Adjunctive Use of Injectable PRF in Non-surgical Periodontal Therapy: Clinical and Microbiological Outcomes ( Split - Mouth Randomized Controlled Trial )
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. The study uses a split-mouth design where one side of the mouth receives the treatment with i-PRF and the other side receives standard treatment alone. Clinical parameters and bacterial counts will be compared at baseline, 1 month, and 3 months after intervention .
详细描述
Patients with periodontitis will be recruited for this split-mouth randomized controlled trial. All participants will receive full-mouth supra and sub-gingival scaling and root planing (SRP). In the intervention side, i-PRF will be injected into the periodontal pockets, while the control side will receive SRP only.
Clinical measurements including Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), and Bleeding on Probing (BOP) will be recorded. Additionally, microbiological samples will be collected to assess the changes in the subgingival Porphyromonas gingivalis and Fusobacterium nucleatum . Follow-up visits are scheduled at 1 and 3 months post-intervention to assess the adjunctive benefit of i-PRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study follows a double-blind protocol regarding outcome assessment and data analysis. The clinical and microbiological examiner (Outcomes Assessor) is masked to the treatment allocation. Furthermore, the statistician (Statistical Investigator) will receive the data in a coded format (e.g., Side A and Side B) without knowing which side received the i-PRF intervention until the final analysis is completed
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects aged 30 years and above.
- •No history of systemic diseases (e.g., diabetes mellitus).
- •Not currently under active periodontal therapy or joining other trial in the last 3 months.
- •Diagnosis with Stage II or III Periodontitis.
- •presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD >4mm at ≥2 teeth.
排除标准
- •Smokers or alcohol users.
- •Patients consuming antibiotics or anticoagulants.
- •Regular users of non-steroidal anti-inflammatory drugs.
- •Receipt of periodontal treatment within 3 months prior to the study.
- •Any bleeding or clotting disorders.
- •Teeth with Grade II or Grade III furcation involvement.
- •Pregnant or breastfeeding mothers.
- •Patients unwilling to participate.
研究组 & 干预措施
Experimental: i-PRF + SRP
This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets
干预措施: Injectable Platelet-Rich Fibrin (i-PRF). (Biological)
Experimental: i-PRF + SRP
This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets
干预措施: Scaling and Root Planing (SRP). (Procedure)
Active Comparator: SRP Alone
This contralateral quadrant of the mouth will receive full-mouth scaling and root planing (SRP) only, serving as the control side to compare with the i-PRF intervention.
干预措施: Scaling and Root Planing (SRP). (Procedure)
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: Baseline, 1 month, and 3 months post-intervention
Probing pocket depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a standardized periodontal probe (e.g., William's probe) at six sites per tooth.
次要结局
- Clinical Attachment Level (CAL)(Baseline, 1 month, and 3 months post-intervention)
- Bleeding on Probing (BOP)(Baseline, 1 month, and 3 months post intervention)
- Plaque Index (PI)(Baseline, 1 month, and 3 months post intervention .)
- Microbiological Analysis (Bacterial Load)(Baseline, 1 month, and 3 months post intervention)
研究者
Thuraya ayad taher al-jubori
Master student
Al-Mustansiriyah University