N/A
N=69
IFI16 is a Periodontitis Modulating Protein
Severe Periodontitis · Acute Inflammatory Response
Bottom Line
View on ClinicalTrials.gov: NCT03513497 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels — 0.37; 0.65 fold change — p=0.3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Customized acrylic mouthguard (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels |
0.37; 0.65 | 0.3 |
| PRIMARY Change in Interferon Gamma Inducible Protein 16 (IFI16) mRNA Expression Levels |
0.07; 0.10 | 0.5 |
| PRIMARY Change in the Percentage of AIM2 Positive Cells |
-0.71; 4.55 | 0.6 |
| PRIMARY Change in Percentage of Interferon Gamma Inducible Protein 16 (IFI16) Positive Cells |
0.91; 5.46 | 0.5 |
| SECONDARY Correlation of Changes in Periodontal Pathogens With Changes of AIM2 |
-0.1; -0.1; -0.2; 0.28; 0.3; -0.16 | — |
| SECONDARY Correlation of Changes in Periodontal Pathogens With Changes of IFI16 |
-0.3; -0.3; -0.36; 0.4; 0.2; -0.2 | — |
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.
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
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03513497). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.