Intense Education of Periodontal Health Maintenance

Not Applicable

Completed

• Conditions: Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus
• Interventions: Behavioral: Intense education

• Registration Number: NCT03610607
• Lead Sponsor: Meharry Medical College

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intense education of periodontal health maintenance	Intense education	-
No intense education of periodontal health maintenance	Intense education	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Meharry Medical College; 🇺🇸 Nashville, Tennessee, United States