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临床试验/CTRI/2025/03/082828
CTRI/2025/03/082828尚未招募不适用

Effect of injectable platelet rich fibrin vs probiotic[Bifidobacterium[2x10^9CFU/G] augmented injectable platelet rich fibrin in intra osseous defects of stage III periodontitis patients

Digavinti Sushmitha1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年3月28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
28
试验地点
1
主要终点
Reduction in probing pocket depth

研究概览

简要总结

Nonsurgical therapy

·       Case history will be recorded in standard proforma after obtaining written consent

·       Oral Hygiene Instructions will be given and Scaling and Root planing will be performed to control supra and sub gingival plaque.

·       Clinical parameters and radiographic parameters will be evaluated at baseline, and 9 months after regenerative therapy.

Clinical parameters

·       Plaque index (PI)  (Silness and Loe, 1964).

·       Gingival index (GI) (Loe and Silness, 1963).

·       Probing pocket depth (PPD): will be measured at six sites around the teeth using UNC 15 probe.

·       Clinical attachment level (CAL): will be measured from the CEJ to the base of the pocket

·        Relative attachment level (RAL): will be measured from a reference point other than CEJ (stent) to the base of the pocket

Radiographic parameters

·       All patients will undergo CBCT (Cone Beam Computed Tomography) for locating bony defects.

·       CBCT will be taken to obtain 3-dimensional visualization of intra bony defects.

·       Defects will be measured from Cemento enamel junction to alveolar crest.

Surgical therapy:

All routine tests will be carried out before starting the surgery.The surgical procedure will be performed under local anesthesia using 2% lignocaine hydrochloride containing adrenaline at a concentration of 1: 200000.A full thickness mucoperiosteal flap will be raised and the intra bony defect will be debrided and Injectable Platelet Rich Fibrin (I- PRF) will be obtained from the patient. The defect will be filled with I-PRF in Group A and I-PRF augmented with 1 gram probiotic [Bifidobacterium(2X109 CFU/g)] in Group B and  suturing will be done.

Injectable-Platelet Rich Fibrin:

The I-PRF will be prepared following the protocol developed by Miron et al., intravenous blood (by venipuncturing of the antecubital vein) will be collected in 10-ml plastic tubes without anticoagulant and immediately centrifuged in centrifugation machine at 700 revolutions per minute for 3 minutes. The I- PRF will be collected from the top layer and used for regeneration in group A. In group B I- PRF would be mixed with I gram of probiotic containing Bifidobacterium animalis lactis resulting in a steak and will be placed into the defect.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Presence of 16 natural teeth, Maxillary and mandibular molars with intraosseous defects.

排除标准

  • Medically compromised patients, Patients on any medications known to affect the outcomes of periodontal therapy, Insufficient platelet count, Pregnant or lactating women.
  • • Smokers or subjects using any form of tobacco • Furcation involvement more than 3mm • Grade II and grade III mobility.

结局指标

主要结局

Reduction in probing pocket depth

时间窗: Baseline, 6months

Clinical attachment level gain

时间窗: Baseline, 6months

Radiographic bone defect fill

时间窗: Baseline, 6months

次要结局

  • Decreased Bleeding on probing(Reduction in Plaque index score)

研究者

发起方
Digavinti Sushmitha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Digavinti Sushmitha

Vydehi Institute of Dental Sciences and Research Centre

研究点 (1)

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