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RecruitingNCT04805320Updated Oct 8, 2026

Association of Periodontal Inflammation on Immune Response in Wound Healing

An observational study in Inflammation of Mouth, sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University of Nebraska · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 2 months later.
Updated Oct 8, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Twenty-five healthy adult subjects (aged 21-70) requiring extraction of a posterior tooth will be recruited for this study. Prior to extraction, a limited-view cone beam computed tomography radiograph will be taken as well as clinical measures of periodontal inflammation (probing depths, recession, bleeding on probing, gingival crevicular fluid sampling). The extraction will be completed atraumatically and with local anesthesia. Following extraction, a small biopsy of the soft tissue of the extraction site will be taken and the site then sutured. At the two-week postoperative visit, sutures will be removed and another soft tissue biopsy of the healing site will be collected (along with clinical data from the adjacent teeth). The soft tissue biopsies will be fixed and processed for inflammatory endocytes present during wound healing. At the three-month postoperative visit, all clinical parameters of wound healing will be evaluated; including inflammatory measures (probing depths, recession, bleeding on probing, gingival crevicular fluid sampling) from the adjacent teeth; as well as a limited-view cone beam computed tomography radiograph.

The biopsies will be processed to obtain single cell counts with half of the preparation stained and analyzed via multiparameter flow cytometry. The other half of single cells obtained from the tissue biopsies will be cryopreserved for cellular indexing of transcriptomes and epitopes-sequencing.

02

Conditions studied

  • Inflammation of Mouth

Keywords

  • periodontitis
  • wound healing
  • extraction
03

In context

Stomatitis

306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.

This study's planned enrollment of 25 is below the median of 75 across 20 observational studies indexed under Stomatitis.

Browse Stomatitis studies →

Lead sponsor

University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • systemic disease that effects inflammation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • ProcedureDental Extraction

    Extraction

06

What researchers measure

Primary outcomes

  1. Inflammatory cells

    Number of inflammatory cells present

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • University of Nebraska, College of Dentistry
    Lincoln, Nebraska 68583, United States
    Recruiting
    • Amy C Killeen, DDS, MS · Contactakilleen@unmc.edu · 402-472-7848
    • Amy C Killeen, DDS, MS · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Sep 2021 (actual). Primary completion is estimated for Jan 2027, 64 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Jun 2026 → Jan 2027 and completion Jul 2026 → Jan 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2021
First posted
Mar 18, 2021
StartActual
Sep 1, 2021
Primary completionEst.
Jan 2027was Jun 2026
CompletionEst.
Jan 1, 2027was Jul 2026
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jun 2026→Jan 2027
Oct 8, 2026
Study completion
Jul 2026→Jan 1, 2027
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Primary completion Jun 2026→Jan 2027
    Study completion Jul 2026→Jan 1, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04805320
Responsible party
Sponsor
First posted
Mar 18, 2021
Start date
Sep 1, 2021
Primary completion
Jan 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Amy C Killeen, DDS
Contact
akilleen@unmc.edu
402-472-7848
Joseph B Bavitz, DMD
study chair · University of Nebraska, College of Dentistry

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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