Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-29

Study Completion Date

2024-03-27

Brief Summary

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The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.

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Detailed Description

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Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Connective Tissue Graft

A connective tissue graft from the patient's palate will be used

Group Type ACTIVE_COMPARATOR

Tunneled coronally advanced flap

Intervention Type PROCEDURE

Describes the flap design for both treatment arms

Allogenic Dermal Matrix with Platelet-Rich Fibrin

An allogenic dermal matrix with the patient's platelet-rich fibrin will be used

Group Type EXPERIMENTAL

Tunneled coronally advanced flap

Intervention Type PROCEDURE

Describes the flap design for both treatment arms

Interventions

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Tunneled coronally advanced flap

Describes the flap design for both treatment arms

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Periodontally and systemically healthy adults
* Full-mouth plaque score and full-mouth bleeding score ≤ 20%
* Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage
* No interproximal attachment/bone loss
* No prior experience of root coverage procedures within the last 1 year
* The patient must be able to perform good oral hygiene

Exclusion Criteria

* Contraindications for undergoing periodontal surgery
* Teeth with more than Grade II mobility, or furcation involvement of Class III
* Patients pregnant or attempting to get pregnant (self-reported), or nursing women
* Untreated/active periodontitis, or other untreated acute infections at the surgical site
* Untreated malignancies at the surgical site
* Persistence of uncorrected gingival trauma from traumatic toothbrushing
* Presence of severe tooth malposition, rotation or clinically significant super-eruption
* Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping
* Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia
* Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation
* Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes