Intense Education of Periodontal Health Maintenance

Sponsor
Meharry Medical College (Other)
Overall Status
Recruiting
CT.gov ID
NCT03610607
Collaborator
The University of Texas Health Science Center, Houston (Other)
270
1
2
52
5.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intense education
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Shifting the Ratio of S. Cristatus vs. P. Gingivalis in Periodontitis Patients by Intense Education of Periodontal Health Maintenance
Actual Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: intense education of periodontal health maintenance

Behavioral: Intense education
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.

Placebo Comparator: No intense education of periodontal health maintenance

Behavioral: Intense education
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.

Outcome Measures

Primary Outcome Measures

  1. Improvement of periodontal condition [9 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meharry Medical College Nashville Tennessee United States 37208

Sponsors and Collaborators

  • Meharry Medical College
  • The University of Texas Health Science Center, Houston

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Meharry Medical College
ClinicalTrials.gov Identifier:
NCT03610607
Other Study ID Numbers:
  • MeXie2018
First Posted:
Aug 1, 2018
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 4, 2020