IFI16 is a Periodontitis Modulating Protein

NCT03513497 | Completed Results

• 2 other identifiers: 18-02911K01DE027087-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Severe Periodontitis; Acute Inflammatory Response

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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).

  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).

  Baseline (Day 0), Visit 5 (Day 21)

Secondary Outcomes (2)

• Correlation of Changes in Periodontal Pathogens With Changes of AIM2

  Baseline (Day 0), Visit 5 (Day 21)

• Correlation of Changes in Periodontal Pathogens With Changes of IFI16

  Baseline (Day 0), Visit 5 (Day 21)

Study Arms (2)

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.

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.

Other: Customized acrylic mouthguard

Interventions

Customized acrylic mouthguard OTHER

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.

Also known as: intraoral stent

Periodontal Profile Class (PPC-A); Periodontal Profile Class (PPC-G)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Julie Marchesan, DDS, PhD
• Organization: University of North Carolina at Chapel Hill

julie_marchesan@unc.edu

919-537-3853

Study Officials

• Julie T Marchesan, DDS, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 1, 2018
• Study Start: October 18, 2018
• Primary Completion: June 28, 2023
• Study Completion: June 28, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9-36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)