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临床试验/NCT03043638
NCT03043638已完成不适用

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

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization0 个研究点目标入组 12 人开始时间: 2008年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
主要终点
Root coverage (RC)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
34 Years 至 57 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Root coverage (RC)

时间窗: The change in RC at 3rd month to 12th month

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

次要结局

  • width of keratinized tissue (WKT)(Baseline, 3,6 and 12 months after periodontal surgery)
  • probing depth(Baseline, 3,6 and 12 months after periodontal surgery)
  • gingival index(Baseline, 3,6 and 12 months after periodontal surgery)
  • plaque index(PI)(Baseline, 3,6 and 12 months after periodontal surgery)
  • 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)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

PELİN GÖKALP

Principal Investigator

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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