Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients
Primary Purpose
Oral Hygiene, White Spot Lesion, Gingivitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral hygiene instructions
Sponsored by
About this trial
This is an interventional prevention trial for Oral Hygiene
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Active Comparator
Experimental
Arm Label
Control
Text message reminders
In-person oral hygiene instructions
Text messages and in-person instructions
Arm Description
No messages or oral hygiene instructions
Standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays
Oral hygiene instructions and motivation during visit
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
Outcomes
Primary Outcome Measures
Change in 3-item Bleeding Index (BI)
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
Change in 3-item Bleeding Index (BI)
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
Change in 3-item Bleeding Index (BI)
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
Change in 5-item Modified Gingival Index (MGI)
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
Change in 5-item Modified Gingival Index (MGI)
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
Change in 5-item Modified Gingival Index (MGI)
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
Change in 6 item Plaque index (PI)
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
Change in 6 item Plaque index (PI)
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
Change in 6 item Plaque index (PI)
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
Full Information
NCT ID
NCT03841825
First Posted
February 12, 2019
Last Updated
September 8, 2020
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03841825
Brief Title
Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients
Official Title
Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Hygiene, White Spot Lesion, Gingivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No messages or oral hygiene instructions
Arm Title
Text message reminders
Arm Type
Experimental
Arm Description
Standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays
Arm Title
In-person oral hygiene instructions
Arm Type
Active Comparator
Arm Description
Oral hygiene instructions and motivation during visit
Arm Title
Text messages and in-person instructions
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Oral hygiene instructions
Intervention Description
Oral hygiene instructions and motivation
Primary Outcome Measure Information:
Title
Change in 3-item Bleeding Index (BI)
Description
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
Time Frame
Initial visit to 4 - 6 weeks
Title
Change in 3-item Bleeding Index (BI)
Description
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
Time Frame
4 - 6 weeks to 8 - 12 weeks
Title
Change in 3-item Bleeding Index (BI)
Description
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
Time Frame
8 - 12 weeks to 12 - 18 weeks
Secondary Outcome Measure Information:
Title
Change in 5-item Modified Gingival Index (MGI)
Description
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
Time Frame
Initial visit to 4 - 6 weeks
Title
Change in 5-item Modified Gingival Index (MGI)
Description
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
Time Frame
4 - 6 weeks to 8 - 12 weeks
Title
Change in 5-item Modified Gingival Index (MGI)
Description
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
Time Frame
8 - 12 weeks to 12 - 18 weeks
Title
Change in 6 item Plaque index (PI)
Description
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
Time Frame
Initial visit to 4 - 6 weeks
Title
Change in 6 item Plaque index (PI)
Description
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
Time Frame
4 - 6 weeks to 8 - 12 weeks
Title
Change in 6 item Plaque index (PI)
Description
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
Time Frame
8 - 12 weeks to 12 - 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shroff Bhavna, DDS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients
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