Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Probing depth
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of using L-PRF (leukocyte and platelet rich fibrin clot) as an autologous filling material in conjunction with the EPP (entire papilla preservation) technique for the treatment of interproximal intraosseous periodontal defects, compared to the same technique without L-PRF regarding clinical periodontal parameters and obtained radiographic parameters. It will also report possible postoperative complications and evaluate postoperative sensitivity. The main questions it aims to answer is:
• What is the effectiveness of LPR-F in conjunction with a complete papilla preservation (EPP) technique for the treatment of intrabony periodontal defects in CESA (health care center) patients in terms of clinical and radiographic periodontal parameters compared to the use of the same technique without L-PRF?
A non-randomized controlled clinical trial will be conducted on patients at CESA of the Universidad de los Andes. In 30 patients, 30 periodontal defects associated with a pocket with probing depths equal to or greater than 6 mm will be treated using the complete papilla preservation technique, either with L-PRF filling or without any filling material, assigned randomly to each intervention (15 participants in each group). Researchers will evaluate clinical and radiographic parameters at baseline and 6 months post-surgery. Patients will report their level of pain 24 hours and 7 days after surgery.
详细描述
Periodontitis is an infectious disease of bacterial origin that leads to a slow and progressive loss of periodontal attachment, resulting in the destruction of supporting tissues and the formation of periodontal pockets. These pockets can be classified as suprabony or intrabony, with the latter being those where the bottom of the pocket is apical to the level of the adjacent alveolar bone and the bone loss presents a vertical pattern. Intraosseous defects affect 36% of periodontal patients and are particularly challenging to treat due to their association with greater loss of periodontal support, increased clinical attachment loss, deeper probing depths, greater tooth mobility, and functional consequences for the patient; thus, they have a less favorable prognosis and response to non-surgical periodontal treatment.
Lang et al. established that periodontal defects can be successfully treated with non-surgical therapy, limiting additional surgical interventions to sites with an initial probing depth of 6 mm or more, or to advanced periodontal lesions that, after a successful etiological phase, still retain residual pockets ≥ 6 mm. Given this, surgical periodontal therapy becomes a therapeutic alternative for intraosseous defects associated with advanced periodontal destruction, aiming to reduce tooth loss over time, recover lost periodontal support, and improve patient's quality of life.
Different surgical alternatives have been developed to enhance short- and long-term clinical outcomes in teeth with infrabony defects and reduced periodontal support. If the contour of the existing bone and the number of remaining bony walls are favorable, regenerative surgical therapy could successfully regenerate bone up to the level of the alveolar crest. The use of materials such as a demineralized allogeneic bone matrix in guided tissue regeneration has shown to achieve reductions in probing depths, gains in clinical attachment level, and filling of treated defects compared to defect instrumentation through open flap debridement.
However, these treatment modalities are sensitive to technique, and their outcomes depend on various factors including patient-dependent factors such as plaque control and smoking habits; site-specific factors, such as defect morphology; and factors inherent to the surgical techniques employed. Consequently, the failure of conventional surgical techniques, such as early exposure of the regenerated area, has been reported in the scientific literature and is even more frequent with the use of membranes and bone substitutes.
In light of this, innovations in flap design and soft tissue management have reduced failures associated with early wound closure. Surgical techniques such as simplified papilla flap and modified techniques, minimally invasive surgical technique (MIST), and modified minimally invasive surgical technique (M-MIST) have been designed to protect the regeneration site and facilitate the stability of the blood clot.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with periodontal disease (loss of interproximal clinical attachment loss in 2 non-adjacent teeth or clinical attachment loss of ≥3mm associated with a PD >3 mm in two or more teeth) will be included.
- •After re-evaluation (6 weeks after non-surgical periodontal therapy) presented residual probing depths equal to or greater than 6 mm.
- •Residual pocket is associated with interproximal intrabony periodontal defects of at least 2 walls, with a depth ≥ 3 mm and an angulation ≤ 40º determined on a periapical radiograph.
排除标准
- •Patients with an underlying decompensated pathology such as diabetes and hypertension.
- •Patients taking medications that interfere with the healing process such as bisphosphonates.
- •Patients with diseases that alter bone metabolism such as osteoporosis.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
EPP with L-PRF as a filling material
This group will have the infrabony defect treated with the use of an EPP minimally invasive technique and the defect will be filled with L-PRF.
干预措施: REGEND001 Autologous Therapy Product (Procedure)
EPP with L-PRF as a filling material
This group will have the infrabony defect treated with the use of an EPP minimally invasive technique and the defect will be filled with L-PRF.
干预措施: Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery (Procedure)
EPP with no defect filling material
This group will have the infrabony defect treated with the use of an EPP minimally invasive technique, but the defect will not be filled with L-PRF.
干预措施: Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery (Procedure)
结局指标
主要结局
Probing depth
时间窗: From enrollment to the end of treatment 6 months postoperatively
Distance between the gingival margin and the bottom of the periodontal sulcus or pocket.
Mesiodistal width (M-D) of the defect
时间窗: From enrollment to the end of treatment 6 months postoperatively
Distance between the mesial and distal wall of the osseous defect
Clinical attachment level
时间窗: From enrollment to the end of treatment 6 months postoperatively
Distance between the cemento-enamel junction (CEJ) or a stable reference to the bottom of the periodontal pocket.
Distance from contact point to tip of papilla (PP)
时间窗: From enrollment to the end of treatment 6 months postoperatively
Distance between the interproximal contact point and the tip of the interproximal papilla
Bleeding on probing
时间窗: From enrollment to the end of treatment 6 months postoperatively
It will be evaluated dichotomously in 6 sites per tooth and will be defined as a percentage by dividing the sites that bleed on probing with the total number of sites examined multiplied by 100.
Keratinized Gingiva Width
时间窗: From enrollment to the end of treatment 6 months postoperatively
Distance between the tip of the interproximal papilla and the mucogingival line.
Infrabony component of the defect (INFRA)
时间窗: From enrollment to the end of treatment 6 months postoperatively
Determined by the subtraction between distance from CEJ to the bottom of the defect (BD) minus the distance from CEJ to the tip of the interproximal crest (IC)
Buccal-palatal/lingual width (B-P/L) of the defect
时间窗: From enrollment to the end of treatment 6 months postoperatively
Distance between the bucal and palatal/lingual wall of the osseous defect in mm.
Defect filling percentage after surgery (%DF)
时间窗: From enrollment to the end of treatment 6 months postoperatively
Measured by subtraction between distance from CEJ to the bottom of the defect (BD) minus the distance from CEJ to the tip of the interproximal crest (IC), allowing the calculation of percentage defect filling (%DF) after surgery
次要结局
- Patient reported outcome: Pain(24 hours after surgery and one week after surgery)
