Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- data collection
研究概览
简要总结
Background:
- The third molars (wisdom teeth) normally grow in during late adolescence or early adulthood. Many people need or choose to have these teeth removed with oral surgery. Normally, the removed teeth and tissue are thrown away as medical waste. However, oral health researchers want to collect the teeth and tissue for research. They also want to encourage dentists at the National Institutes of Health to improve their skills in oral surgery. This study will collect the teeth and tissue of people who need to have oral surgery to remove their wisdom teeth.
Objectives:
- To provide continued dental skills training for dentists at the National Institutes of Health.
- To collect teeth and tissue samples following wisdom tooth removal surgery.
Eligibility:
- Individuals between 16 and 50 who need to have their wisdom teeth removed.
Design:
- This study will involve a minimum of three visits. There will be a screening visit, a surgery visit, and at least one follow-up visit.
- Participants will be screened with a physical exam and medical history. A full dental exam with x-rays will be given to evaluate the need for surgery.
- At the second visit, participants will have oral surgery to remove their wisdom teeth. The teeth and tissue removed during the surgery will be collected for study.
- Participants will receive drugs to control the pain after surgery. They will also be able to contact a dentist if there are any problems.
- Between 7 and 21 days after surgery, participants will have a followup visit to check the healing. If they are having no problems, this will be the last visit. If there are any postsurgery issues, they will be scheduled for additional visits as needed.
详细描述
Objective
The objective of this protocol is to collect data and surgical waste tissue for research purpose in subjects undergoing clinically indicated wisdom teeth extraction at the NIH NIDCR Dental clinic with the aim of obtaining generalizable knowledge about oral health while utilizing surgical waste tissue for research studies.
Study Population
The protocol will enroll a convenience sample of 3,000 subjects ages greater than or equal to 16-50 in need of clinically indicated extraction of third molars.
Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Ages greater than or equal to 16-50 years
- •Clinical evidence of need for third molar extraction as determined by medical, dental, and radiographic evaluation by a NIDCR oral surgeon
- •Willing to allow for the collection of extracted waste tissue (e.g., teeth, alveolar bone, excessive gingival tissue) to be used for research
- •In good general health as defined by the American Society of Anesthesiologists (ASA) status I or II
- •Able to understand and sign an informed consent
排除标准
- •Pregnant or nursing women
- •Unable to have third molar extraction as determined by NIDCR surgeon/dentist, due to medical conditions (beyond ASA I or II), complexity of the surgery, or history that precludes safe outpatient conscious sedation. These clinical decisions will be based on the risks and benefits related to the surgery.
研究组 & 干预措施
Healthy volunteers
Male or female ages 16-50
结局指标
主要结局
data collection
时间窗: 16 years
If trends emerge that warrant further exploration, outcome measures will be described
次要结局
未报告次要终点