Clinical trial NCT04805320: Association of Periodontal Inflammation on Immune Response in Wound Healing
Official title: Association of Periodontal Inflammation on Immune Response in Wound Healing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammation of Mouth
Keywords: periodontitis
wound healing
extraction
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults ages 21-70 with non-restorable posterior tooth requiring extraction.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* non-restorable posterior tooth (molar/premolar) in need of extraction

Exclusion Criteria:

* systemic disease that effects inflammation

Primary outcomes:
measure: Inflammatory cells
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska, College of Dentistry
state: Nebraska
Study officials:
affiliation: University of Nebraska, College of Dentistry
name: Joseph B Bavitz, DMD
role: STUDY_CHAIR
References: