跳至主要内容
临床试验/CTRI/2022/07/044005
CTRI/2022/07/044005尚未招募不适用

Assessment of extraction socket preservation using Naturally sourced (Eggshell derived) Nano-hydroxyapatite graft covered with and without figure of eight suture for stabilization - A prospective study

Department of Science and Technology1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
试验地点
1
主要终点
•Measurement of Alveolar Height and Width

研究概览

简要总结

This study is a randomized, parallel active-controlled trial assessing the extraction socket preservation using eggshell-derived nanohydroxyapatite graft with and without suture and will be conducted in the department of Clinical Research. The study subjects will be enrolled from the out-patient department of Oral and Maxillofacial Surgery. They will be randomly allocated into two groups and the consent will be obtained from the participants. The study participants will undergo atraumatic extraction. After achievement of post extraction hemostasis, nano-hydroxyapatite graft will be placed into the extraction socket till the crestal level and sutured using 3-0 black silk suture (figure of eight) in one group. In another group, nano-hydroxyapatite graft alone will be placed into the extraction socket till the crestal level. After the procedure, the subjects will be advised to follow post-extraction instructions. All the subjects will be followed up for 90 days for any adverse events and the parameters like soft tissue healing, pain and alveolar height and width will be assessed on 7th, 14th and 90th day post operatively.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18-45 years with physical status falling under the category of ASA I and II.
  • Patients undergoing atraumatic extraction for grossly decayed or non-restorable teeth or periodontally weakened teeth.
  • Subjects who are willing to take part in the study.

排除标准

  • Any abnormal findings during clinical or radiological examination.
  • Immunosuppressive conditions such as AIDS, Cancer or Radiation therapies.
  • Pregnant/Lactating women.

结局指标

主要结局

•Measurement of Alveolar Height and Width

时间窗: 1) On 7th day | 2) On 14th day | 3) On 90th day

•Soft Tissue Healing using Modified Laundry et al. Index

时间窗: 1) On 7th day | 2) On 14th day | 3) On 90th day

•Pain using Modified Wong-Baker Faces Pain Rating Scale

时间窗: 1) On 7th day | 2) On 14th day | 3) On 90th day

次要结局

  • Patient Comfort will be assessed after the procedure(7th, 14th and 90th day)

研究者

申办方类型
Government funding agency

研究点 (1)

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