Intense Education of Periodontal Health Maintenance

Shifting the Ratio of S. Cristatus vs. P. Gingivalis in Periodontitis Patients by Intense Education of Periodontal Health Maintenance

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.

Study Overview

• Status: Completed
• Conditions: Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus
• Intervention / Treatment: Behavioral: Intense education

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 Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37208
      • Meharry Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: MeXie2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participants data for all primary and secondary outcome measures will be made available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No