Wisdom TeethNCT00316485
Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
An observational study of Wisdom Teeth, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial summary
Under this study, patients who require removal of their third molars (wisdom teeth) will be diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be collected for use in bone, wound healing, microbiology and genetic research. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Wisdom Teeth
- How many people
- 718 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2006to 28 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- <TAB>
- Males and females aged 18 to 50 years
- Evidence of need for third molar extraction as determined by medical and dental history, as well as clinical and radiographic evaluation
- Willing to provide at least one wisdom tooth for research purposes
- Willing to provide one or more of the following tissue types for research purposes:
- Excessive gingival tissue around extraction sockets
Show all 9Show fewer
- Oral tissues from the floor of the mouth, cheek, palate and/or lateral border of the tongue
- Small biopsies of alveolar bone from the sockets that surround the wisdom teeth
- America Society of Anesthesiologists (ASA) status I or II
Who cannot join
- Pregnant or nursing
- Clinical signs of infection and/or inflammation, or acute pain at any extraction site at the time of the screening evaluation
- Known bleeding disorders or conditions associated with bleeding, including 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). Subjects who are currently taking Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) may be eligible for enrollment.
- Known or suspected allergy or adverse reaction to any of the agents used for local anesthesia, suture material, or conscious sedation medications
- Surgical removal of the wisdom teeth is expected to be unusually difficult based on panoramic radiograph. Indicators of unusual difficulty include increased depth of tooth impaction, extreme angulation of a tooth, and close proximity of a tooth to the inferior alveolar nerve canal and/or maxillary sinus.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Under this study, patients who require removal of their third molars (wisdom teeth) will be diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be collected for use in bone, wound healing, microbiology and genetic research.
Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study. Participants may have one or all of their wisdom teeth removed at one time. The surgery is done under local anesthetic. In addition, conscious sedation may be administered, if the patient wishes.
Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from the lining of the inner wall of the tooth socket) and gum tissue (from the area of the surgical site). The samples are collected at the same time as the tooth extraction. The bone sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and the gum tissue sample is 1 millimeter. Removal of these samples should not cause any additional discomfort or increase the time required for the surgery or for healing.
Read the detailed description
OBJECTIVE:
The objective of this protocol is to obtain oral tissue for analysis by various research groups at the National Institutes of Health (NIH).
STUDY POPULATION:
The protocol will enroll a convenience sample of 1,000 subjects between the ages of 18 to 50 years who are in need of third molar (wisdom tooth) extraction.
STUDY DESIGN:
Subjects will report to the National Institutes of Dental and Craniofacial Research (NIDCR) for up to three visits. The first study visit will involve a screening evaluation to determine protocol eligibility. Eligible subjects will be invited back for a second visit for wisdom tooth extraction and collection of oral tissue for research purposes. All subjects will remain on the protocol for three weeks after surgery, and they will have the option to schedule a follow-up visit to the NIH for post-operative evaluation.
OUTCOME MEASURES:
This study does not involve any outcome measurements.
- Conditions
- Wisdom Teeth
- Keywords
- Bone, Microbiology, Dental Pulp Stem Cell, Wisdom Teeth, Biopsy, Third Molar Extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study start14 Apr 2006
- Study completion28 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wisdom TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Carol W Bassim, D.M.D., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316485
- Sponsor's protocol ID
- 060144
- Other IDs
- 06-D-0144
- Status last verified
- 28 Jan 2013
- First submitted
- 19 Apr 2006
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Foster JS, Palmer RJ Jr, Kolenbrander PE. Human oral cavity as a model for the study of genome-genome interactions. Biol Bull. 2003 Apr;204(2):200-4. doi: 10.2307/1543559.
PubMed 12700154Palmer RJ Jr, Gordon SM, Cisar JO, Kolenbrander PE. Coaggregation-mediated interactions of streptococci and actinomyces detected in initial human dental plaque. J Bacteriol. 2003 Jun;185(11):3400-9. doi: 10.1128/JB.185.11.3400-3409.2003.
PubMed 12754239Kolenbrander PE, Egland PG, Diaz PI, Palmer RJ Jr. Genome-genome interactions: bacterial communities in initial dental plaque. Trends Microbiol. 2005 Jan;13(1):11-5. doi: 10.1016/j.tim.2004.11.005.
PubMed 15639626
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis, Evaluation and Treatment of Patients in Need of Third Molar Removal
- ClinicalTrials.gov ID
- NCT00316485
- Acronym / sponsor ID
- 060144
- Conditions
- Wisdom Teeth
- Keywords
- Bone, Microbiology, Dental Pulp Stem Cell, Wisdom Teeth, Biopsy, Third Molar Extraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 14 Apr 2006
- Study completion
- 28 Jan 2013
- First posted
- 20 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Under this study, patients who require removal of their third molars (wisdom teeth) will be diagnosed, evaluated and treated. In addition, tooth, bone and gum tissue samples will be collected for use in bone, wound healing, microbiology and genetic research.
Patients 16-50 years of age who require wisdom tooth removal may be eligible for this study. Participants may have one or all of their wisdom teeth removed at one time. The surgery is done under local anesthetic. In addition, conscious sedation may be administered, if the patient wishes.
Besides wisdom tooth removal, patients are asked to donate a small sample of jaw bone (from the lining of the inner wall of the tooth socket) and gum tissue (from the area of the surgical site). The samples are collected at the same time as the tooth extraction. The bone sample is about the size of a pencil point (1.5 millimeters wide and 3 millimeters long) and the gum tissue sample is 1 millimeter. Removal of these samples should not cause any additional discomfort or increase the time required for the surgery or for healing.
Detailed description
OBJECTIVE:
The objective of this protocol is to obtain oral tissue for analysis by various research groups at the National Institutes of Health (NIH).
STUDY POPULATION:
The protocol will enroll a convenience sample of 1,000 subjects between the ages of 18 to 50 years who are in need of third molar (wisdom tooth) extraction.
STUDY DESIGN:
Subjects will report to the National Institutes of Dental and Craniofacial Research (NIDCR) for up to three visits. The first study visit will involve a screening evaluation to determine protocol eligibility. Eligible subjects will be invited back for a second visit for wisdom tooth extraction and collection of oral tissue for research purposes. All subjects will remain on the protocol for three weeks after surgery, and they will have the option to schedule a follow-up visit to the NIH for post-operative evaluation.
OUTCOME MEASURES:
This study does not involve any outcome measurements.
Study design
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- <TAB>
- Males and females aged 18 to 50 years
- Evidence of need for third molar extraction as determined by medical and dental history, as well as clinical and radiographic evaluation
- Willing to provide at least one wisdom tooth for research purposes
- Willing to provide one or more of the following tissue types for research purposes:
Key exclusion criteria (6 listed)
- Pregnant or nursing
- Clinical signs of infection and/or inflammation, or acute pain at any extraction site at the time of the screening evaluation
- Known bleeding disorders or conditions associated with bleeding, including 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). Subjects who are currently taking Aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) may be eligible for enrollment.
- Known or suspected allergy or adverse reaction to any of the agents used for local anesthesia, suture material, or conscious sedation medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 12700154Foster JS, Palmer RJ Jr, Kolenbrander PE. Human oral cavity as a model for the study of genome-genome interactions. Biol Bull. 2003 Apr;204(2):200-4. doi: 10.2307/1543559.
- Background: PubMed 12754239Palmer RJ Jr, Gordon SM, Cisar JO, Kolenbrander PE. Coaggregation-mediated interactions of streptococci and actinomyces detected in initial human dental plaque. J Bacteriol. 2003 Jun;185(11):3400-9. doi: 10.1128/JB.185.11.3400-3409.2003.
- Background: PubMed 15639626Kolenbrander PE, Egland PG, Diaz PI, Palmer RJ Jr. Genome-genome interactions: bacterial communities in initial dental plaque. Trends Microbiol. 2005 Jan;13(1):11-5. doi: 10.1016/j.tim.2004.11.005.
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Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
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A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol W Bassim, D.M.D. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wisdom Teeth, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00316485, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.