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Intense Education of Periodontal Health Maintenance

Primary Purpose

Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intense education
Sponsored by
Meharry Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects should have > 16 teeth, 2 or more interproximal sites with CAL >4 mm and 2 or more with pocket depth >5 mm.

Exclusion Criteria:

  • No scaling and root planing within the previous year or periodontal surgeries in the previous five years.

Sites / Locations

  • Meharry Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intense education of periodontal health maintenance

No intense education of periodontal health maintenance

Arm Description

Outcomes

Primary Outcome Measures

Improvement of periodontal condition
1. Improvement of periodontal condition Response to periodontal treatment will be determined by a composite measure including 1) Plaque Index; 2) Gingival index; 3) Cemento-enamel junction, gingival margin, probing, and bleeding on probing from six sites on all teeth. The patients will be considered to have improved, non-changed, and worsening periodontitis, according to clinical measurements and comparison them with those before treatments.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2018
Last Updated
October 20, 2023
Sponsor
Meharry Medical College
Collaborators
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03610607
Brief Title
Intense Education of Periodontal Health Maintenance
Official Title
Shifting the Ratio of S. Cristatus vs. P. Gingivalis in Periodontitis Patients by Intense Education of Periodontal Health Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meharry Medical College
Collaborators
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators hypothesize that good oral hygiene may inhibit P. gingivalis, a keystone periodontal pathogen, entering mature dental plaque, which leads to a higher ratio of S. cristatus and P. gingivalis. Investigators will educate and train periodontitis patients following periodontal therapy to maintain periodontal health. Initial and intense education of periodontal health maintenance will be provided and the ratio of S. cristatus and P. gingivalis in dental plaques will be compared and analyzed for correlation between patient's execution of periodontal health maintenance and education tools or the ratio of S. cristatus and P. gingivalis.
Detailed Description
The periodontal health maintenance will be evaluated by plaque index, periodontal pocket, and gingival inflammation status. Participants will be assigned into two groups after the second dentist visit based on their execution of periodontal health maintenance. Participants whose number of P. gingivalis is unchanged or higher compared to that found at baseline will be considered poor maintenance. Those not having maintained a good dental hygiene will further be randomly assigned to two groups. One group will be given more intense oral health education, while the other one will receive the same education as post therapy. The result of intensive education and a shift in ratio of S. cristatus and P. gingivalis will then be measured for both groups at the third dentist visit (9 months after initial periodontal treatment) and the effectiveness of the intervention will be tested at this stage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intense education of periodontal health maintenance
Arm Type
Active Comparator
Arm Title
No intense education of periodontal health maintenance
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Intense education
Intervention Description
we will inform patients with their own data including the number of P. gingivalis and ratio of S. cristatus and P. gingivalis detected immediately after periodontal treatment and 3 month after the treatment. Explaining these data in detail, in terms that the patient can understand, are equally as important as teaching the plaque control techniques.
Primary Outcome Measure Information:
Title
Improvement of periodontal condition
Description
1. Improvement of periodontal condition Response to periodontal treatment will be determined by a composite measure including 1) Plaque Index; 2) Gingival index; 3) Cemento-enamel junction, gingival margin, probing, and bleeding on probing from six sites on all teeth. The patients will be considered to have improved, non-changed, and worsening periodontitis, according to clinical measurements and comparison them with those before treatments.
Time Frame
9 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects should have > 16 teeth, 2 or more interproximal sites with CAL >4 mm and 2 or more with pocket depth >5 mm. Exclusion Criteria: No scaling and root planing within the previous year or periodontal surgeries in the previous five years.
Facility Information:
Facility Name
Meharry Medical College
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified individual participants data for all primary and secondary outcome measures will be made available.

Learn more about this trial

Intense Education of Periodontal Health Maintenance

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