## Protocol Section
### Identification Module
**NCT ID:** NCT01584479

**Brief Title:** Periodontal Disease Prevention Study

**Official Title:** Periodontal Disease Prevention Study:A Retrospective Cohort Study to Assess the Effect of Genetics and Dental Preventive Care on Periodontal Disease

#### Organization Study ID Info
**ID:** HUM00037624
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-07-09

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-07-09

**Type:** ESTIMATED

**Results First Submit Date:** 2014-06-13

**Results First Submit QC Date:** 2015-06-17

#### Start Date
**Date:** 2010-12

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2012-04-25
**Type:** ESTIMATED
**Study First Submit Date:** 2012-04-12
**Study First Submit QC Date:** 2012-04-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** William Giannobile

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is one component of a program to improve the maintenance of good dental health and the prevention of disease by use of risk stratification methods to efficiently guide increased preventive services to adult dental patients who are at increased risk for the major dental diseases, caries and adult periodontitis.

The investigators will use a retrospective cohort model to analyze a large dental claims database to determine if the frequency of preventive services influenced the periodontal disease outcomes and to determine if periodontal risk assessment information can be used to stratify dental patients into "high risk" and "low risk" categories that influence the effect of preventive services on periodontitis outcomes.

Primary Objective To evaluate whether dental patients who are classified as "low risk" for periodontal disease progression, based on history of periodontitis (claims history), smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.

Secondary Objectives To evaluate whether dental patients who are classified as "high risk" for periodontal disease progression, based on a history of periodontitis, smoking, diabetes, and IL-1 genetic variations, have different primary and secondary endpoints if they had two dental cleanings per year compared to one cleaning per year.

To evaluate whether dental patients who have had one dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk." To evaluate whether dental patients who have had two dental cleaning per year have different primary and secondary endpoints if they are classified as "low risk" for periodontal disease compared to patients who are classified as "high risk."

### Conditions Module

**Conditions:**

- Periodontitis

**Keywords:**

- periodontitis

### Design Module

#### Bio Spec

**Description:** buccal swabs

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 5117

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1 visit - Low Risk

\~1200 subjects

- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)

**Label:** Low Risk Experimental Group

#### Arm Group 2

**Description:** 2 visits - Low Risk

\~1200 subjects

- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)

**Label:** Low risk Control Group

#### Arm Group 3

**Description:** 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 (+)

**Label:** High Risk Experimental Group

#### Arm Group 4

**Description:** 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 (+)

**Label:** High Risk Control Group

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Percentage of Participants With Tooth Loss Over 16 Year Period

**Time Frame:** 16 years

#### Secondary Outcomes

**Measure:** Change in Total Dental Claims During Monitoring Period

**Time Frame:** 10 and 15 years

**Measure:** Change in Total Periodontal Claims During the Monitoring Period

**Time Frame:** 10 and 15 years

**Measure:** Change in Periodontal Surgery Claims

**Time Frame:** 10 and 15 years

**Measure:** Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.

**Time Frame:** 10 and 15 years

**Measure:** Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories

**Time Frame:** 10 and 15 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.

Exclusion Criteria:

* Organ transplant recipients are excluded.

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 34 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** Study may include all participants who are 34-55 years old in 1992 (48-68 years old in 2010) and who have at least a 15-year dental claim history with Delta Dental.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** Michigan Center for Oral Health Research

**State:** Michigan

**Zip:** 48106

#### Overall Officials

**Official 1:**

**Affiliation:** University of Michigan

**Name:** William V Giannobile, DDS, DMedSc

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Giannobile WV, Braun TM, Caplis AK, Doucette-Stamm L, Duff GW, Kornman KS. Patient stratification for preventive care in dentistry. J Dent Res. 2013 Aug;92(8):694-701. doi: 10.1177/0022034513492336. Epub 2013 Jun 10.

**PMID:** 23752171

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: HIGH

- As Found: Periodontal Diseases

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000010510

- Term: Periodontal Diseases

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** This is an survey research study with the patient collection of their own biological specimen and the filling out of a survey to release their payer data (non-interventional).

#### Event Groups

**Group ID:** EG000

**Title:** Low Risk Experimental Group

**Description:** 1 visit - Low Risk

\~1200 subjects

- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)

**ID:** EG000

**Other Num at Risk:** 732

**Serious Number At Risk:** 732

**Title:** Low Risk Experimental Group

**Group ID:** EG001

**Title:** Low Risk Control Group

**Description:** 2 visits - Low Risk

\~1200 subjects

- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)

**ID:** EG001

**Other Num at Risk:** 1686

**Serious Number At Risk:** 1686

**Title:** Low Risk Control Group

**Group ID:** EG002

**Title:** High Risk Experimental Group

**Description:** 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 (+)

**ID:** EG002

**Other Num at Risk:** 852

**Serious Number At Risk:** 852

**Title:** High Risk Experimental Group

**Group ID:** EG003

**Title:** High Risk Control Group

**Description:** 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 (+)

**ID:** EG003

**Other Num at Risk:** 1847

**Serious Number At Risk:** 1847

**Title:** High Risk Control Group

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 732

**Group ID:** BG001

**Value:** 1686

**Group ID:** BG002

**Value:** 852

**Group ID:** BG003

**Value:** 1847

**Group ID:** BG004

**Value:** 5117

**Units:** Participants

### Group

**ID:** BG000

**Title:** Low Risk Experimental Group

**Description:** 1 visit - Low Risk

\~1200 subjects

- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)

### Group

**ID:** BG001

**Title:** Low Risk Control Group

**Description:** 2 visits - Low Risk

\~1200 subjects

- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)

### Group

**ID:** BG002

**Title:** High Risk Experimental Group

**Description:** 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 (+)

### Group

**ID:** BG003

**Title:** High Risk Control Group

**Description:** 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 (+)

### Group

**ID:** BG004

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 732

#### Measurement

**Group ID:** BG001

**Value:** 1686

#### Measurement

**Group ID:** BG002

**Value:** 852

#### Measurement

**Group ID:** BG003

**Value:** 1847

#### Measurement

**Group ID:** BG004

**Value:** 5117

**Class Title:** >34 and < 55 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 461

#### Measurement

**Group ID:** BG001

**Value:** 1130

#### Measurement

**Group ID:** BG002

**Value:** 537

#### Measurement

**Group ID:** BG003

**Value:** 1238

#### Measurement

**Group ID:** BG004

**Value:** 3366

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 271

#### Measurement

**Group ID:** BG001

**Value:** 556

#### Measurement

**Group ID:** BG002

**Value:** 315

#### Measurement

**Group ID:** BG003

**Value:** 609

#### Measurement

**Group ID:** BG004

**Value:** 1751

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 732

#### Measurement

**Group ID:** BG001

**Value:** 1686

#### Measurement

**Group ID:** BG002

**Value:** 852

#### Measurement

**Group ID:** BG003

**Value:** 1847

#### Measurement

**Group ID:** BG004

**Value:** 5117

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** The participants analyzed had to be within this age range during the year 2010.
**Parameter Type:** NUMBER
**Title:** Age, Customized
**Unit of Measure:** participants
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
**Population Description:** See Giannobile et al 2013 manuscript included
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** wgiannob@umich.edu
**Organization:** University of Michigan
**Phone:** 734-764-1562
**Title:** William Giannobile, Principal Investigator
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22.1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.9
**Title:** 
#### Outcome Measure 2
#### Outcome Measure 3
#### Outcome Measure 4
#### Outcome Measure 5
#### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 16 years
**Title:** Percentage of Participants With Tooth Loss Over 16 Year Period
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** 1 visit - Low Risk

\~1200 subjects

- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)
**ID:** OG000
**Title:** Low Risk Experimental Group
##### Group
**Description:** 2 visits - Low Risk

\~1200 subjects

- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)
**ID:** OG001
**Title:** Low Risk Control Group
##### Group
**Description:** 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 (+)
**ID:** OG002
**Title:** High Risk Experimental Group
##### Group
**Description:** 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 (+)
**ID:** OG003
**Title:** High Risk Control Group
#### Outcome Measure 2
**Reporting Status:** NOT_POSTED
**Time Frame:** 10 and 15 years
**Title:** Change in Total Dental Claims During Monitoring Period
**Type:** SECONDARY
#### Outcome Measure 3
**Reporting Status:** NOT_POSTED
**Time Frame:** 10 and 15 years
**Title:** Change in Total Periodontal Claims During the Monitoring Period
**Type:** SECONDARY
#### Outcome Measure 4
**Reporting Status:** NOT_POSTED
**Time Frame:** 10 and 15 years
**Title:** Change in Periodontal Surgery Claims
**Type:** SECONDARY
#### Outcome Measure 5
**Reporting Status:** NOT_POSTED
**Time Frame:** 10 and 15 years
**Title:** Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.
**Type:** SECONDARY
#### Outcome Measure 6
**Reporting Status:** NOT_POSTED
**Time Frame:** 10 and 15 years
**Title:** Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories
**Type:** SECONDARY
### Participant Flow Module
#### Group
**Description:** 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 (-)
**ID:** FG000
**Title:** Low Risk Experimental Group
#### Group
**Description:** 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 (-)
**ID:** FG001
**Title:** Low Risk Control Group
#### Group
**Description:** 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 (+)
**ID:** FG002
**Title:** High Risk Experimental Group
#### Group
**Description:** 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 (+)
**ID:** FG003
**Title:** High Risk Control Group
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 732
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1686
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 852
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 1847
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 732
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 1686
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 852
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 1847
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
**Recruitment Details:** 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.
**Has Results:** True