Wound HealNCT06185114
Periodontal Inflammation and Wound Healing in Multiple Extractions
An observational study of Wound Heal, run by University of Nebraska.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Four participants seeking multiple dental extractions; 21-50 years old, 65-80 years old.
Who may be able to join
- requires multiple dental extractions
- aged 21-50, 65-80 years old
Who cannot join
- history of systemic inflammatory diseases or medications
About this study
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Cells
Presence or absence of inflammatory cells
Measured: Baseline, 1 week, 2 weeks, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Why it stopped: Study no longer focus of laboratory/group of researchers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy C Killeen, DDS, MS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185114
- Sponsor's protocol ID
- 0886-23-EP
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2023
- Last updated
- 17 Mar 2025
- 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Inflammation and Wound Healing in Multiple Extractions
- ClinicalTrials.gov ID
- NCT06185114
- Acronym / sponsor ID
- 0886-23-EP
- Conditions
- Wound Heal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study no longer focus of laboratory/group of researchers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 29 Dec 2023 (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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Four participants seeking multiple dental extractions; 21-50 years old, 65-80 years old.
Key inclusion criteria (2 listed)
- requires multiple dental extractions
- aged 21-50, 65-80 years old
Key exclusion criteria (1 listed)
- history of systemic inflammatory diseases or medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory Cells
Time frame: Baseline, 1 week, 2 weeks, 3 weeks
Presence or absence of inflammatory cells
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- 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. This study is not recruiting at the moment.
Amy C Killeen, DDS, MS principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal, run by University of Nebraska.
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 2 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: withdrawn, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Cells (time frame: Baseline, 1 week, 2 weeks, 3 weeks). 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 17 Mar 2025.