Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06185114 |
| Other study ID # |
0886-23-EP |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2025 |
| Est. completion date |
February 1, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University of Nebraska |
| Contact |
Amy C Killeen, DDS, MS |
| Phone |
(402) 472-7848 |
| Email |
akilleen[@]unmc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Four subjects requiring multiple dental extractions will be recruited for this study. Two
subjects will be 21-50 years old, two subjects will be 65-80 years old. Following tooth
extractions, soft tissue sampling will be completed from the extraction sockets at baseline,
one week, two weeks and three weeks post-extraction. Soft tissue will be processed for sc-RNA
sequencing and/or flow cytometry to determine what cells, genomic pathways are present at
various timepoints during wound healing following dental extractions.
Description:
The purpose of this study is to better understand the cellular and immunological events
occuring at various timepoints following dental tooth extractions as it relates to age of
patient. Four subjects requiring multiple extractions prior to denture fabrication will be
enrolled in this study; two subjects will be younger than 50 years old, two subjects will be
older than 65. Inclusion criteria include: subjects seeking multiple tooth extractions due to
advanced bone loss or non-restorable teeth. Prior to tooth extraction, baseline clinical and
radiographic data will be collected; including subject's height and weight, gingival
crevicular fluid sampling, HbA1c reading, saliva sampling peripheral blood draw and smoking
status. Routine, atraumatic extraction of the teeth under local anesthetic will be performed.
Following extraction of the teeth, a 3 mm x 3 mm soft tissue sample will be collected from
one of the extraction sites and frozen/processed for sc-RNA sequencing and/or flow cytometry;
the extraction sites will be sutured closed. The subjects will return to clinic in one week's
time for suture removal and soft tissue sampling of an adjacent previously unsampled
extraction site under local anesthetic. The subjects will return to clinic in another week's
time (two weeks post-extraction) for a third soft tissue sample under local anesthetic from a
previously unsampled extraction site. All soft tissue samples will be processed for scRNA
sequencing and or flow cytometry. At all soft tissue sampling appointments, wound fluid will
be collected from the extraction sites and processed for biomarkers via multiplex. Saliva
samples will be frozen at time of sampling and will be frozen for multiplex evaluation. The
single blood draw will be processes via sc-RNA sequencing and/or flow cytometry to assess
presence of systemic immune cells. Final evaluation will be 3 months post-extraction and will
include clinical (PD, BOP, CAL) and radiographic (CBCT) data collection. Statistical analyses
will be completed to determine associations between various timepoints in the wound healing
process and variables of interest (age, gender, etc), clinical measures (including BMI) and
outcomes (endotypes, measures of healing).
