NCT04805320

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Sep 2021Jul 2026

First Submitted

Initial submission to the registry

March 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

March 16, 2021

Last Update Submit

December 2, 2025

Conditions

Inflammation of Mouth

Keywords

periodontitiswound healingextraction

Outcome Measures

Primary Outcomes (1)

  • Inflammatory cells

    Number of inflammatory cells present

    3 months

Interventions

Dental ExtractionPROCEDURE

Extraction

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults ages 21-70 with non-restorable posterior tooth requiring extraction.

You may qualify if:

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

You may not qualify if:

  • systemic disease that effects inflammation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska, College of Dentistry

Lincoln, Nebraska, 68583, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Soft tissue biopsies will be cryopreserved and prepared for ssRNA sequencing

MeSH Terms

Conditions

StomatitisPeriodontitis

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontal Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Joseph B Bavitz, DMD

    University of Nebraska, College of Dentistry

    STUDY CHAIR

Central Study Contacts

Amy C Killeen, DDS

CONTACT

402-472-7848akilleen@unmc.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 18, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)