Trial Outcomes & Findings for Periodontal Disease Prevention Study (NCT NCT01584479)

Results Overview

Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.

Recruitment status

COMPLETED

Target enrollment

5117 participants

Primary outcome timeframe

16 years

Results posted on

2015-07-09

Participant Flow

From 25,452 individuals meeting inclusion criteria, 9,927 (0.39 of eligible) consented to participate, and 5,117(0.515 of consented) returned completed questionnaires and were successfully genotyped.

Participant milestones

Participant milestones
Measure	Low Risk Experimental Group 1 visit - Low Risk 732 evaluable subjects \- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)	Low Risk Control Group 2 visits - Low Risk 1,668 evaluable subjects \- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)	High Risk Experimental Group 1 visit - High Risk 852 evaluable subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)	High Risk Control Group 2 visits - High Risk 1,847 evaluable subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)
Overall Study STARTED	732	1686	852	1847
Overall Study COMPLETED	732	1686	852	1847
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Periodontal Disease Prevention Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Risk Experimental Group n=732 Participants 1 visit - Low Risk \~1200 subjects \- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)	Low Risk Control Group n=1686 Participants 2 visits - Low Risk \~1200 subjects \- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)	High Risk Experimental Group n=852 Participants 1 visit - High Risk \~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)	High Risk Control Group n=1847 Participants 2 visits - High Risk \~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)	Total n=5117 Participants Total of all reporting groups
Age, Customized >34 and < 55 years	732 participants n=93 Participants	1686 participants n=4 Participants	852 participants n=27 Participants	1847 participants n=483 Participants	5117 participants n=36 Participants
Sex: Female, Male Female	461 Participants n=93 Participants	1130 Participants n=4 Participants	537 Participants n=27 Participants	1238 Participants n=483 Participants	3366 Participants n=36 Participants
Sex: Female, Male Male	271 Participants n=93 Participants	556 Participants n=4 Participants	315 Participants n=27 Participants	609 Participants n=483 Participants	1751 Participants n=36 Participants
Region of Enrollment United States	732 participants n=93 Participants	1686 participants n=4 Participants	852 participants n=27 Participants	1847 participants n=483 Participants	5117 participants n=36 Participants

PRIMARY outcome

Timeframe: 16 years

Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.

Outcome measures

Outcome measures
Measure	Low Risk Experimental Group n=732 Participants 1 visit - Low Risk \~1200 subjects \- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)	Low Risk Control Group n=1686 Participants 2 visits - Low Risk \~1200 subjects \- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)	High Risk Experimental Group n=852 Participants 1 visit - High Risk \~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)	High Risk Control Group n=1847 Participants 2 visits - High Risk \~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)
Percentage of Participants With Tooth Loss Over 16 Year Period	16.4 percentage of participants	13.8 percentage of participants	22.1 percentage of participants	16.9 percentage of participants

SECONDARY outcome

Timeframe: 10 and 15 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 and 15 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 and 15 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 and 15 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 and 15 years

Outcome measures

Outcome data not reported

Adverse Events

Low Risk Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Risk Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Risk Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

High Risk Control Group

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

William Giannobile, Principal Investigator

University of Michigan

Phone: 734-764-1562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place