An interventional study of Customized acrylic mouthguard in Severe Periodontitis and Acute Inflammatory Response, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Basic science
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.
1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.
This study's enrollment of 69 is above the median of 45 across 1,206 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.
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Exclusion Criteria:
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
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
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline (Day 0), Visit 5 (Day 21)
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.
Time frame: 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.
Time frame: Baseline (Day 0), Visit 5 (Day 21)
| Milestone | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Started | 36 | 33 |
| Completed | 31 | 23 |
| Not completed | 5 | 10 |
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.
| fold change | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels | 0.37 ± 1.56 | 0.65 ± 3.29 |
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.
| fold change | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Change in Interferon Gamma Inducible Protein 16 (IFI16) mRNA Expression Levels | 0.07 ± 0.53 | 0.10 ± 0.61 |
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).
| percent positive cells | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Change in the Percentage of AIM2 Positive Cells | -0.71 ± 29.77 | 4.55 ± 38.78 |
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).
| percent positive cells | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Change in Percentage of Interferon Gamma Inducible Protein 16 (IFI16) Positive Cells | 0.91 ± 27.81 | 5.46 ± 58.63 |
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.
| correlation coefficient | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Prevotellaceae | -0.1 (-0.47 to 0.29) | — |
| Bulleidia | -0.1 (-0.4 to 0.2) | — |
| Pseudoramibacter | -0.2 (-0.58 to 0.15) | — |
| Haemophilus | 0.28 (-0.1 to 0.6) | — |
| Gracilibacteria | 0.3 (-0.05 to 0.6) | — |
| Alloprevotella | -0.16 (-0.52 to 0.24) | — |
| Colibacter | 0.01 (-0.37 to 0.4) | — |
| Saccharibacteria | -0.04 (-0.4 to 0.3) | — |
| Erysipelotrichaceae | -0.01 (-0.4 to 0.3) | — |
| Mollicutes | — | 0.05 (-0.4 to 0.5) |
| Scardovia | — | -0.01 (-0.4 to 0.4) |
| Peptostreptococcaceae | — | -0.09 (-0.5 to 0.3) |
| Stomatobaculum | — | -0.2 (-0.6 to 0.2) |
| Cryptobacterium | — | -0.17 (-0.5 to 0.2) |
| Lautropia | — | 0.2 (0.2 to 0.6) |
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.
| correlation coefficient | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) |
|---|---|---|
| Prevotellaceae | -0.3 (-0.6 to 0.06) | — |
| Bulleidia | -0.3 (-0.6 to 0.05) | — |
| Pseudoramibacter | -0.36 (-0.5 to 0.2) | — |
| Haemophilus | 0.4 (-0.008 to 0.6) | — |
| Gracilibacteria | 0.2 (-0.2 to 0.5) | — |
| Alloprevotella | -0.2 (-0.5 to 0.1) | — |
| Colibacter | -0.1 (-0.5 to 0.2) | — |
| Saccharibacteria | -0.01 (-0.4 to 0.3) | — |
| Erysipelotrichaceae | -0.14 (-0.5 to 0.2) | — |
| Mollicutes | — | -0.3 (-0.6 to 0.1) |
| Scardovia | — | -0.18 (-0.5 to 0.2) |
| Peptostreptococcaceae | — | -0.02 (-0.4 to 0.4) |
| Stomatobaculum | — | -0.3 (-0.6 to 0.1) |
| Cryptobacterium | — | -0.25 (-0.6 to 0.2) |
| Lautropia | — | 0.29 (-1.7 to 0.6) |
Collected over From the time of informed consent through study completion, up to 56 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Periodontal Profile Class (PPC-A/PPC-B) | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Periodontal Profile Class (PPC-G/PPC-E) | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) | Total |
|---|---|---|---|
| Mean | 32.0 ± 12.5 | 42.3 ± 10.6 | 36.9 ± 12.8 |
| Sex: Female, Male(Participants) | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) | Total |
|---|---|---|---|
| Female | 23 | 14 | 37 |
| Male | 13 | 19 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 23 | 26 |
| Not Hispanic or Latino | 33 | 10 | 43 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 4 | 2 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 4 | 4 | 8 |
| White | 25 | 12 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 14 | 16 |
| Region of Enrollment(Participants) | Periodontal Profile Class (PPC-A/PPC-B) | Periodontal Profile Class (PPC-G/PPC-E) | Total |
|---|---|---|---|
| United States | 36 | 33 | 69 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: 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.
Ran from Oct 2018 to primary completion in Jun 2023, 56 months.
Results were first posted in Jul 2024, 1 year after primary completion.
Of 605 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 56 months is above that.
Counting every sponsor, half of 624 studies reached it within 15 months; a quarter within 7 and three quarters within 28.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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