跳至主要内容
临床试验/CTRI/2022/07/043959
CTRI/2022/07/043959尚未招募不适用

Evaluation of extraction socket healing with Naturally sourced (Eggshell derived) Nano-hydroxyapatite graft covered with Platelet Rich Fibrin (PRF) and extraction socket filled with Naturally sourced Nano-hydroxyapatite graft alone - 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
•Soft Tissue Healing using Modified Laundry et al. Index

研究概览

简要总结

This study is a randomized, parallel active controlled trial evaluating the healing of extraction socket with eggshell derived nanohydroxyapatite graft covered with platelet rich fibrin and eggshell derived nanohydroxyapatite graft alone and this study will be conducted in the department of Clinical Research.The study subjects will be enrolled from the out-patient department of Oral andMaxillofacial Surgery. They will be randomly allocated into two groups and theconsent will be obtained from the participants. The study participants willundergo atraumatic extraction. After achievement of post extraction hemostasis,nano-hydroxyapatite graft will be placed into the extraction socket till thecrestal level and PRF membrane will be placed over the grafted socket andtucked between Buccal and Lingual/Palatal gingiva and stabilized using 3-0black silk suture (figure of eight) in one group. In another group,nano-hydroxyapatite graft alone will be placed into extraction sockets up tothe crestal level and will be sutured using 3-0 black silk suture (figure ofeight). After the procedure, the subjects will be advised to follow postextraction instructions. All the subjects will be followed up for 90 days forany adverse events and the parameters like soft tissue healing, pain and alveolar width and height will be assessed on 7th, 14thand 90th day post operatively.

Preparation of Platelet Rich Fibrin (PRF) membrane: This will be prepared using autologous blood under standard asepticprecautions. Intravenous blood of 5 ml will be drawn from the precubital regionusing a sterile disposable syringe. Blood will be centrifuged using a tabletopcentrifuge for 10 minutes at 3000 rpm immediately. The resultant product willconsist of acellular plasma at the top, PRF clot in the middle, and red bloodcells at the bottom. PRF component will be separated and molded into a thinsheet of approximately 1x1 using a sterile wet gauze piece.

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

•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

•Measurement of Alveolar Height and Width

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

次要结局

  • Patient Comfort level will be assessed after the procedure on three time points(7th, 14th and 90th day)

研究者

申办方类型
Government funding agency

研究点 (1)

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