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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720707
• Other study ID #: 841
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2008
• Last updated: July 22, 2008
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: July 2008
• Source: Tabriz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Dentistry- Tabriz University of Medical Sciences	Tabriz	East Azerbaijan

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of root coverage		at baseline, 2 and 6 months after treatment.	Yes
Secondary	clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures		6 months after treatment	Yes