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

Tracking Information

First Received Date ^ICMJE

July 22, 2008

Last Updated Date

July 22, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 .

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Gingival Recession

Intervention ^ICMJE

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®
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®

Study Arm (s)

Experimental: (CAF+ADM+EMD)
using coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM) with enamel matrix derivatives (EMD).

Intervention: Procedure: CAF+ADM+EMD
Active Comparator: (CAF + ADM)
root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)

Intervention: Procedure: CAF+ADM

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT00720707

Other Study ID Numbers ^ICMJE

841

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Reza Pourabbas, Tabriz University of Medical Sciences

Study Sponsor ^ICMJE

Tabriz University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Reza Pourabbas, DDS

Tabriz University (Medical Sciences)

Information Provided By

Tabriz University

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top