Leucocytes - and Platelet Rich Fibrin Versus Connective Tissue Graft Associated to Coronally Advanced Flap in the Treatment of Miller Class I and II Localized Gingival Recession: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Recession depth (RD)
研究概览
简要总结
Background: Nowadays, the use of connective tissue graft associated to the coronally advanced flap is considered the "gold standard" for localized gingival recession treatment. However, this technique requires a donor site, which can be associated with greater morbidity. The use of platelet concentrates, particularly the Leukocytes- and Platelets Rich Fibrin (L-PRF), it has emerged as an alternative for gingival recession treatment, due to its properties which enhance the regenerative process. Therefore, the purpose of this study was to evaluate and to compare the effect obtained with L-PRF versus connective tissue graft (CTG) associated to the Coronally Advanced Flap (CAF) in the treatment of Miller class I or II localized gingival recessions.
Methods: A randomized controlled clinical trial of parallel groups (1:1) with 17 recessions in each group was performed. Control group (CAF + CTG) and test group (CAF + L-PRF). In each group the following variable were measured: postoperative pain and incidence of post-surgical complications at 24-48-72 hours, gingival recession depth (RD), gingival recession width (RW), gingival thickness (GT), probing depth (PD), clinical insertion level (NIC), keratinized tissue height (KTH) before treatment and after 1, 3 and 6 months of root covering surgery and the root coverage esthetic score (RES) at 6 months after treatment.
详细描述
Study design and participants A randomized controlled clinical trial of parallel groups (1:1) with 17 recessions in each group was performed. Control group (CAF + CTG) and test group (CAF + L-PRF). This study was approved by the ethical committee of Universidad de Los Andes, Santiago Chile (CEC201627) and in full accordance with the ethical principles of the Declaration of Helsinki, as revisited in 2000. The patients were instructed about the benefits and risks of the study and each participant signed an informed consent form.
Thirteen patients (9 females and 4 males; aged 26 to 53 years; mean year: 41,74; SD: 9,11 years) with a total of 34 gingival recession (27 in females and 7 in males) participated in the present study. (Figure 1)
The sample size was based on the detection of 1 mm difference in gingival recession reduction between the treatment groups (standard deviation 0.93), with a two-sided 5% significance level, a power of 85%.(36) The sample size calculation was obtained using the software STATA v14.0.
Initial therapy and clinical measurements The patient enrolled received a prophylaxis session (scaling and professional tooth cleaning), all patients had less of 20% of plaque or 80% oral hygiene according to the O´Leary oral hygiene index.(37) All clinical parameters measurements were performed by a single trained and calibrated examiner (C.A.) and masked for the treatment assigned. An Individual acrylic stents were prepared for all patients to take measurements of the constant points.
The following parameters were evaluated at baseline and 1, 3, and 6 months after treatment: 1) gingival recession depth (RD), distance between CEJ and gingival margin (GM); 2) gingival recession wide (RW), measured at CEJ level; 3) probing depth (PD), measured from margin of the gingiva to the gingival sulcus base; 4) clinical attachment level (CAL), measured from the CEJ to the gingival sulcus base; 5) keratinized tissue height (KTH), measured from the mucogingival junction to the gingival margin; 6) gingival thickness (GT) at 3 mm from the gingival margin, measured un local anesthesia with an endodontic spacer Nº 25 with its stopper silicone disc and an endodontic rule; 7) root coverage (RC) was calculated in millimeters and percentages according to the following formula: [(pre-operative RD - post-operative RD)/pre-operative RD] × 100.
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 (Investigator, Outcomes Assessor)
盲法说明
The clinician who performed the measurements as well as the statistic were blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients
- •Older than18 years
- •At least one localized Miller class I or II gingival recession higher than 3mm at buccal aspect of anterior/premolar area
- •An identifiable cement-enamel junction (CEJ)
- •Without bleeding on probing (BOP)
- •Pulp vitality
排除标准
- •Pregnancy
- •Active periodontal disease
- •Previous periodontal surgical procedures in the recession area
- •Coagulation disorders
- •Anticoagulant treatment
- •Patients who cannot comply the study and/or maintenance visits.
结局指标
主要结局
Change in Recession depth (RD)
时间窗: At 1 month, 3 months and 6 months
pre-operative RD - post-operative RD in millimeters
次要结局
- Change in Percentage of root coverage(At 1 month, 3 months and 6 months)
- Post- operative pain(At 24, 48 and 72 hours after surgery.)
- Change in Recession wide (RW)(At 1 month, 3 months and 6 months)
- Change in Probing depth (PD)(At 1 month, 3 months and 6 months)
- Post-surgery complications incidence(At 24, 48, 72 hours.)
- Change in Gingival thickness (GT)(At 1 month, 3 months and 6 months)
- Change in Clinical attachment level (CAL)(At 1 month, 3 months and 6 months)
- Change in Keratinized tissue height (KTH)(At 1 month, 3 months and 6 months)
- Root Coverage Esthetic Score (RES)(At 6 months)
研究者
Catherine Andrade
Principal investigator
Universidad de los Andes, Chile