A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography
研究概览
简要总结
To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
详细描述
AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
PRIMARY OBJECTIVE
Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.
SECONDARY OBJECTIVE
- Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
- Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
- Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participant, surgeon and assessors of the CBCT will be blinded to the treatment arm. The bone graft will be chosen at random from an envelope with a list generated by Sealed Envelope Ltd
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females ≥ 21 years of age
- •Able to provide informed consent
- •Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
- •Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
- •Presence of natural teeth adjacent to the tooth planned for extraction
- •Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
- •Dehiscence type defects of the sockets limited to 2/3rd length of the root
排除标准
- •Systemic conditions
- •Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
- •Conditions requiring chronic routine use of antibiotics or steroids
- •History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
- •Alcoholism or drug abuse and heavy smokers >10 cigarettes a day
- •Simultaneous participation in other studies
- •Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study
- •Local conditions
- •Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
- •Multi rooted teeth
- •Irradiation therapy
- •Osseous lesions
- •Missing teeth adjacent to the tooth being extracted
- •Implant restorations adjacent to the tooth being extracted
- •Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root
结局指标
主要结局
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography
时间窗: 6 months
Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction
次要结局
- Histologic analysis of bone biopsy cores(6 months)
- Horizontal dimensional changes measured intra-operatively using a Periodontal Probe(6 months)
- Vertical dimensional changes measured intra-operatively using a periodontal probe and stent(6 months)
研究者
Sejal Thacker
D.D.S., M.D.Sc., Graduate Program Director
UConn Health