Inflammation of MouthNCT04805320
Association of Periodontal Inflammation on Immune Response in Wound Healing
An observational study of Inflammation of Mouth, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation of Mouth
- What is being tested?
- Dental Extraction
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults ages 21-70 with non-restorable posterior tooth requiring extraction.
Who may be able to join
- non-restorable posterior tooth (molar/premolar) in need of extraction
Who cannot join
- systemic disease that effects inflammation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska, College of Dentistry
Lincoln, Nebraska, 68583
Amy C Killeen, DDS, MS, 402-472-7848, akilleen@unmc.edu
Amy C Killeen, DDS, MS
About this study
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.
- Conditions
- Inflammation of Mouth
- Being tested
- Dental Extraction
- Keywords
- periodontitis, wound healing, extraction
- Medical subject headings
- Stomatitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental ExtractionProcedure or surgery
Extraction
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory cells
Number of inflammatory cells present
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Sep 2021
- Primary completionJan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation of MouthStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph B Bavitz, DMD, Study chair, University of Nebraska, College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805320
- Sponsor's protocol ID
- 0257-21-FB
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2021
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Periodontal Inflammation on Immune Response in Wound Healing
- ClinicalTrials.gov ID
- NCT04805320
- Acronym / sponsor ID
- 0257-21-FB
- Conditions
- Inflammation of Mouth
- Keywords
- periodontitis, wound healing, extraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults ages 21-70 with non-restorable posterior tooth requiring extraction.
Key inclusion criteria (1 listed)
- non-restorable posterior tooth (molar/premolar) in need of extraction
Key exclusion criteria (1 listed)
- systemic disease that effects inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental ExtractionExtraction | Procedure or surgery | – |
Primary outcome
Inflammatory cells
Time frame: 3 months
Number of inflammatory cells present
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph B Bavitz, DMD study chair
University of Nebraska, College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation of Mouth, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy C Killeen, DDS (402-472-7848, akilleen@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory cells (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.