Coronally Advanced Flap in Combination With Acellular Dermal Matrix and Enamel Matrix Derivatives for Root Coverage
1 other identifier
interventional
18
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 22, 2008
CompletedFirst Posted
Study publicly available on registry
July 23, 2008
CompletedJuly 23, 2008
July 1, 2008
10 months
July 22, 2008
July 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the percentage of root coverage
at baseline, 2 and 6 months after treatment.
Secondary Outcomes (1)
clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures
6 months after treatment
Study Arms (2)
(CAF+ADM+EMD)
EXPERIMENTALusing coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).
(CAF + ADM)
ACTIVE COMPARATORroot coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)
Interventions
using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).
using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) without enamel matrix derivatives (EMD) for root coverage procedures.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry- Tabriz University of Medical Sciences
Tabriz, East Azerbaijan Province, 51664, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reza Pourabbas, DDS
Tabriz University (Medical Sciences)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 22, 2008
First Posted
July 23, 2008
Study Start
April 1, 2006
Primary Completion
February 1, 2007
Study Completion
March 1, 2007
Last Updated
July 23, 2008
Record last verified: 2008-07