Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04805320 |
| Other study ID # |
0257-21-FB |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
July 1, 2026 |
Study information
| Verified date |
June 2024 |
| Source |
University of Nebraska |
| Contact |
Amy C Killeen, DDS |
| Phone |
402-472-7848 |
| Email |
akilleen[@]unmc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Subjects who are in need of extraction of a posterior tooth will be recruited for this study.
Prior to extraction, periodontal clinical markers of inflammation, body-mass index and dental
radiographs will be measured/taken. The posterior tooth will be atraumatically extracted and
a small soft tissue biopsy of the extraction site will be taken. At the two week follow-up,
sutures will be removed and another small biopsy of soft tissue will be taken. Subjects will
be seen again at 3 months for a final collection of clinical data and radiographs.
Description:
Twenty-five healthy adult subjects (aged 21-70) requiring extraction of a posterior tooth
will be recruited for this study. Prior to extraction, a limited-view cone beam computed
tomography radiograph will be taken as well as clinical measures of periodontal inflammation
(probing depths, recession, bleeding on probing, gingival crevicular fluid sampling). The
extraction will be completed atraumatically and with local anesthesia. Following extraction,
a small biopsy of the soft tissue of the extraction site will be taken and the site then
sutured. At the two-week postoperative visit, sutures will be removed and another soft tissue
biopsy of the healing site will be collected (along with clinical data from the adjacent
teeth). The soft tissue biopsies will be fixed and processed for inflammatory endocytes
present during wound healing. At the three-month postoperative visit, all clinical parameters
of wound healing will be evaluated; including inflammatory measures (probing depths,
recession, bleeding on probing, gingival crevicular fluid sampling) from the adjacent teeth;
as well as a limited-view cone beam computed tomography radiograph.
The biopsies will be processed to obtain single cell counts with half of the preparation
stained and analyzed via multiparameter flow cytometry. The other half of single cells
obtained from the tissue biopsies will be cryopreserved for cellular indexing of
transcriptomes and epitopes-sequencing.
