跳至主要内容
临床试验/CTRI/2025/03/083007
CTRI/2025/03/083007尚未招募4 期

THE REGENERATIVE POTENTIAL OF NOVA BONE DENTAL PUTTY AND PLATELET RICH FIBRIN(PRF) IN TREATING HORIZONTAL BONY DEFECTS - A COMPARATIVE SPLIT MOUTH STUDY

FATHIMA SUHARAL1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
REDUCTION IN POCKET DEPTH

研究概览

简要总结

The current randomized split-mouth study consists of 15 systematically healthy patients. Patients will be chosen according to specified inclusion and exclusion criteria. Informed consent will be acquired from each patient, and subsequently, they will be randomly assigned to one of three groups. Group I patients are treated with open flap debridement with intra marrow penetration, Group II patients are treated with open flap debridement with intra marrow penetration and nova bone putty and Group III patients are treated with open flap debridement with intra marrow penetration and platelet rich fibrin.  Initially scaling and root planning will be done under local anesthesia followed by oral hygiene instructions. The patient will be recalled for periodontal surgery.

1     The following clinical and radiographic parameters will be recorded at baseline and 6 months.

2    Plaque Index by Sillness and Loe

3      Gingival Index - Harald Loe & John Sillness

4       Periodontal Probing Depth

5      Clinical attachment level

6      To evaluate bone fill using CBCT

The operated site of patient will be anaesthesia. No 15 blade was used to give crevicular incision and full thickness mucoperiosteal flap will be reflected and the debridement will be done to remove granulation tissue.  Micromotor handpiece and a round carbide bur will used to make intra marrow penetration in the interdental area. The required amount of Nova Bone putty and platelet rich fibrin will be taken and placed in the defect area in Group 2 and Group 3 respectively. The patient will be recalled at 6months after surgery to evaluate clinical and radiographic parameters.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • 1 Systemically healthy patients. 2 Age:
  • 55 years. 3 Minimum of two teeth with Probing pocket depth 5mm OR more 4 Horizontal bone loss more than or equal to 6mm measuring from cemento-enamel junction (CEJ).

排除标准

  • 1 Medically compromised patients.
  • 2 Teeth with grade III mobility.
  • 3 Pregnant and lactating women.
  • 5 Patients on medications known to interfere with periodontal tissue health and healing.
  • • Previous periodontal surgery on the involved teeth.

结局指标

主要结局

REDUCTION IN POCKET DEPTH

时间窗: BASELINE , 6 MONTHS

CLINICAL ATTACHMENT GAIN

时间窗: BASELINE , 6 MONTHS

次要结局

  • Plaque Index(Gingival Index)

研究者

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

FATHIMA SUHARAL

SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE

研究点 (1)

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