Treatment of Miller Class I Gingival Recessions by CAF with or Without Platelet-Rich Fibrin: a Randomized Clinical Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- PERCENTAGE (%) OF ROOT COVERAGE (PRC)
研究概览
简要总结
The objective of this study was to compare the efficacy of Coronal Advanced Flap (CAF) alone versus CAF combined with Leukocyte-Platelet-Rich Fibrin (L-PRF) to achieve root coverage in patients with gingival recession. This was assessed by measuring the percentage of root coverage at six months post-surgery. By focusing on the root coverage level, the study aimed to determine whether adding L-PRF to CAF significantly improved over using CAF alone.
The other objective was to provide a comprehensive assessment of the outcomes related to root coverage and overall patient satisfaction. Moreover, different outcomes of recession coverage were assessed, including the percentage of complete root coverage and mean root coverage. These evaluations were intended to offer a more detailed understanding of the possible success of each surgical technique. Additionally, the difference in gingival tissue thickness between the two groups was attempted to measure at six months post-surgery to determine whether the addition of L-PRF to CAF improved tissue quality and stability.
The study also aimed to determine the overall volume gain in gingival tissue in the specific area of recession covered by both techniques, providing information on their regenerative capabilities and the three-dimensional changes in tissue structure.
Furthermore, it sought to analyze the healing and recovery processes by comparing postoperative complications, patient discomfort, and overall recovery time between the two groups. Finally, another goal was to investigate the patient's satisfaction with the aesthetic and functional outcomes of the procedures, evaluating their perceptions of the success of treatment and the quality of life after surgery. This comprehensive approach was designed to ensure that all relevant outcomes were considered, offering a robust evaluation of the effectiveness and benefits of combining CAF with L-PRF and providing comparability with previous and future studies.
The positive hypothesis raised was: CAF combined with L-PRF will: (a) result in significantly greater root coverage compared to CAF alone at six months post-surgery; (b) lead to thicker gingival tissue and better tissue quality compared to CAF alone; (c) will have a faster healing and recovery, with fewer complications in the CAF with L-PRF group compared to the CAF alone group; (d) will report higher satisfaction levels with the treatment outcomes compared to those undergoing CAF alone.
详细描述
A clinician not involved with the care of participants assessed eligibility and filled out the data form, and after receiving the allocation information from the randomization unit, the surgeon, a clinician not involved in data collection, started the protocolized procedure.
BLOOD COLLECTION: If a patient was assigned to the test group (L-PRF), a designed nurse proceeded to the blood collection to obtain L-PRF. A vein (basilica, cephalic, or median), usually on the inside of the elbow or the back of the hand, was the source of blood. The area where the puncture occurred was cleaned with an antiseptic. An elastic band or pressure cuff was wrapped around the forearm to squeeze the vein and make it more noticeable under the band. This helped the needle find the vein more easily.
As soon as that was done, a needle was placed in the vein, and blood was collected in a clean and sealed plastic tube (Intra Spin™ - Intra-Lock), between 4 and 6 tubes, without anticoagulant. During the process, the band was removed to allow blood to flow normally, and after the blood was collected, the needle was removed, and the puncture site was covered to prevent bleeding. The L-PRF membranes were prepared according to the technique described by Choukroun et al. (2001). Tubes were centrifuged immediately at 2700 rpm for 12 minutes on the centrifugation machine (Intraspin™, Intra-lock®, Florida, USA).
After centrifugation, the gelatinous portion obtained from each tube was removed and separated from the red part with tweezers. The membranes obtained were placed on a sterile metal surface.
The light metal plate and cover of the compression box (e.g., Xpression™ Intra-Lock, Boca Raton, FL, USA) were used to gently compress the L-PRF clots by gravity. After five minutes, the L-PRF membranes could be used.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People over 18 years of age
- •Nonsmokers or smokers with less than ten cigarettes (self-reported)
- •No medical pathology that prevents the application of treatments affects the response of these and the healing process: protein and vitamin deficiency, therapeutic radiation, metabolic disorders (diabetes, hypercalcemia, and others.), drug disorders (antimetabolic, immunosuppressive) and hormonal, allergy to some component of the treatments applied in the study.
- •Not be pregnant.
- •The presence of oral health with the plaque control record (PCR) and bleeding on probing (BOP)is less than 25%
- •At least, the presence of two or more neighboring, or not, gingival recessions Miller class 1 in the anterior upper jaw (central and lateral incisors, canine, first and second premolars.
排除标准
- •not accepted participation in the study
- •not signed the informed consent
- •recession greater than Miller's class1 or RT-1
- •presence of any non-controlled disease. 4) Gingival recessions present a minimal amount (>1,5 mm) of keratinized tissue (KT) apical to the recession area.
- •Pocket depth (PD) </=3 mm and CAL interproximal </ = 0 6) Absence of carious lesions, occlusal trauma, or previous root cover procedures.
- •Absence of a prosthetic crown on experimental teeth.
结局指标
主要结局
PERCENTAGE (%) OF ROOT COVERAGE (PRC)
时间窗: 6 months
The primary outcome of this trial was the percentage of root coverage achieved at six months post-surgery. This outcome was chosen due to its high clinical relevance and direct impact on patient care. Clinically, the percentage of root coverage is a crucial measure of success in periodontal surgical procedures aimed at treating gingival recession. It indicates how effectively the exposed root surface has been covered by gingival tissue. The objective is to evaluate whether L-PRF, combined with the coronal advancement flap for root coverage in Miller Class 1 recessions in upper front teeth, will show any significant clinical difference in the root coverage percentage compared to the coronal advancement flap alone. We used two methods to measure the percentual of root coverage: one based on the changes in recession depth (standard), and one based on the changes in recession area for comparison. This metric represents the exact p
COMPLETE AND MEAN ROOT COVERAGE
时间窗: 6 months
% of complete root coverage (%CRC) Complete root coverage indicates that the gingival margin has been successfully repositioned to cover the previously exposed root surface, which is often the primary goal of these treatments. Provides a clear binary outcome (complete vs. incomplete), making it easy to interpret. This measurement is directly correlated with patient satisfaction. Patients typically seek treatment for gingival recession to address aesthetic and sensitivity issues. Patients may only be satisfied when they achieve total coverage of the root surface. Mean Root coverage (MRC) This metric represents the average root coverage achieved in a sample or study group, expressed in absolute terms (e.g., millimeters). It is an absolute measurement that provides information about the amount of root coverage achieved, which can be clinically important.
次要结局
- KERATINIZED TISSUE WIDTH GAIN(6 months)
- THICKNESS GAIN(6 months)
- PAIN AND HEALING ASSESSMENT(6 months)
- SUBJECTIVE EVALUATION OF RESULTS BY THE PATIENT(6 months)
研究者
Gustavo Fernandes, DDS, MSc, PhD
PhD
Universidade Salgado de Oliveira