Tooth and Tissue Sample Collection During Wisdom Teeth Removal
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 16 - 50 |
| Updated: | 2/17/2019 |
| Start Date: | March 5, 2013 |
| End Date: | January 1, 2020 |
| Contact: | Sharon Mitchell |
| Email: | sharon.mitchell@nih.gov |
| Phone: | (301) 496-4372 |
Diagnosis and Treatment of Patients in Need of Third Molar Removal and Oral Specimen Acquisition
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.
- 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.
Objective
The objective of this protocol is to evaluate and provide treatment for subjects who have a
clinical indication for the routine extraction of dental third molar wisdom teeth with the
aim to allow investigators to maintain their expertise in dental clinical care, gain
additional knowledge about oral health and to utilize surgical waste collected from these
patients for research studies.
Study Population
The protocol will enroll a convenience sample of 1000 subjects ages greater than or equal to
16-50 in need of clinically indicated, routine extraction of third molars.
Design
This is an evaluation, treatment and training protocol. Subjects will receive standard
evaluation and treatment for clinically indicated, routine extraction of third molars.
Subjects will report to the NIDCR dental clinic for at least three visits. The first visit
will be a screening evaluation to determine the clinical need for third molar extraction and
protocol eligibility. Eligible subjects will return for a second visit for third molar
extraction. Oral specimens removed during the standard procedure of third molar extraction
will be distributed for research. A third visit will be scheduled approximately one week
after surgery for a post-operative clinical evaluation.
Outcome Measures
There is no research planned under this protocol. However, data is collected for purposes of
research and clinical quality assurance. If trends emerge that warrant further exploration,
outcome measures will be described when IRB approval or determination of exemption is
requested to carry out the project.
The objective of this protocol is to evaluate and provide treatment for subjects who have a
clinical indication for the routine extraction of dental third molar wisdom teeth with the
aim to allow investigators to maintain their expertise in dental clinical care, gain
additional knowledge about oral health and to utilize surgical waste collected from these
patients for research studies.
Study Population
The protocol will enroll a convenience sample of 1000 subjects ages greater than or equal to
16-50 in need of clinically indicated, routine extraction of third molars.
Design
This is an evaluation, treatment and training protocol. Subjects will receive standard
evaluation and treatment for clinically indicated, routine extraction of third molars.
Subjects will report to the NIDCR dental clinic for at least three visits. The first visit
will be a screening evaluation to determine the clinical need for third molar extraction and
protocol eligibility. Eligible subjects will return for a second visit for third molar
extraction. Oral specimens removed during the standard procedure of third molar extraction
will be distributed for research. A third visit will be scheduled approximately one week
after surgery for a post-operative clinical evaluation.
Outcome Measures
There is no research planned under this protocol. However, data is collected for purposes of
research and clinical quality assurance. If trends emerge that warrant further exploration,
outcome measures will be described when IRB approval or determination of exemption is
requested to carry out the project.
- INCLUSION CRITERIA:
- Ages greater than or equal to16-50
- Clinical evidence of need (dental decay, bony or soft tissue impaction, orthodontic
need) for third molar extraction as determined by medical, dental, and radiographic
evaluation
- Willing to allow for the collection of waste tissue (e.g., teeth, alveolar bone,
excessive gingival tissue) extracted 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
EXCLUSION CRITERIA:
- Pregnant or nursing women
- Known or suspected allergy or adverse reaction to any of the agents used for local
anesthesia, suture materials, or conscious sedation medications
- Known bleeding disorders or conditions associated with bleeding, including, but not
limited to, Hemophilia, von Willebrand disease, protein C/S deficiency, antithrombin
III deficiency, and liver disease
- Currently using anticoagulation (blood thinning) medications, including but not
limited to warfarin (Coumadin), ticlopidine (Ticlid) and clopidogril (Plavix)
- Clinical signs of infection (i.e. abscess) at the time of screening
- An anticipated difficult surgical removal of the third molars as evidenced by
panoramic radiographs. The following clinical findings would be evidence of probable
difficult surgical extractions:
- Increased depth of tooth impaction in bone
- Extreme angulations of the tooth
- Close proximity of the tooth to the inferior alveolar nerve canal and/or
maxillary sinus
- Medical history that would preclude outpatient conscious sedation setting for
extractions.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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