Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

NCT ID: NCT02397122

Last Updated: 2018-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-05-31

Brief Summary

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The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.

Detailed Description

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Given the encouraging effects of platelet-rich fibrin (PRF) in healing and regeneration, it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap (CAF)+connective tissue graft(CTG). Therefore, it was aimed to evaluate the effectiveness of CAF + CTG + PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF + CTG in a preliminary, controlled, randomized clinical trial (RCT) with a 6-month follow-up. The study was conducted with 40 patients randomly grouped in half shares into indicated study groups. After phase I therapy, clinical variables including plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded. The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions. Different from CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF patients. Then the gel was placed over the exposed root surface in the same group. The CAF was primarily closed and postoperative instructions were given. After suture removal at second postoperative week, the patients were followed-up by monthly recall visits. Same periodontal clinical variables were recorded 3 and 6 months after surgery.

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

SINGLE

Outcome Assessors

Study Groups

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PRF+CAF+CTG

platelet-rich fibrin + coronally advanced flap + connective tissue graft

Group Type EXPERIMENTAL

platelet-rich fibrin

Intervention Type BIOLOGICAL

autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods

connective tissue graft

Intervention Type PROCEDURE

connective tissue graft was harvested from the palatal region of each patient by single incision method

coronally advanced flap

Intervention Type PROCEDURE

buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)

CAF+CTG

coronally advanced flap + connective tissue graft

Group Type ACTIVE_COMPARATOR

connective tissue graft

Intervention Type PROCEDURE

connective tissue graft was harvested from the palatal region of each patient by single incision method

coronally advanced flap

Intervention Type PROCEDURE

buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)

Interventions

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platelet-rich fibrin

autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods

Intervention Type BIOLOGICAL

connective tissue graft

connective tissue graft was harvested from the palatal region of each patient by single incision method

Intervention Type PROCEDURE

coronally advanced flap

buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Systemically healthy
* Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
* No alveolar bone loss
* Identifiable cemento-enamel junction
* Probing depth ≤3mm

Exclusion Criteria

* Smoking
* Pregnancy
* History of periodontal surgery in last two years
* Mobility
* Excessive occlusal contacts
* Caries
* Loss of vitality
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kırıkkale University

OTHER

Sponsor Role lead

Responsible Party

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H. Gencay Keceli

DDS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KirikkaleU

Identifier Type: -

Identifier Source: org_study_id

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