Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06185114
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-12-11
Brief Title:
Periodontal Inflammation and Wound Healing in Multiple Extractions
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Periodontal Inflammation and Wound Healing in Multiple Extractions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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 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 subjects 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 frozenprocessed for sc-RNA sequencing andor flow cytometry the extraction sites will be sutured closed The subjects will return to clinic in one weeks 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 weeks 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None