Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT03841825
Collaborator
(none)
67
1
4
13.1
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Oral hygiene instructions
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial
Actual Study Start Date :
Feb 1, 2019
Actual Primary Completion Date :
Mar 6, 2020
Actual Study Completion Date :
Mar 6, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

No messages or oral hygiene instructions

Experimental: Text message reminders

Standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays

Behavioral: Oral hygiene instructions
Oral hygiene instructions and motivation

Active Comparator: In-person oral hygiene instructions

Oral hygiene instructions and motivation during visit

Behavioral: Oral hygiene instructions
Oral hygiene instructions and motivation

Experimental: Text messages and in-person instructions

standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays and oral hygiene instructions and motivation during visit

Behavioral: Oral hygiene instructions
Oral hygiene instructions and motivation

Outcome Measures

Primary Outcome Measures

  1. Change in 3-item Bleeding Index (BI) [Initial visit to 4 - 6 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

  2. Change in 3-item Bleeding Index (BI) [4 - 6 weeks to 8 - 12 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

  3. Change in 3-item Bleeding Index (BI) [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 Outcome Measures

  1. Change in 5-item Modified Gingival Index (MGI) [Initial visit to 4 - 6 weeks]

    Dental examiner observation of inflammation during exam after wires have been removed and participant has brushed teeth. Ratings are 0=Absence of inflammation, 1=Mild inflammation (marginal or papillary unit), 2=Mild inflammation (entire marginal and papillary unit), 3=Moderate inflammation, 4=severe inflammation

  2. Change in 5-item Modified Gingival Index (MGI) [4 - 6 weeks to 8 - 12 weeks]

    Dental examiner observation of inflammation during exam after wires have been removed and participant has brushed teeth. Ratings are 0=Absence of inflammation, 1=Mild inflammation (marginal or papillary unit), 2=Mild inflammation (entire marginal and papillary unit), 3=Moderate inflammation, 4=severe inflammation

  3. Change in 5-item Modified Gingival Index (MGI) [8 - 12 weeks to 12 - 18 weeks]

    Dental examiner observation of inflammation during exam after wires have been removed and participant has brushed teeth. Ratings are 0=Absence of inflammation, 1=Mild inflammation (marginal or papillary unit), 2=Mild inflammation (entire marginal and papillary unit), 3=Moderate inflammation, 4=severe inflammation

  4. Change in 6 item Plaque index (PI) [Initial visit to 4 - 6 weeks]

    Dental examiner observation of plaque during exam after wires have been removed and participant has brushed teeth. Ratings are 0= no plaque, 1=Discontinuous band of plaque at gingival margin, 2=Up to 1-mm continuous band of plaque at gingival margin, 3=Band of plaque wider than 1 mm but less than 1/3 of surface, 4=Plaque covering between 1/3 and 2/3 of surface, 5=Plaque covering 2/3 or more of surface

  5. Change in 6 item Plaque index (PI) [4 - 6 weeks to 8 - 12 weeks]

    Dental examiner observation of plaque during exam after wires have been removed and participant has brushed teeth. Ratings are 0= no plaque, 1=Discontinuous band of plaque at gingival margin, 2=Up to 1-mm continuous band of plaque at gingival margin, 3=Band of plaque wider than 1 mm but less than 1/3 of surface, 4=Plaque covering between 1/3 and 2/3 of surface, 5=Plaque covering 2/3 or more of surface

  6. Change in 6 item Plaque index (PI) [8 - 12 weeks to 12 - 18 weeks]

    Dental examiner observation of plaque during exam after wires have been removed and participant has brushed teeth. Ratings are 0= no plaque, 1=Discontinuous band of plaque at gingival margin, 2=Up to 1-mm continuous band of plaque at gingival margin, 3=Band of plaque wider than 1 mm but less than 1/3 of surface, 4=Plaque covering between 1/3 and 2/3 of surface, 5=Plaque covering 2/3 or more of surface

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age 11-20 that have their own mobile device

  2. Patients have cellular plan that allows them to receive text messages at no extra cost

  3. Patients that will undergo treatment with full fixed appliances

Exclusion Criteria:
  1. patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis

  2. Pregnant women

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

  • Principal Investigator: Shroff Bhavna, DDS, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT03841825
Other Study ID Numbers:
  • HM20014910
First Posted:
Feb 15, 2019
Last Update Posted:
Sep 10, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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 10, 2020