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临床试验/CTRI/2025/11/097369
CTRI/2025/11/097369尚未招募不适用

Titanium-Prepared Platelet Rich Fibrin on Non-Surgical Periodontal Therapy: A Split-Mouth Randomized Controlled Clinical Trial

Dr Subash Mehta1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Reduction in probing pocket depth (PPD)

研究概览

简要总结

This split-mouth randomized controlled clinical trial aims to assess the adjunctive role of titanium-prepared platelet-rich fibrin (t-PRF) on non-surgical periodontal therapy (scaling and root planing, SRP) in patients with chronic periodontitis. Systemically healthy patient of age between 18-55 years diagnosed with Periodontitis Stage III Grade A will be included.  Patients with contralateral periodontal sites exhibiting similar probing pocket depths (5-6 mm) will receive scaling and root planing (SRP) in all affected areas. Following SRP, test sites will be treated with t-PRF membranes prepared from the patient’s own blood using titanium tubes, while in control sites no additional treatment will be given. Clinical outcomes, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and bleeding on probing (BOP), will be recorded at baseline and at 6 weeks post-treatment. The allocation of test and control sites will be randomized, and the clinical examiner will be blinded. Statistical analyses will compare the clinical improvements between the two groups, with the expectation that t-PRF will enhance healing and improve periodontal parameters more effectively than scaling and root planing alone.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Following patient will be included 1.Systemically healthy or with well-controlled systemic conditions (Diabetes Mellitus, Hypertension, Chronic kidney disease, cardiovascular disease) 2.With periodontitis Stage III Grade A (diagnosed according to the Classification of Periodontal and Peri-Implant Diseases and Conditions 2017) 3.With a 5 – 6 mm probing depth.
  • 4.Patient willing to participate in the study.

排除标准

  • Following patients will be excluded 1.History of systemic disease (Diabetes mellitus,Hypertension, Chronic kidney disease, cardiovascular disease)
  • Presence of active gingival disease 3.Pregnancy and lactation 4.History of any drug or systemic antibiotic usage affecting the periodontium for the past 3 months
  • History of periodontal surgery within the preceding six months 6.Current smokers 7.Teeth with untreated caries
  • Endodontic periapical lesions
  • Grade II or III mobility.

结局指标

主要结局

Reduction in probing pocket depth (PPD)

时间窗: 6 weeks

次要结局

  • 1.Clinical attachment level (CAL)gain.(2.Reduction in Plaque Index score)

研究者

发起方
Dr Subash Mehta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Subash mehta

Aiims, Rishikesh

研究点 (1)

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