Comparison of Different De-epithelialization Techniques of Soft Tissue Grafts.

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-04

Study Completion Date

2022-08-05

Brief Summary

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In this randomized comparative controlled clinical trial, 50 patients with single recession defects with thin phenotype were treated with coronally advanced flap. The connective tissue graft was obtained by removing the keratinized layer of the tissue. Removal of the epithelium was achieved by to different approach. At first group epithelium and remnants were removed extraorally whereas others were intraorally. After the removal, obtained graft laid on a lamella, and residual keratinocytes were observed under the microscope. Amount of recession reduction recorded at the 6th week, 6th month, 12th month, and keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were also evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.

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Detailed Description

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Conditions

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Connective Tissue Graft Harvesting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Patients were randomly assigned into intraorally de-epithelialization group (n=25) and extraorally de-epithelialization group (n=25) groups by one of the authors with an allocation ratio of 1:1 using a computer-generated program after successful completion of the phase I periodontal treatment. One calibrated author masked the applied surgical technique and recorded all clinical variables. The surgeon opened the labeled envelope containing the intervention name.

Study Groups

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Intraoral

In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.

Group Type ACTIVE_COMPARATOR

Intraorally de-epithelialization

Intervention Type PROCEDURE

In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.

Extraoral

In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Group Type ACTIVE_COMPARATOR

Extraorally de-epithelialization

Intervention Type PROCEDURE

In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Interventions

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Intraorally de-epithelialization

In this group, the grafts were de-epithelialized at the donor site before harvesting. The calibrated surgeon removed the epithelium with a sharp Kirkland knife under magnification. To be sure of the elimination whole epithelial layer, bleeding was observed. Recipient site was prepared as follows; A after sulculer incision had done (blade 15c) two vertical incions were made from the gingival margin to 3 mm beyond the mucogingival junction A partial-thickness flap was elevated under the recession area and full thickness flap elevated adjacent flap portions. then relasing incisions were made apically from the mucogingival junction. After the preparation of the recipient site, obtained graft was sutured 1 mm apically to the cemento-enamel junction. Finally flap was positioned without tension and stabilized at least 2mm coronally from the cemento-enamel margin with the single interrupted sutures.

Intervention Type PROCEDURE

Extraorally de-epithelialization

In this group, the grafts were de-epithelialized after graft harvesting. The calibrated surgeon removed the epithelium with 15 c knife under magnification. all remnants were removed under magnification. Same recipient site procedure was conducted in this group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Single tooth recession more than 2mm
* Gingival thickness less than 1mm

Exclusion Criteria

* unstable endodontic conditions or presence of any restoration/abrasion,
* tooth mobility, any surgical history or gingival enlargement in the area,
* smoking
* uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes