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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DE027087-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0), Visit 5 (Day 21) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie T Marchesan, DDS, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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.
9-36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Periodontal Profile Class (PPC-A/PPC-B) | Periodontally healthy participants (PPC-A) and mild disease (PPC-B) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. |
| FG001 | Periodontal Profile Class (PPC-G/PPC-E) | Participants with severe periodontal disease (PPC-G) and posterior disease (PPC-E) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Periodontal Profile Class (PPC-A/PPC-B) | Periodontally healthy participants (PPC-A) and mild disease (PPC-B) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | fold change | Baseline (Day 0), Visit 5 (Day 21) |
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From the time of informed consent through study completion, up to 56 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Periodontal Profile Class (PPC-A/PPC-B) | Periodontally healthy participants (PPC-A) and mild disease (PPC-B) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Marchesan, DDS, PhD | University of North Carolina at Chapel Hill | 919-537-3853 | julie_marchesan@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2022 | Apr 10, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2022 | Jul 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 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. | Baseline (Day 0), Visit 5 (Day 21) |
| BG001 | Periodontal Profile Class (PPC-G/PPC-E) | Participants with severe periodontal disease (PPC-G) and posterior disease (PPC-E) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Periodontal Profile Class (PPC-G/PPC-E) | Participants with severe periodontal disease (PPC-G) and posterior disease (PPC-E) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | fold change | Baseline (Day 0), Visit 5 (Day 21) |
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| Primary | 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). | Posted | Mean | Standard Deviation | percent positive cells | Baseline (Day 0), Visit 5 (Day 21) |
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| Primary | 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). | Posted | Mean | Standard Deviation | percent positive cells | Baseline (Day 0), Visit 5 (Day 21) |
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| Secondary | 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. | Pathogens that were not present in significance were not evaluated within a group of participants. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline (Day 0), Visit 5 (Day 21) |
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| Secondary | 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. | Pathogens that were not present in significance were not evaluated within a group of participants. | Posted | Number | 95% Confidence Interval | correlation coefficient | Baseline (Day 0), Visit 5 (Day 21) |
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|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Periodontal Profile Class (PPC-G/PPC-E) | Participants with severe periodontal disease (PPC-G) and posterior disease (PPC-E) will wear customized acrylic mouthguard only during tooth brushing for 21 days. 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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| Bulleidia |
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| Pseudoramibacter |
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| Haemophilus |
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| Gracilibacteria |
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| Alloprevotella |
|
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| Colibacter |
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| Saccharibacteria |
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| Erysipelotrichaceae |
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| Mollicutes |
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| Scardovia |
|
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| Peptostreptococcaceae |
|
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| Stomatobaculum |
|
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| Cryptobacterium |
|
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| Lautropia |
|
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| Bulleidia |
|
|
| Pseudoramibacter |
|
|
| Haemophilus |
|
|
| Gracilibacteria |
|
|
| Alloprevotella |
|
|
| Colibacter |
|
|
| Saccharibacteria |
|
|
| Erysipelotrichaceae |
|
|
| Mollicutes |
|
|
| Scardovia |
|
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| Peptostreptococcaceae |
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| Stomatobaculum |
|
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| Cryptobacterium |
|
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| Lautropia |
|
|