Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal : Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
ObjectiveThe 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 PopulationThe protocol will enroll a convenience sample of 10000 subjects ages greater than or equal to 16-50 in need of clinically indicated, routine extraction of third molars.DesignThis 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. Data collection will include demographics, pain management, medication regimen and adverse events to examine its effect on clinical outcomesOutcome MeasuresThere 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..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 19. Apr. Zur Gesamtaufnahme - year:2024 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 6, 2013, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 |
|---|
| Study ID: |
NCT01805869 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG001411519 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG001411519 | ||
| 003 | DE-627 | ||
| 005 | 20240424010331.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210408s2024 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG001411519 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT01805869 | ||
| 035 | |a (UBBS_Klinische_Studien)130033 | ||
| 035 | |a (UBBS_Klinische_Studien)13-D-0033 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal |b Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: March 6, 2013, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 | ||
| 520 | |a ObjectiveThe 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 PopulationThe protocol will enroll a convenience sample of 10000 subjects ages greater than or equal to 16-50 in need of clinically indicated, routine extraction of third molars.DesignThis 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. Data collection will include demographics, pain management, medication regimen and adverse events to examine its effect on clinical outcomesOutcome MeasuresThere 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. | ||
| 650 | 2 | |a Tooth Diseases | |
| 650 | 2 | |a Tooth, Impacted | |
| 650 | 4 | |a Study Type: Observational | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 19. Apr. |
| 773 | 1 | 8 | |g year:2024 |g day:19 |g month:04 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT01805869 |x 0 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 19 |c 04 | ||