Back to resultsOral Hygiene Compliance in Orthodontic Patients Using Active Reminders
Primary Purpose
Oral Hygiene, Dental Plaque
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
WhatsApp reminders
Instagram reminders
Phone calls
Application alerts
Sponsored by
About this trial
This is an interventional prevention trial for Oral Hygiene
Eligibility Criteria
Inclusion Criteria: Subjects with a complete natural dentition. Patients who need to undergo orthodontic therapy using fixed appliances. Good oral hygiene, with no signs and symptoms of periodontal disease. Patients with no medical or mental problems. Exclusion Criteria: Patients with health risks associated with periodontal probing. Syndromic patients ex; Down syndrome. Previous orthodontic treatment. Patients with carious teeth
Sites / Locations
- Faculty of Dentistry, Alexandria UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
No Intervention
Arm Label
WhatsApp messages
Instagram messages
Phone calls
App alerts
No active reminders
Arm Description
Outcomes
Primary Outcome Measures
Gingival bleeding
This will be assessed using the bleeding index (BI) upon probing the mesio-buccal, direct buccal, and disto-buccal aspects of the gingival sulci of the teeth. BI scoring ranges from 0-2; 0: no bleeding after 30 seconds, 1: bleeding after 30 seconds, 2: immediate bleeding
Gingival inflammation
This will be assessed using the modified gingival index (MGI). One MGI measurement of the buccal marginal gingiva for each tooth will be scored. Scoring ranges from 0-4 where 0 indicates absence of inflammation, 1: mild inflammation (marginal or papillary unit), 2: mild inflammation (entire marginal and papillary unit), 3: moderate inflammation, and 4: severe inflammation
Plaque accumulation
This will be assessed using the plaque index (PI). One PI measurement will be recorded for the buccal surface of each tooth. Scoring ranges from 0-5; where 0 indicates absence of plaque, 1: discontinuous plaque band at gingival margin, 2: up to 1 mm continuous plaque band at gingival margin, 3: plaque band wider than 1 mm but less than 1/3 of the surface, 4: plaque band between 1/3 and 2/3 of the surface, and 5: plaque covering 2/3 or more of the surface
Visual examination of white spot lesions
The presence of white spot lesions located on the buccal surface gingival to the archwire will be examined visually on the maxillary and mandibular six anterior teeth after being air dried for 5 seconds. Scoring ranges from 0-3; where 0: no visible white spot or surface disruption, 1: visible white spot without surface disruption, 2: visible white spot with roughened surface, 3: visible white spot requiring restoration.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06080321
Brief Title
Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders
Official Title
Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Hygiene, Dental Plaque
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WhatsApp messages
Arm Type
Experimental
Arm Title
Instagram messages
Arm Type
Experimental
Arm Title
Phone calls
Arm Type
Experimental
Arm Title
App alerts
Arm Type
Active Comparator
Arm Title
No active reminders
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
WhatsApp reminders
Intervention Description
Patients will receive active oral hygiene reminders in the form of WhatsApp messages one weekday each week. The standardized text message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Intervention Type
Other
Intervention Name(s)
Instagram reminders
Intervention Description
Patients will receive active oral hygiene reminders in the form of Instagram messages one weekday each week. The standardized text message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Intervention Type
Other
Intervention Name(s)
Phone calls
Intervention Description
Patients will receive active oral hygiene reminders in the form of phone calls one weekday each week. The structured phone call will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Intervention Type
Other
Intervention Name(s)
Application alerts
Intervention Description
Patients will download an app on their mobile phones which has cleaning tips, demonstrations and alerts. The structured message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Primary Outcome Measure Information:
Title
Gingival bleeding
Description
This will be assessed using the bleeding index (BI) upon probing the mesio-buccal, direct buccal, and disto-buccal aspects of the gingival sulci of the teeth. BI scoring ranges from 0-2; 0: no bleeding after 30 seconds, 1: bleeding after 30 seconds, 2: immediate bleeding
Time Frame
up to 6 months
Title
Gingival inflammation
Description
This will be assessed using the modified gingival index (MGI). One MGI measurement of the buccal marginal gingiva for each tooth will be scored. Scoring ranges from 0-4 where 0 indicates absence of inflammation, 1: mild inflammation (marginal or papillary unit), 2: mild inflammation (entire marginal and papillary unit), 3: moderate inflammation, and 4: severe inflammation
Time Frame
up to 6 months
Title
Plaque accumulation
Description
This will be assessed using the plaque index (PI). One PI measurement will be recorded for the buccal surface of each tooth. Scoring ranges from 0-5; where 0 indicates absence of plaque, 1: discontinuous plaque band at gingival margin, 2: up to 1 mm continuous plaque band at gingival margin, 3: plaque band wider than 1 mm but less than 1/3 of the surface, 4: plaque band between 1/3 and 2/3 of the surface, and 5: plaque covering 2/3 or more of the surface
Time Frame
up to 6 months
Title
Visual examination of white spot lesions
Description
The presence of white spot lesions located on the buccal surface gingival to the archwire will be examined visually on the maxillary and mandibular six anterior teeth after being air dried for 5 seconds. Scoring ranges from 0-3; where 0: no visible white spot or surface disruption, 1: visible white spot without surface disruption, 2: visible white spot with roughened surface, 3: visible white spot requiring restoration.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a complete natural dentition.
Patients who need to undergo orthodontic therapy using fixed appliances.
Good oral hygiene, with no signs and symptoms of periodontal disease.
Patients with no medical or mental problems.
Exclusion Criteria:
Patients with health risks associated with periodontal probing.
Syndromic patients ex; Down syndrome.
Previous orthodontic treatment.
Patients with carious teeth
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar M Adel, PhD
Phone
1099911526
Ext
+20
Email
orthosamar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samar M Adel, PhD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nikhilesh R Vaid, PhD
Organizational Affiliation
Department of Orthodontics, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eiman Marzouk, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nourhan M Aly, BDS
Phone
(03) 4868308
Email
nourhan.moustafa@alexu.edu.eg
First Name & Middle Initial & Last Name & Degree
Samar M Adel, PhD
12. IPD Sharing Statement
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Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders
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