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临床试验/CTRI/2023/08/056065
CTRI/2023/08/056065已完成不适用

Comparative evaluation of bone dimensional changes in extraction socket after spontaneous healing and extraction socket preserved with demineralized freeze dried bone allograft and autologous fibrin glue (sticky bone): A randomized controlled clinical trial

Mansi Sharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月13日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Changes in buccolingual/ palatal width of alveolar ridge

研究概览

简要总结

TITLE OF THE STUDY: Comparative evaluation of bone dimensional changes in extraction socket after spontaneous healing and extraction socket preserved with demineralized freeze dried bone allograft and autologous fibrin glue (sticky bone): A randomized controlled clinical trial

AIM AND OBJECTIVE: To compare the clinical and radiographic effects of demineralized freeze dried bone allograft and autologous fibrin gel (sticky bone) in alveolar socket preservation after tooth extraction compared with extraction alone.

TYPE OF STUDY: A randomized controlled clinical trial

30 such cases will be included in the study meeting the inclusion criteria. Sample will be divided into two groups 1) Control group Atraumatic extraction with collagen plug 2) Test group Atraumatic extraction with sticky bone and collagen plug. Followed  by extraction cross mattress suture will be taken in both groups. Clinical assessment done after 1 week followed by suture removal. Clinical and radiographic parameters will be evaluated at baseline and 6 months interval. Collected data will be analyzed using t-test.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Extraction of at least two teeth which are not adjacent to each other (root pieces, severe decay, inability to restore, root fracture, periodontal disease, failed endodontic treatment) Only anterior teeth and premolar teeth are to be included Radiographic bone height of ≥ 4 mm at site intended for surgery.

排除标准

  • Patients with acute periapical or periodontal infections.
  • Inability to maintain adequate oral hygiene.
  • (Full mouth plaque level of more than 30%).
  • Any medical condition that contraindicated surgery.
  • (Uncontrolled systemic diseases).
  • Pregnancy or lactation Absence of one or two adjacent teeth.

结局指标

主要结局

Changes in buccolingual/ palatal width of alveolar ridge

时间窗: Baseline | 6 months

Changes in vertical height of alveolar ridge

时间窗: Baseline | 6 months

Bone density

时间窗: Baseline | 6 months

次要结局

  • Changes in probing depth (PD) at teeth adjacent to the(extraction site)

研究者

发起方
Mansi Sharma
申办方类型
Government medical college

研究点 (1)

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