Intense Education of Periodontal Health Maintenance

NCT03610607 | Completed DMC

• 1 other identifier: MeXie2018
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

intense education of periodontal health maintenance

ACTIVE COMPARATOR

Behavioral: Intense education

No intense education of periodontal health maintenance

PLACEBO COMPARATOR

Behavioral: Intense education

Interventions

Intense education BEHAVIORAL

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.

No intense education of periodontal health maintenance; intense education of periodontal health maintenance

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 1, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

US (1)