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Completed

NCT Number: NCT00720707

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

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 .

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry- Tabriz University of Medical Sciences

Tabriz, East Azerbaijan Province, 51664, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAF+ADM+EMD

Procedure

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

Other names: Alloderm®, Emdogain®

CAF+ADM

Procedure

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 outcomes

  1. the percentage of root coverage

    Time frame: 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

    Time frame: 6 months after treatment

Sponsors and collaborators

Lead sponsor

Tabriz University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 23, 2008
Registry last updated
Jul 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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