Periodontal Inflammation and Wound Healing in Multiple Extractions

NCT ID: NCT06185114

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2024-10-01

Brief Summary

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.

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).

Conditions

Wound Heal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• history of systemic inflammatory diseases or medications

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy C Killeen, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

0886-23-EP

Identifier Type: -

Identifier Source: org_study_id