Periodontal Inflammation and Wound Healing in Multiple Extractions

Four participants requiring multiple dental extractions will be recruited for this study. Two participants will be 21-50 years old, two participants 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.

Study Overview

• Status: Withdrawn
• Conditions: Wound Heal

Detailed Description

The purpose of this study is to better understand the cellular and immunological events occurring at various time points following dental tooth extractions as it relates to age of participants. Four participants requiring multiple extractions prior to denture fabrication will be enrolled: two will be younger than 50 years old, two will be older than 65. Inclusion criteria include: participants 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 participant's height and weight, gingival crevicular fluid sampling (GCF), HbA1c reading, saliva sampling peripheral blood draw and smoking status. Routine, atraumatic extraction of the teeth under local anesthetic will be performed. Following extraction, 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 participants 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 participants 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 time points in the wound healing process and variables of interest (age, gender, etc), clinical measures, including body mass index (BMI) and outcomes (endotypes, measures of healing).

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68583-0740
      • University of Nebraska Medical Center Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Four participants seeking multiple dental extractions; 21-50 years old, 65-80 years old.

Description

Inclusion Criteria:

• requires multiple dental extractions
• aged 21-50, 65-80 years old

Exclusion Criteria:

• history of systemic inflammatory diseases or medications

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Young (ages 21-50) requiring multiple extractions; Participants aged 21-50 requiring multiple extractions will be consented. These participants will undergo soft tissue, gingival crevicular fluid (GCF), venous blood sampling and cone beam commuted tomography (CBCT) analysis to determine age-related factors associated with post-extraction wound healing.
Old (ages 65-80) requiring multiple extractions; Participants aged 65-80 requiring multiple extractions will be consented. The older participants will undergo soft tissue, gingival crevicular fluid (GCF), venous blood sampling and cone beam commuted tomography (CBCT) analysis to determine age-related factors associated with post-extraction wound healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Cells	Presence or absence of inflammatory cells	Baseline, 1 week, 2 weeks, 3 weeks

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Amy C Killeen, DDS, MS, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Inflammation
• Other Study ID Numbers: 0886-23-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No