The Effect of Adjunctive I-PRF on the Outcomes of Minimally-invasive Non-surgical Therapy of Periodontal Intrabony Defects.A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in pocket depth
研究概览
简要总结
The purpose of this study is to evaluate change in pocket depth following using minimally invasive non surgical combined with injectable platelet concentrate .
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 (Outcomes Assessor)
盲法说明
Biostatistician
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with periodontitis stage III-IV.
- •Presence of at least one intrabony defect with radiographic component ≥ 3mm deep and PPD≥ 6mm (not affecting a tooth with 'hopeless' prognosis).
- •Patients willing to sign informed consent and to be in the study until the 6-months follow-up.
- •Full-mouth plaque score <30% following step 1 periodontal therapy
排除标准
- •Smoker/vaper (currently or in past 5 years).
- •Contributory medical history (e.g. cardiovascular disease, diabetes, psychiatric conditions).
研究组 & 干预措施
Intervention , MINST + IPRF
Participants will receive minimally invasive non-surgical periodontal therapy (MINST) with adjunctive local application of injectable platelet-rich fibrin (I-PRF) into the selected periodontal intrabony defect. I-PRF will be prepared from 10 mL of autologous venous blood and injected into the cleaned defect, followed by placement of a custom-made transparent vacuum-formed stent for 15 minutes to prolong local contact. Participants will receive standard oral hygiene instructions and periodontal follow-up.
干预措施: Injectable PRF (Biological)
Control , MINST only
Participants will receive minimally invasive non-surgical periodontal therapy (MINST) alone for the selected periodontal intrabony defect, without adjunctive I-PRF or other biomaterials. Participants will receive standard oral hygiene instructions and periodontal follow-up.
干预措施: MINST (Procedure)
结局指标
主要结局
Change in pocket depth
时间窗: 6 months
Baseline measurements will be taken at the first visit. Probing depth will be measured at six sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) using a UNC-15 periodontal probe
次要结局
- Pocket closure(6 months from baseline)
- Clinical attachment gain(6 months from baseline)
- Radiographic defect reduction:(6 months)
- Patient reported outcomes(6 months)
研究者
Hania wael
Master degree candidate
Cairo University