Trial Outcomes & Findings for IFI16 is a Periodontitis Modulating Protein (NCT NCT03513497)
NCT ID: NCT03513497
Last Updated: 2024-07-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Baseline (Day 0), Visit 5 (Day 21)
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
33
|
|
Overall Study
COMPLETED
|
31
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IFI16 is a Periodontitis Modulating Protein
Baseline characteristics by cohort
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=36 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=33 Participants
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.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Visit 5 (Day 21)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.
Outcome measures
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=31 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=23 Participants
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.
|
|---|---|---|
|
Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels
|
0.37 fold change
Standard Deviation 1.56
|
0.65 fold change
Standard Deviation 3.29
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Visit 5 (Day 21)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.
Outcome measures
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=31 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=23 Participants
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.
|
|---|---|---|
|
Change in Interferon Gamma Inducible Protein 16 (IFI16) mRNA Expression Levels
|
0.07 fold change
Standard Deviation 0.53
|
0.10 fold change
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Visit 5 (Day 21)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).
Outcome measures
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=31 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=23 Participants
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.
|
|---|---|---|
|
Change in the Percentage of AIM2 Positive Cells
|
-0.71 percent positive cells
Standard Deviation 29.77
|
4.55 percent positive cells
Standard Deviation 38.78
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Visit 5 (Day 21)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).
Outcome measures
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=31 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=23 Participants
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.
|
|---|---|---|
|
Change in Percentage of Interferon Gamma Inducible Protein 16 (IFI16) Positive Cells
|
0.91 percent positive cells
Standard Deviation 27.81
|
5.46 percent positive cells
Standard Deviation 58.63
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Visit 5 (Day 21)Population: Pathogens that were not present in significance were not evaluated within a group of participants.
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.
Outcome measures
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=31 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=23 Participants
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.
|
|---|---|---|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Prevotellaceae
|
-0.1 correlation coefficient
Interval -0.47 to 0.29
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Bulleidia
|
-0.1 correlation coefficient
Interval -0.4 to 0.2
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Pseudoramibacter
|
-0.2 correlation coefficient
Interval -0.58 to 0.15
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Haemophilus
|
0.28 correlation coefficient
Interval -0.1 to 0.6
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Gracilibacteria
|
0.3 correlation coefficient
Interval -0.05 to 0.6
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Alloprevotella
|
-0.16 correlation coefficient
Interval -0.52 to 0.24
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Colibacter
|
0.01 correlation coefficient
Interval -0.37 to 0.4
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Saccharibacteria
|
-0.04 correlation coefficient
Interval -0.4 to 0.3
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Erysipelotrichaceae
|
-0.01 correlation coefficient
Interval -0.4 to 0.3
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Mollicutes
|
—
|
0.05 correlation coefficient
Interval -0.4 to 0.5
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Scardovia
|
—
|
-0.01 correlation coefficient
Interval -0.4 to 0.4
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Peptostreptococcaceae
|
—
|
-0.09 correlation coefficient
Interval -0.5 to 0.3
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Stomatobaculum
|
—
|
-0.2 correlation coefficient
Interval -0.6 to 0.2
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Cryptobacterium
|
—
|
-0.17 correlation coefficient
Interval -0.5 to 0.2
|
|
Correlation of Changes in Periodontal Pathogens With Changes of AIM2
Lautropia
|
—
|
0.2 correlation coefficient
Interval 0.2 to 0.6
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Visit 5 (Day 21)Population: Pathogens that were not present in significance were not evaluated within a group of participants.
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.
Outcome measures
| Measure |
Periodontal Profile Class (PPC-A/PPC-B)
n=31 Participants
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.
|
Periodontal Profile Class (PPC-G/PPC-E)
n=23 Participants
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.
|
|---|---|---|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Mollicutes
|
—
|
-0.3 correlation coefficient
Interval -0.6 to 0.1
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Scardovia
|
—
|
-0.18 correlation coefficient
Interval -0.5 to 0.2
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Peptostreptococcaceae
|
—
|
-0.02 correlation coefficient
Interval -0.4 to 0.4
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Stomatobaculum
|
—
|
-0.3 correlation coefficient
Interval -0.6 to 0.1
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Cryptobacterium
|
—
|
-0.25 correlation coefficient
Interval -0.6 to 0.2
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Lautropia
|
—
|
0.29 correlation coefficient
Interval -1.7 to 0.6
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Prevotellaceae
|
-0.3 correlation coefficient
Interval -0.6 to 0.06
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Bulleidia
|
-0.3 correlation coefficient
Interval -0.6 to 0.05
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Pseudoramibacter
|
-0.36 correlation coefficient
Interval -0.5 to 0.2
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Haemophilus
|
0.4 correlation coefficient
Interval -0.008 to 0.6
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Gracilibacteria
|
0.2 correlation coefficient
Interval -0.2 to 0.5
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Alloprevotella
|
-0.2 correlation coefficient
Interval -0.5 to 0.1
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Colibacter
|
-0.1 correlation coefficient
Interval -0.5 to 0.2
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Saccharibacteria
|
-0.01 correlation coefficient
Interval -0.4 to 0.3
|
—
|
|
Correlation of Changes in Periodontal Pathogens With Changes of IFI16
Erysipelotrichaceae
|
-0.14 correlation coefficient
Interval -0.5 to 0.2
|
—
|
Adverse Events
Periodontal Profile Class (PPC-A/PPC-B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Periodontal Profile Class (PPC-G/PPC-E)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Julie Marchesan, DDS, PhD
University of North Carolina at Chapel Hill
Phone: 919-537-3853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place