Cor Adv Flap Plus Ac Derm Matrix in Thin Phenotype Multiple Recessions

NCT ID: NCT03883438

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2015-02-15

Brief Summary

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Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft

Detailed Description

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The aim of this study was to evaluate the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap (CAF) and acellular dermal matrix graft (ADMG) in 22 eligible participants.

Conditions

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Gingival Recession, Generalized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 22 patients with 55 recessions were included in this single blind randomized controlled trial. Each patient had at least two recessions with a depth of ≥ 3 mm (Miller Class I\&II) in the upper jaw. The entry criteria were esthetic indication for root coverage; absence of caries or restorations at the selected sites; no history of previous mucogingival therapy; being a non-smoker and a systemically healthy patient.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
A computer program was used to randomize 22 volunteers to treatment groups by a person who was not involved in the study. The result of this randomization process was written on a paper and then put in the sealed opaque envelope by a blinded examiner, in which the treatment procedure for the specific patient was defined. The envelope was opened by surgeon, immediately before starting the surgical procedure.

Study Groups

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Coronally advanced flap and acellular dermal graft

In CAF group, after local anesthesia oblique beveled vertical incisions were made at the most mesial and distal line angles of the recessions. These two incisions were connected with an intra-sulcular and interdental sub-marginal incisions in order to create the external surgical papillae. Then the flap was elevated as a split-full-split approach. The apical portion of the flap was reflected as close to the periosteum as possible by mesio-distal and apical sharp dissection parallel to the mucosa to release residual muscle tension and extended beyond the muco-gingival junction to facilitate the passive coronal replacement of the flap over the defects. In both groups ADMG was used as a sub-epithelial graft considering the manufacturer's instructions. The graft was positioned at the level of cemento-enamel junction and extended to the surrounding bone in the apical direction with full closure of the exposed root surfaces.

Group Type ACTIVE_COMPARATOR

Modified coronally advanced flap and acellular dermal matrix graft

Intervention Type PROCEDURE

Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft

Modified coronally advanced flap and acellular dermal graft

Test group received CAF avoiding vertical releasing incisions (mCAF).

Group Type EXPERIMENTAL

Modified coronally advanced flap and acellular dermal matrix graft

Intervention Type PROCEDURE

Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft

Interventions

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Modified coronally advanced flap and acellular dermal matrix graft

Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I\&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Systemically healthy patients
* Miller Class I \& II multiple buccal recession defects ≥ 3 mm on maxillary incisors, canines or premolars
* Esthetic indication for root coverage
* Probing depth \< 3mm at the recession sites

Exclusion Criteria

* Smokers
* Pregnancy
* Bruxism and occlusal trauma
* Previous root coverage procedure
* Endodontically treated teeth at the recession sites
* Caries or restorations at the recession sites
* Use of antibiotics over the previous 3 months prior to treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Altinbas University

OTHER

Sponsor Role collaborator

Universidade Ibirapuera

OTHER

Sponsor Role collaborator

Universidad El Bosque, Bogotá

OTHER

Sponsor Role collaborator

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

OTHER

Sponsor Role lead

Responsible Party

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Cavid Ahmedbeyli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cavid Ahmedbeyli, PhD

Role: PRINCIPAL_INVESTIGATOR

Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

Locations

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Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors

Baku, , Azerbaijan

Site Status

Ibirapuera University

São Paulo, , Brazil

Site Status

El Bosque University

Bogotá, , Colombia

Site Status

Altinbas University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Azerbaijan Brazil Colombia Turkey (Türkiye)

Other Identifiers

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AZETR201520171001

Identifier Type: -

Identifier Source: org_study_id

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