Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions

NCT03043638 | Completed

• 1 other identifier: 03/2007-28
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to evaluate the effectiveness of platelet rich plasma (PRP) combined with coronally advanced flap plus acellular dermal matrix application (CAF+ADM) in the treatment of multiple adjacent gingival recessions (MAGRs). 12 patients with 84 Miller Class I or II recession defects were participated. Sites were randomly assigned into CAF+ADM+PRP or CAF+ADM groups. Gingival recession depth (GRD), recession width (GRW), width of keratinized tissue (WKT), creeping attachment (CRA), root coverage (RC) as well as plaque index, gingival index, probing depth (PD), and clinical attachment level (CAL) were recorded at baseline and 3rd,6th and 12th months postoperatively. The data were analyzed statistically.

Conditions

Gingival Recession, Generalized

Keywords

multiple adjacent gingival recessions; platelet rich plasma; acellular dermal matrix; coronally advanced flap; gingival recession; root coverage; clinical attachment level

Outcome Measures

Primary Outcomes (1)

• Root coverage (RC)

  The percentage of root coverage (RC) was calculated as (\[GRD preoperation - GRD postoperation\] / GRD preoperation) x 100%.

  The change in RC at 3rd month to 12th month

Secondary Outcomes (6)

• Gingival recession depth (GRD)

  Baseline, 3,6 and 12 months after periodontal surgery

• recession width (GRW)

  Baseline, 3,6 and 12 months after periodontal surgery

• width of keratinized tissue (WKT)

  Baseline, 3,6 and 12 months after periodontal surgery

• plaque index(PI)

  Baseline, 3,6 and 12 months after periodontal surgery

• gingival index

  Baseline, 3,6 and 12 months after periodontal surgery

Study Arms (2)

CAF+ADM+PRP

EXPERIMENTAL

Surgery will include Coronally advanced flap(CAF) plus acellular dermal matrix (ADM) combined with platelet rich plasma (PRP)

Procedure: CAF+ADM+PRP

CAF+ADM

ACTIVE COMPARATOR

Surgery will include only Coronally advanced flap CAF technique including ADM placement without PRP

Procedure: CAF+ADM

Interventions

CAF+ADM+PRP PROCEDURE

CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.

CAF+ADM+PRP

CAF+ADM PROCEDURE

CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application

CAF+ADM

Eligibility Criteria

• Age: 34 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of the presence of at least three multiple adjacent Miller class I or II recessions on both sides of the same maxillary or mandibular arch
• must be able to have 2 mm-high keratinized tissue apical to the root exposures;
• must be able to have no systemic diseases that could influence the outcome of the therapy;
• must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
• must be non-smoker;
• must be not pregnant.

You may not qualify if:

• debilitating systemic or infectious diseases (human immunodeficiency virus or hepatitis) -- -any disease that significantly affects the periodontium;
• known allergy to any of the materials used in the study; requirement for antibiotic prophylaxis;
• taking medications known to interfere with periodontal health and healing not detectable cemento-enamel junction (CEJ);
• restorations or caries at the recession site;
• failure to maintain an oral hygiene level ≥80% plaque-free surfaces; pregnancy or lactation; use of tobacco products; alcohol abuse;
• a previous periodontal surgery at the recession site and failure to complete the informed consent.

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead
• Gazi University: collaborator

Related Publications (2)

• Shepherd N, Greenwell H, Hill M, Vidal R, Scheetz JP. Root coverage using acellular dermal matrix and comparing a coronally positioned tunnel with and without platelet-rich plasma: a pilot study in humans. J Periodontol. 2009 Mar;80(3):397-404. doi: 10.1902/jop.2009.080438.

  PMID: 19254123 BACKGROUND

• Cetiner D, Gokalp Kalabay P, Ozdemir B, Cankaya ZT. Efficiency of platelet-rich plasma on acellular dermal matrix application with coronally advanced flap in the treatment of multiple adjacent gingival recessions: A randomized controlled clinical trial. J Dent Sci. 2018 Sep;13(3):198-206. doi: 10.1016/j.jds.2017.11.002. Epub 2018 Feb 3.

  PMID: 30895121 DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Pelin Gokalp

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: July 1, 2008
• Primary Completion: June 20, 2011
• Study Completion: June 20, 2011
• Last Updated: February 8, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share