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

Primary Purpose

Gingival Recession

Status

Completed

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

CAF+ADM+EMD

CAF+ADM

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Coronally advanced flap, gingival recession, enamel matrix protein, acellular dermal matrix, root coverage

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Dentistry- Tabriz University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(CAF+ADM+EMD)

(CAF + ADM)

Arm Description

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

root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)

Outcomes

Primary Outcome Measures

the percentage of root coverage

Secondary Outcome Measures

clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures

Full Information

NCT ID

NCT00720707

First Posted

July 22, 2008

Last Updated

July 22, 2008

Sponsor

Tabriz University

1. Study Identification

Unique Protocol Identification Number

NCT00720707

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

February 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Tabriz University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingival Recession

Keywords

Coronally advanced flap, gingival recession, enamel matrix protein, acellular dermal matrix, root coverage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

(CAF+ADM+EMD)

Arm Type

Experimental

Arm Description

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

Arm Title

(CAF + ADM)

Arm Type

Active Comparator

Arm Description

root coverage procedure by using a coronally advanced flap (CAF) in combination with acellular dermal matrix (ADM)

Intervention Type

Procedure

Intervention Name(s)

CAF+ADM+EMD

Other Intervention Name(s)

Alloderm®, Emdogain®

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

CAF+ADM

Other Intervention Name(s)

Alloderm®, Emdogain®

Intervention Description

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

Primary Outcome Measure Information:

Title

the percentage of root coverage

Time Frame

at baseline, 2 and 6 months after treatment.

Secondary Outcome Measure Information:

Title

clinical attachment level, width of keratinized gingiva ant the position of mucco-gingival junction following root coverage procedures

Time Frame

6 months after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reza Pourabbas, DDS

Organizational Affiliation

Tabriz University (Medical Sciences)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry- Tabriz University of Medical Sciences

City

Tabriz

State/Province

East Azerbaijan

ZIP/Postal Code

51664

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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

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