IFI16 is a Periodontitis Modulating Protein (IFI)

• ClinicalTrials.gov Identifier: NCT03513497
• Recruitment Status: Recruiting
• First Posted: May 1, 2018
• Last Update Posted: April 8, 2021
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

Brief Summary:

To characterize the expression of IFI16 and 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

Condition or disease	Intervention/treatment	Phase
Severe Periodontitis; Acute Inflammatory Response	Other: Customized acrylic mouthguard	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: IFI16 is a Periodontitis Modulating Protein
• Actual Study Start Date: October 18, 2018
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: June 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Periodontal Profile Class (PPC-A); Periodontally healthy participants (PPC-A) will wear customized acrylic mouthguard only during tooth brushing for 21 days.	Other: Customized acrylic mouthguard; 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.; Other Name: intraoral stent
Experimental: Periodontal Profile Class (PPC-G); Participants with severe periodontal disease (PPC-G) will wear customized acrylic mouthguard only during tooth brushing for 21 days.	Other: Customized acrylic mouthguard; 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.; Other Name: intraoral stent

Outcome Measures

Primary Outcome Measures :

1. Mean AIM2 mRNA fold change [ Time Frame: Baseline (Day 0), Visit 5 (Day 21) ]
2. Mean IFI16 mRNA fold change [ Time Frame: Baseline (Day 0), Visit 5 (Day 21) ]
3. Percentage of SIBO-induced AIM2 positive cells [ Time Frame: Baseline (Day 0), Visit 5 (Day 21) ]
4. Percentage of SIBO-induced IIFI16 M2 positive cells [ Time Frame: Baseline (Day 0), Visit 5 (Day 21) ]

Secondary Outcome Measures :

1. Percent periodontal pathogens by expression of AIM2 and IFI16 [ Time Frame: Baseline (Day 0), Visit 5 (Day 21) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Kristy M Williams, BS; 919-537-3420; kristyw@email.unc.edu

Contact: Sherrill T Phillips, BS; 919-537-3422; sherrill_Phillips@unc.edu

Locations

United States, North Carolina

University of North Carolina at Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Kristy Williams, BS 919-818-4649 kristyw@email.unc.edu

Contact: Sherrill T Phillips, BS 919-537-3422 sherrill_phillips@unc.edu

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: Julie T Marchesan, DDS, PhD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03513497
• Other Study ID Numbers: 18-0291; 1K01DE027087-01 ( U.S. NIH Grant/Contract )
• First Posted: May 1, 2018
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol
• Time Frame: 9-36 months following publication

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:

Teeth; Periodontal disease; acute inflammatory response; stent-induced biofilm overgrowth; periodontal pathogens

Additional relevant MeSH terms:

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases