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Clinical Trials/NCT03841825
NCT03841825
Completed
Not Applicable

Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial

Virginia Commonwealth University1 site in 1 country67 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oral Hygiene
Sponsor
Virginia Commonwealth University
Enrollment
67
Locations
1
Primary Endpoint
Change in 3-item Bleeding Index (BI)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.

Detailed Description

Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of this research study is to compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Participation in this study will last up to 6 months and will consist of 4 study visits to the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to assess participant's oral health will be taken during these visits. Participants will be randomly assigned to 1 of 4 groups which may include receiving different types of text messages, repeated in-person oral hygiene instructions, or both, or neither.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
March 6, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 11-20 that have their own mobile device
  • Patients have cellular plan that allows them to receive text messages at no extra cost
  • Patients that will undergo treatment with full fixed appliances

Exclusion Criteria

  • patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
  • Pregnant women

Outcomes

Primary Outcomes

Change in 3-item Bleeding Index (BI)

Time Frame: 8 - 12 weeks to 12 - 18 weeks

Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding

Secondary Outcomes

  • Change in 5-item Modified Gingival Index (MGI)(8 - 12 weeks to 12 - 18 weeks)
  • Change in 6 item Plaque index (PI)(8 - 12 weeks to 12 - 18 weeks)

Study Sites (1)

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