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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Hygiene, White Spot Lesion, Gingivitis

Intervention / Treatment
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* Behavioral: Oral hygiene instructions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No messages or oral hygiene instructions | |
| Experimental: Text message reminders<br>Standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays | Behavioral: Oral hygiene instructions<br>* Oral hygiene instructions and motivation<br>|
| Active Comparator: In-person oral hygiene instructions<br>Oral hygiene instructions and motivation during visit | Behavioral: Oral hygiene instructions<br>* Oral hygiene instructions and motivation<br>|
| Experimental: Text messages and in-person instructions<br>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<br>* Oral hygiene instructions and motivation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Initial visit to 4 - 6 weeks | 
| 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 | 4 - 6 weeks to 8 - 12 weeks | 
| 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 | 8 - 12 weeks to 12 - 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Initial visit to 4 - 6 weeks | 
| 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 | 4 - 6 weeks to 8 - 12 weeks | 
| 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 | 8 - 12 weeks to 12 - 18 weeks | 
| 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 | Initial visit to 4 - 6 weeks | 
| 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 | 4 - 6 weeks to 8 - 12 weeks | 
| 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 | 8 - 12 weeks to 12 - 18 weeks |