Assessment of Liquid Platelet-Rich Fibrin Mixed With Denaturated Albumin Gel (ALB-PRF) or With Bone Allograft in The Treatment of Periodontal Intrabony Defects( Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- pocket depth
研究概览
简要总结
The objective of study also is to assess radiographic linear defect depth, and radiographic defect bone density following the application of liquid Platelet-Rich Fibrin (PRF) mixed with denaturated Albumin gel (ALB-PRF) or with bone allograft in periodontal intrabony defects.
Patients and methods: 28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern. According to the techniques that used in the treatment of periodontal bony defect, the participants will be randomly divided into 4 equal groups: Group I: will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF). Group II: will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects. Group III: will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane. Group IV: will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
详细描述
28 patients will be selected from the outpatient clinic in the Oral Medicine and Periodontology Department, Faculty of Dentistry, Mansoura University according to Pre-operative CBCT that will be used to evaluate the bone destruction pattern.
Sample size will be calculated using G-Power 3.1 for Mac with (α = 0.05, and power = 0.95). One-way ANOVA test will be used and effect size of (0.7) based on the anticipated mean difference of the efficacy of new generation platelet-rich fibrin according Nagy et.al 2021. The total sample size of the four groups will be 28 patients.
Inclusion criteria:
- periodontits stage III according to classification of periodontal and peri-implant disease and conditions (2018).
- Patient with two or three walls or combined bony defect.
- Favorable pattern of occlusion.
- Patient ability to comply with the required recall visits.
Exclusion Criteria:
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
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periodontist stage III according to classification of periodontal and peri-implant disease and conditions (2018).
- •Patient with two or three walls or combined bony defect.
- •Favourable pattern of occlusion.
- •Patient ability to comply with the required recall visits.
排除标准
- •Local or systemic diseases that contraindicate surgery.
- •Patients with parafunctional habits.
- •Pregnancy or lactation.
- •Diabetic patient.
- •Osteoporosis.
- •Immune-suppressed condition that may affect the outcome of the therapy.
研究组 & 干预措施
open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF)
will include 7 patients, in which the intrabony periodontal defects will be treated with open flap debridement and demineralized freeze-dried bone allograft (DFDBA) and mixed with liquid (PRF).
干预措施: Experimental: open flap debridement and demineralized freeze-dried bone allograft and mixed with liquid (PRF (Procedure)
liquid (PRF) mixed with denatured albumin gel (ALB-PRF) injected in periodontal intrabony defects
will include 7 patients, in which participants will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects.
干预措施: defects will be treated with open flap debridement and liquid (PRF) mixed with denatured albumin gel (ALB-PRF) will be injected in periodontal intrabony defects (Procedure)
open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.
will include 7 patients, in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and collagen membrane.
干预措施: defects will be treated with open flap debridement , DFDBA mixed with liquid (PRF) and collagen membrane (Procedure)
open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
will include 7 patients in which participants will be treated with open flap debridement, DFDBA mixed with liquid (PRF) and ALB-PRF membrane.
干预措施: open flap debridement , DFDBA mixed with liquid (PRF) and ALB-PRF membrane. (Procedure)
结局指标
主要结局
pocket depth
时间窗: pocket depth will be assessed at baseline, 3 and 6 months.
pocket depth: by placing dental probe between your teeth and gumline. Pockets are measured at several places in your upper and lower gums. In a healthy mouth, the pocket depth is usually between 1 and 3 millimetres (mm). Pockets deeper than 4 mm may indicate periodontitis
Plaque index
时间窗: At baseline ,3and 6 months
Evaluation of existence plaque in all around tooth aspects
Bleeding on Probing
时间窗: At baseline ,3 and 6months.
Evaluation of existence Bleeding during gentle periodontal probing.
Clinical Attachment Level
时间窗: At baseline ,3 and 6 months.
To assess the clinical attachment level.
次要结局
- Pain score(At day 0,3,5 and 7 post-operatively. While healing will be assess at days 2,7 and 14)
- Bone density(At base line and 6 months starting from base line.)
- Alveolar ridge width (buccolingual).(At base line and 6 months starting from base line.)
- Alveolar ridge height (apicocronal)(At base line and 6 months starting from base line.)