Clinical trial NCT03043638: Efficiency of PRP on Acellular Dermal Matrix Application in the Treatment of Multiple Adjacent Gingival Recessions
Official title: Efficiency of Platelet-Rich Plasma (PRP) on Acellular Dermal Matrix Application With Coronally Advanced Flap in the Treatment of Multiple Adjacent Gingival Recessions:a Double-masked Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2017-02-06
Enrollment: 12
Sex: ALL
Minimum age (years): 34
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Several methods have been demonstrated for the treatment of gingival recession defects with the use of PRP. In an 8-month randomized controlled trial, it was reported that there was no significant difference between PRP and CTG treated groups in terms of root coverage of Miller Class 1 or II buccal recession defects. However, in the same study contour and texture of soft tissue showed valuable enhancement in PRP group. The use of PRP together with ADM in the treatment of MAGRs may alleviate the need for autogenous donor tissue. Shepherd et al. compared coronally positioned tunnel technique and ADM application with and without PRP for the treatment of single gingival recession defects and reported no statistically significant root coverage difference between groups.

Although there are numerous root coverage procedures to treat the conditions, predictable coverage of multiple adjacent gingival recessions still remains a challenge for the clinician. The aim of this randomized, controlled, clinical trial was to compare the CAF plus ADM application together with and without PRP to determine whether the PRP provided an advantage in terms of gaining coverage of deep and wide recession defects in the treatment of MAGRs.

In the present study, using a controlled blinded split-mouth design, 14 patients with multiple Miller Class I or II adjacent recession defects ≥ 3mm deep on bilateral operation sites were randomly operated either with CAF+ADM+PRP or only CAF+ADM as test and control groups respectively. Two patients who failed to return for all postoperative visits were exited from the study.

Finally12 patients who had adjacent Miller Class 1 or II (Miller) recession defects ≥ 3mm deep on non-molar teeth in the same dental arch at least two bilateral site, underwent through root coverage surgery and were followed for 12 months. The study sample consisted of 84 teeth associated with total of 12 patients; seven patients each showing a pair of three teeth, four patients each showing a pair of four teeth, and one patient showing a pair of five teeth with adjacent multiple recessions deep on the buccal aspect of each tooth. The treated teeth were 26 incisors, 24 canines and 34 first premolars. Standardized radiographs were taken to evaluate the interproximal alveolar bone level. At baseline, 3, 6 and 12 months after the surgeries; Miller classification of the recession defect (Miller, 1985), plaque index (PI) (Silness and Loe, 1964), gingival index (GI) (Loe, 1967) probing depth (PD), clinical attachment level(CAL), Probing depth(PD), gingival margin (GM), Gingival recession width (GRW) were recorded. The pre-surgical evaluation included an analysis of the patient's tooth brushing technique and habits. At the teeth showing gingival recessions, a coronally directed roll technique using a soft toothbrush was indicated to minimize the tooth brushing trauma to the gingival margin. Pre-surgical therapy included scaling, root planning, polishing and general oral hygiene instruction. All surgical procedures were performed with Coronally Advanced Flap technique.

Eligibility criteria: Inclusion Criteria:

1. 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
2. must be able to have 2 mm-high keratinized tissue apical to the root exposures;
3. must be able to have no systemic diseases that could influence the outcome of the therapy;
4. must be able to have a full-mouth plaque score of 20% (O'Leary et al. 1972);
5. must be non-smoker;
6. must be not pregnant.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Root coverage (RC)
timeFrame: The change in RC at 3rd month to 12th month
Secondary outcomes:
measure: Gingival recession depth (GRD)
timeFrame: Baseline, 3,6 and 12 months after periodontal surgery
measure: recession width (GRW)
timeFrame: Baseline, 3,6 and 12 months after periodontal surgery
measure: width of keratinized tissue (WKT)
timeFrame: Baseline, 3,6 and 12 months after periodontal surgery
measure: plaque index(PI)
timeFrame: Baseline, 3,6 and 12 months after periodontal surgery
measure: gingival index
timeFrame: Baseline, 3,6 and 12 months after periodontal surgery
measure: probing depth
timeFrame: Baseline, 3,6 and 12 months after periodontal surgery
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Pelin Gokalp
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.