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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date July 1, 2026
Est. primary completion date June 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria: - non-restorable posterior tooth (molar/premolar) in need of extraction Exclusion Criteria: - systemic disease that effects inflammation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Dental Extraction
Extraction

Locations

Country Name City State
United States University of Nebraska, College of Dentistry Lincoln Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammatory cells Number of inflammatory cells present 3 months
See also
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Recruiting NCT02536781 - Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment Phase 2/Phase 3