跳至主要内容
临床试验/CTRI/2021/03/031929
CTRI/2021/03/031929尚未招募不适用

“Comparative Clinical and Radiographic Evaluation of the Efficacy of Autologous Injectable Platelet-Rich Fibrin (iPRF) with Demineralized freeze dried bone allograft (DFDBA) and Normal Saline with Demineralized freeze dried bone allograft (DFDBA) used in the Treatment Of Intrabony Defects in Chronic Periodontitis Patients –A Randomized Clinical Trialâ€

DR BHALCHANDRA THORAT1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月19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
40
试验地点
1
主要终点
Plaque index(SILNESS & LOE 1964)

研究概览

简要总结

Regeneration of lost structures has become the primary therapeutic goal in periodontics. The objectives of periodontal regenerative therapy are to reconstitute the bone, cementum and periodontal ligament on a previously diseased root surface. Numerous therapeutic modalities for restoring periodontal osseous defects have been investigated. Many of these procedures include the use of bone grafts and bone replacement materials. For the last few decades, demineralized freeze-dried bone allograft (DFDBA) has been used alone and in combination with other treatment modalities for periodontal regeneration. The presence of bone morphogenetic proteins contained within DFDBA aids in

mesenchymal cell migration, attachment, and osteogenesis.

To evaluate and compare clinically and radiographically the effect of Autologus injectable platelet–rich fibrin (iPRF) with demineralized freeze-dried bone allograft(DFDBA) v/s Normal saline with demineralized freeze-dried bone allograft(DFDBA)in the treatment of infrabony periodontal defect and its effecton clinical parameter like Plaque index,  Gingival index, Probing pocket depth and Clinical attachment level.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age group between 20-60years Diagnosis with chronic periodontitis Patients in good systemic health with no contraindication to periodontal surgery Patients having Intrabony defects with pocket depths of 5mm or more,intrabony defect of 3mm with radiographic evidence of vertical / angular bone loss in the affected sites.
  • Involved teeth to be vital and with no endodontic lesion.

排除标准

  • One — wall osseous defects.
  • Patients suffering from any systemic diseases or with compromised immune system.
  • Patients who had received any type of periodontal therapy for the past 6 months Patients taking any immuno-suppressive drugs like corticosteroids.
  • Patients with a known history of allergy to doxycycline or Chlorhexidine or any other medicine are used in the study.
  • Patients showing unacceptable oral hygiene compliance during /after the phase I therapy.
  • Patients taking any drug known to cause gingival enlargement.
  • Pregnant and/or lactating mothers.
  • Patients who were smokers or had tobacco in any other form.
  • Endodontically treated teeth.
  • Patient on anticoagulant therapy Patient with bleeding disorders.

结局指标

主要结局

Plaque index(SILNESS & LOE 1964)

时间窗: baseline 1 month 3months and 6 months postoperatively.

Gingival index(LOE & SILNESS 1963)

时间窗: baseline 1 month 3months and 6 months postoperatively.

Probing pocket depth(PPD)

时间窗: baseline 1 month 3months and 6 months postoperatively.

Clinical attachment Level(CAL)

时间窗: baseline 1 month 3months and 6 months postoperatively.

次要结局

  • Radiographic bone fill will be evaluated using intraoral periapical radiographs of the surgical site.(Radiographs will be taken immediatly post surgery and at six month post surgery)

研究者

发起方
DR BHALCHANDRA THORAT
申办方类型
Other [self sponsored]

研究点 (1)

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