Periodontal Inflammation and Wound Healing in Multiple Extractions

Wound Heal Clinical Trial

Official title: Periodontal Inflammation and Wound Healing in Multiple Extractions

Status Not yet recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Inflammation
• Wound Heal
• Wounds and Injuries

• NCT number: NCT06185114
• Study type: Observational
• Source: University of Nebraska
• Contact: Amy C Killeen, DDS, MS
• Phone: (402) 472-7848
• Email: akilleen@unmc.edu
• Status: Not yet recruiting
• Start date: January 1, 2025
• Completion date: February 1, 2026