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临床试验/NCT07394634
NCT07394634Enrolling By Invitation不适用

Evaluating the Efficacy of Autogenous Tooth Graft (ATG) Material in Socket Preservation: A Clinical and Radiographic Study.

Mahsa University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
20
试验地点
1
主要终点
Socket dimensional changes in autogenous tooth graft group and self healing group

研究概览

简要总结

This is the clinical trial. The goal of this clinical trial is to test whether self extracted tooth graft (autogenous tooth graft ) able to preserved the extraction socket effectively. Our aim is to answer is there any difference in dimensional changes in extraction socket in clinically and radiographically Researchers will compare autogenous tooth graft with self-healing extraction socket in radiographic and clinical measurement.

Participant will be randomly allocated into 2 groups ( Test or controlled group) Test group will be autogenous tooth grafting post extraction. After removed any caries, calculus and any gilling material, the extracted tooth will be grind with grinder and processed using BONMAKER machine. (which the bone graft is washed with hydrogen peroxide, hydrogen chloride and alcohol isopropyl) and controlled group will be self healing group. Both group will withdraw 20cc blood for PRF ( Plasma rich fibrin) membrane and place into the socket and secured with suture. They will be reviewed post extraction 1 week ( to ensure there is no infection ) , 2 week ( for suture removal ) , 1 months ( For clinical measurement) , 3 months (For clinical and radiographic measurement) and 6 months (For radiographic measurement).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> or equal to 18 years old
  • Presence of adjacent teeth to the extraction site
  • Healthy ,or well controlled systemic disease
  • Lower and upper incisors, lower premolar/ first molar
  • Full mouth plaque score < 15%
  • Adequate space for a dental implant restoration *Patient with previous diagnosis of periodontitis will be required to have a successfully completed course of periodontal treatment before enrolment.

排除标准

  • Smokers and vapers
  • Acute infection or sinus tract in relation to the tooth that require extraction
  • Pregnant or lactating women
  • Patient received antibiotic for past 1 month
  • Loss of more than 50% buccal or lingual /palatal bone at the time of extraction
  • Patient on medication that altered bone metabolism or bone healing such as bisphosphonates, chemotherapeutic drugs or immunosuppressive agents

研究组 & 干预措施

Self Healing Group

No Intervention

Self healing in extraction socket

Autogenous tooth graft

Experimental

Autogenous tooth grafting in extraction socket

干预措施: autogenous tooth graft (Procedure)

结局指标

主要结局

Socket dimensional changes in autogenous tooth graft group and self healing group

时间窗: 6 months

Socket dimensional changes will be measure in clinical and radiographic measure Clinical measure: A stent will be made prior extraction and hole on the stent will be made to standardized measurement. Clinical measurement ( socket height) will be measure during post extraction, 1 month, 3 month and 6 month to observe the value of the resorption of the extraction socket . The discrepancy value is will be from ( 1month -baseline, 3month-baseline, 6month- baseline) Radiographic measure: CBCT will be taken post extraction 3 month and 6month. Socket width will be measure in 3mm below the socket and 5 mm below the socket. Other than that, mimic software will be used for the volumetric changes.

次要结局

  • Volumetric changes in autogenous tooth group and self healing group(6 months)

研究者

发起方
Mahsa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lim Poh Ling

Dr

Mahsa University

研究点 (1)

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