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

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ClinicalTrials.gov Identifier: NCT00720707
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : July 23, 2008
Sponsor:
Information provided by:
Tabriz University

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 Type : Interventional  (Clinical Trial)
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 : April 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2007

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®




Primary Outcome Measures :
  1. the percentage of root coverage [ Time Frame: at baseline, 2 and 6 months after treatment. ]

Secondary Outcome Measures :
  1. clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures [ Time Frame: 6 months after treatment ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Responsible Party: Dr. Reza Pourabbas, Tabriz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00720707     History of Changes
Other Study ID Numbers: 841
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: July 23, 2008
Last Verified: July 2008

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
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy