Severe PeriodontitisIFINCT03513497
IFI16 is a Periodontitis Modulating Protein
A study testing Customized acrylic mouthguard in people with Severe Periodontitis and Acute Inflammatory Response, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To characterize the expression of Interferon gamma inducible protein 16 (IFI16) and Absent in melanoma 2 (AIM2) in gingival tissues in an inflammatory response using an acrylic mouthguard (also referred to as a stent) induced bacteria overgrowth method. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Periodontitis, Acute Inflammatory Response
- What is being tested?
- Customized acrylic mouthguard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must have read, understood and signed an informed consent form.
- Subjects must be able and willing to follow study procedures and instructions.
- Subjects must be adult males or females with a minimum of 18 years (inclusive).
- Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
- Subjects must have at least 3 teeth in each posterior sextant
- Subjects must be in good general health
- Subjects must be in the healthy (PPC-A) or severe periodontitis (PPC-G) categories according to the PPC (1)
Who cannot join
- If the sextants identified for the analysis has implants
- All individuals who meet criteria for anti-infective prophylaxis prior to dental procedures
- Chronic disease with oral manifestations including diabetes mellitus.
- Current smoker or one that has stopped smoking less than 2 years prior to enrollment.
- Gross oral pathology other than the periodontal disease.
- Treatment with antibiotics for any medical or dental condition within 1 month prior to the screening examination.
Show all 18Show fewer
- Chronic treatment (i.e., two weeks or more) with any medication known to affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporin, coumadin, non-steroidal anti-inflammatory drugs, aspirin) within one month of the screening examination.
- Ongoing medications initiated less than three months prior to enrollment (i.e., medications for chronic medical conditions must be initiated at least three months prior to enrollment).
- Significant organ disease including impaired renal function, heart murmur, history of rheumatic fever or valvular disease, or any bleeding disorder.
- Individuals with prosthetic material used for intra-cardiac repair (e.g. for congenital heart disease), or intra-cardiac devices, cardiac transplant, infective endocarditis and individuals who have had previous infectious complications of prosthetic joint infections
- Infectious diseases such as hepatitis, HIV or tuberculosis.
- Anemia or other blood dyscrasias.
- Anticoagulant therapy or drugs, such as heparin or warfarin.
- Severe unrestored caries, or any condition that is likely to require antibiotic treatment over the trial.
- Pregnant, or expect to become pregnant within the next several months.
- Females of child-bearing capacity must be willing to have pregnancy test to confirm they are not pregnant.
- Females of child-bearing capacity not using any form of contraceptive methods
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
To characterize the expression of Interferon gamma inducible protein 16 (IFI16) and Absent in melanoma 2 (AIM2) in gingival tissues in an inflammatory response using an acrylic mouthguard (also referred to as a stent) induced bacteria overgrowth method.
Participants: A maximum of 72 Adult subjects will be recruited from the patients, students and staff at the University of North Carolina, as well as the general population in or near Chapel Hill NC.
Read more
Procedures (methods):
Medical history, demographics, (height/weight), urine based pregnancy test, vital signs (to include blood pressures, and pulse) standard dental clinical measures (to include plaque index, gingival index, bleeding on probing, and clinical attachment level), alginate impressions taken for fabrication of an acrylic stent (mouthguard), 2 gingival biopsies, 2 subgingival (below the gumline) plaque samples, and Scaling Root planing (SRP)/or adult prophylaxis
Read the detailed description
A total of 72 subjects will be enrolled. Specifically, a sufficient number of adults 18 years and older will be screened until 36 healthy (PPC-A) subjects and 36 subjects with severe periodontal disease (PPC-G) will be enrolled. Eligibility for study participation will be determined during the screening session. Barring dropout, subject participation will include 1 to 8 visits lasting over a maximum period of 42 days. The last 3 visits (visit 5-8) will depend on the individual need of the subject for providing SRP. Clinical data and medical history data will be collected at the screening visit to ascertain eligibility. All subjects will have dental plaque and a gingival biopsy collected at baseline. Enrolled subjects will be included in an experimental gingivitis model Stent-Induced Biofilm Overgrowth (SIBO) for 21 days. Individuals will return for safety checks every week during the 21-day period. At 21-days, plaque samples and a gingival biopsy will be collected. For diseased individuals SRP will initiate during the 21-day visit at the SIBO quadrant. Visit 6 (28 days) will include the post-biopsy follow up, prophylaxis (for healthy individuals) and SRP (diseased individuals). Subjects receiving SRP may have 2 additional visits (visit 7 at day 35 and visit 8 at day 42) for completing the SRP of all quadrants and will be dependent on individual need. Medical histories, demographics, height and weight, clinical and biological data described above will be recorded and stored on a secure server located at the University of North Carolina. Each participant enrolled into the study will have a unique identification number that has been stripped of any information that could be used by non-study members to identify the subject.
- Conditions
- Severe Periodontitis, Acute Inflammatory Response
- Being tested
- Customized acrylic mouthguard
- Keywords
- Teeth, Periodontal disease, acute inflammatory response, stent-induced biofilm overgrowth, periodontal pathogens
- Medical subject headings
- Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized acrylic mouthguardOther
Also called intraoral stent
Customized acrylic mouthguards extended to cover approximately 2 mm over gingival margins will be fabricated for each subject. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will cover the area in one sextant where no brushing and flossing teeth is to occur for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal Profile Class (PPC-A) | Experimental | Periodontally healthy participants (PPC-A) and participants with mild disease (PPC-B) will wear customized acrylic mouthguard only during tooth brushing for 21 days. Receives: Other: Customized acrylic mouthguard |
| Periodontal Profile Class (PPC-G) | Experimental | Participants with severe periodontal disease (PPC-G) and participants with posterior disease (PPC-E) will wear customized acrylic mouthguard only during tooth brushing for 21 days. Receives: Other: Customized acrylic mouthguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels
Gingival tissues derived from study participants were evaluated for AIM2 mRNA expression at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Gene expression was evaluated by quantitative reverse transcription polymerase chain reaction (qRT-PCR) and quantified by the delta-delta-CT method.
Measured: Baseline (Day 0), Visit 5 (Day 21)
Change in Interferon Gamma Inducible Protein 16 (IFI16) mRNA Expression Levels
Gingival tissues derived from study participants were evaluated for IFI16 mRNA expression at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Gene expression was evaluated by qRT-PCR and quantified by the delta-delta-CT method.
Measured: Baseline (Day 0), Visit 5 (Day 21)
Change in the Percentage of AIM2 Positive Cells
Gingival tissues derived from study participants were evaluated for AIM2 immunohistochemical staining at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Cell positivity at baseline and Day 21 was measured by H-score, which consists of (percent low positive cells x 1) + (percent positive cells x 2) + (percent high positive cells x 3).
Measured: Baseline (Day 0), Visit 5 (Day 21)
Change in Percentage of Interferon Gamma Inducible Protein 16 (IFI16) Positive Cells
Gingival tissues derived from study participants were evaluated for IFI16 immunohistochemical staining at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Cell positivity at baseline and Day 21 was measured by H-score, which consists of (percent low positive cells x 1) + (percent positive cells x 2) + (percent high positive cells x 3).
Measured: Baseline (Day 0), Visit 5 (Day 21)
Secondary outcomes (2)
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Correlation between temporal changes in periodontal pathogen levels that are statistically significant between Day 0 and Day 21 were correlated with temporal changes in AIM2 expression using Spearman rank correlation coefficients and corresponding 95% confidence intervals.
Measured: Baseline (Day 0), Visit 5 (Day 21)
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Correlation between temporal changes in periodontal pathogen levels that are statistically significant between Day 0 and Day 21 were correlated with temporal changes in IFI16 expression using Spearman rank correlation coefficients and corresponding 95% confidence intervals.
Measured: Baseline (Day 0), Visit 5 (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start18 Oct 2018
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe PeriodontitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Julie T Marchesan, DDS, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513497
- Sponsor's protocol ID
- 18-0291
- Other IDs
- 1K01DE027087-01
- Acronym
- IFI
- Status last verified
- May 2024
- First submitted
- 19 Apr 2018
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFI16 is a Periodontitis Modulating Protein
- ClinicalTrials.gov ID
- NCT03513497
- Acronym / sponsor ID
- IFI / 18-0291
- Conditions
- Severe Periodontitis, Acute Inflammatory Response
- Keywords
- Teeth, Periodontal disease, acute inflammatory response, stent-induced biofilm overgrowth, periodontal pathogens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the expression of Interferon gamma inducible protein 16 (IFI16) and Absent in melanoma 2 (AIM2) in gingival tissues in an inflammatory response using an acrylic mouthguard (also referred to as a stent) induced bacteria overgrowth method.
Participants: A maximum of 72 Adult subjects will be recruited from the patients, students and staff at the University of North Carolina, as well as the general population in or near Chapel Hill NC.
Procedures (methods):
Medical history, demographics, (height/weight), urine based pregnancy test, vital signs (to include blood pressures, and pulse) standard dental clinical measures (to include plaque index, gingival index, bleeding on probing, and clinical attachment level), alginate impressions taken for fabrication of an acrylic stent (mouthguard), 2 gingival biopsies, 2 subgingival (below the gumline) plaque samples, and Scaling Root planing (SRP)/or adult prophylaxis
Detailed description
A total of 72 subjects will be enrolled. Specifically, a sufficient number of adults 18 years and older will be screened until 36 healthy (PPC-A) subjects and 36 subjects with severe periodontal disease (PPC-G) will be enrolled. Eligibility for study participation will be determined during the screening session. Barring dropout, subject participation will include 1 to 8 visits lasting over a maximum period of 42 days. The last 3 visits (visit 5-8) will depend on the individual need of the subject for providing SRP. Clinical data and medical history data will be collected at the screening visit to ascertain eligibility. All subjects will have dental plaque and a gingival biopsy collected at baseline. Enrolled subjects will be included in an experimental gingivitis model Stent-Induced Biofilm Overgrowth (SIBO) for 21 days. Individuals will return for safety checks every week during the 21-day period. At 21-days, plaque samples and a gingival biopsy will be collected. For diseased individuals SRP will initiate during the 21-day visit at the SIBO quadrant. Visit 6 (28 days) will include the post-biopsy follow up, prophylaxis (for healthy individuals) and SRP (diseased individuals). Subjects receiving SRP may have 2 additional visits (visit 7 at day 35 and visit 8 at day 42) for completing the SRP of all quadrants and will be dependent on individual need. Medical histories, demographics, height and weight, clinical and biological data described above will be recorded and stored on a secure server located at the University of North Carolina. Each participant enrolled into the study will have a unique identification number that has been stripped of any information that could be used by non-study members to identify the subject.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontal Profile Class (PPC-A) | Experimental | Other: Customized acrylic mouthguardPeriodontally healthy participants (PPC-A) and participants with mild disease (PPC-B) will wear customized acrylic mouthguard only during tooth brushing for 21 days. |
| Periodontal Profile Class (PPC-G) | Experimental | Other: Customized acrylic mouthguardParticipants with severe periodontal disease (PPC-G) and participants with posterior disease (PPC-E) will wear customized acrylic mouthguard only during tooth brushing for 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must have read, understood and signed an informed consent form.
- Subjects must be able and willing to follow study procedures and instructions.
- Subjects must be adult males or females with a minimum of 18 years (inclusive).
- Subjects must present with at least 20 teeth in the functional dentition, excluding third molars.
- Subjects must have at least 3 teeth in each posterior sextant
Key exclusion criteria (18 listed)
- If the sextants identified for the analysis has implants
- All individuals who meet criteria for anti-infective prophylaxis prior to dental procedures
- Chronic disease with oral manifestations including diabetes mellitus.
- Current smoker or one that has stopped smoking less than 2 years prior to enrollment.
- Gross oral pathology other than the periodontal disease.
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 |
|---|---|---|
| Customized acrylic mouthguardAlso: intraoral stentCustomized acrylic mouthguards extended to cover approximately 2 mm over gingival margins will be fabricated for each subject. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will cover the area in one sextant where no brushing and flossing teeth is to occur for 21 days. | Other | Periodontal Profile Class (PPC-A), Periodontal Profile Class (PPC-G) |
Primary outcome
Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels
Time frame: Baseline (Day 0), Visit 5 (Day 21)
Gingival tissues derived from study participants were evaluated for AIM2 mRNA expression at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Gene expression was evaluated by quantitative reverse transcription polymerase chain reaction (qRT-PCR) and quantified by the delta-delta-CT method.
Change in Interferon Gamma Inducible Protein 16 (IFI16) mRNA Expression Levels
Time frame: Baseline (Day 0), Visit 5 (Day 21)
Gingival tissues derived from study participants were evaluated for IFI16 mRNA expression at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Gene expression was evaluated by qRT-PCR and quantified by the delta-delta-CT method.
Change in the Percentage of AIM2 Positive Cells
Time frame: Baseline (Day 0), Visit 5 (Day 21)
Gingival tissues derived from study participants were evaluated for AIM2 immunohistochemical staining at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Cell positivity at baseline and Day 21 was measured by H-score, which consists of (percent low positive cells x 1) + (percent positive cells x 2) + (percent high positive cells x 3).
Change in Percentage of Interferon Gamma Inducible Protein 16 (IFI16) Positive Cells
Time frame: Baseline (Day 0), Visit 5 (Day 21)
Gingival tissues derived from study participants were evaluated for IFI16 immunohistochemical staining at baseline (experimental timepoint named Day 0) and at 21 days (experimental timepoint named Day 21). Cell positivity at baseline and Day 21 was measured by H-score, which consists of (percent low positive cells x 1) + (percent positive cells x 2) + (percent high positive cells x 3).
2 secondary outcomes
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Time frame: Baseline (Day 0), Visit 5 (Day 21)
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Time frame: Baseline (Day 0), Visit 5 (Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and executes a data use/sharing agreement with UNC.
Related trials for Severe Periodontitis
Not yet recruiting
Clinical Effectiveness of Oxygen-Releasing Oral Gel as an Adjunct to Scaling and Root Debridement in Patients With Severe Periodontal Pockets: A Randomized Clinical Trial
Periodontitis
Recruiting
Comparative Effects of Two Oral Antiseptics Used as an Adjuvant in the Treatment of Periodontitis
Periodontitis, Periodontitis Stage II
Not yet recruitingPhase 2
Efficacy and Safety of LP-005 Injection in Patients With Moderate-to-Severe Periodontitis
Periodontitis
Not yet recruitingObservational study
Development and Validation of the Periodontal Map Derived From IOS and CBCT Registration for Diagnosis and Treatment Planning in Moderate-to-severe Periodontitis
Periodontitis Stage II, Periodontitis Stage III
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
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.
Julie T Marchesan, DDS, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized acrylic mouthguard in people with Severe Periodontitis and Acute Inflammatory Response, run by University of North Carolina, Chapel Hill 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 7 inclusion and 18 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: finished, as of the sponsor's last update on 3 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels (time frame: Baseline (Day 0), Visit 5 (Day 21)). The study lists 4 primary outcomes in all. 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 3 Jul 2024.