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 Intervention Phase
Gingival Recession
Procedure: CAF+ADM+EMD
Procedure: CAF+ADM
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • the percentage of root coverage [ Time Frame: at baseline, 2 and 6 months after treatment. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: April 2006
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720707

Locations
Iran, Islamic Republic of
Faculty of Dentistry- Tabriz University of Medical Sciences
Tabriz, East Azerbaijan, Iran, Islamic Republic of, 51664
Sponsors and Collaborators
Tabriz University
Investigators
Principal Investigator: Reza Pourabbas, DDS Tabriz University (Medical Sciences)
  More Information

No publications provided

Responsible Party: Dr. Reza Pourabbas, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00720707     History of Changes
Other Study ID Numbers: 841
Study First Received: July 22, 2008
Last Updated: July 22, 2008
Health Authority: Iran: Ministry of Health

Keywords provided by Tabriz University:
Coronally advanced flap
gingival recession
enamel matrix protein
acellular dermal matrix
root coverage

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Mouth Diseases
Periodontal Atrophy
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014