- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865625
Smartphone App Impact on Oral Hygiene in Orthodontics
The Effect of Using a Smart Phone App on Oral Hygiene and Brushing Training During Fixed Orthodontic Therapy
This study aimed to compare changes in gingival index (GI), plaque index (PI), and gingival bleeding index (GBI) values in fixed orthodontic patients. Participants were classified into two groups based on their oral hygiene: those using the Dentabuddy app for oral hygiene improvement and those receiving assistant-led toothbrushing training.
Will the use of the Dentabuddy application lead to differences in oral hygiene levels? Can adolescents effectively utilize the program? Participants will compare the effectiveness of the smartphone application with a group receiving traditional oral hygiene motivation.
Participants:
Will use the program according to the designated time intervals. Will attend their appointments regularly.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Dentabuddy application is a free oral hygiene improvement tool available for download on the Google Play Store. This study will include 60 patients aged 12-18 years who have been undergoing fixed orthodontic treatment for at least six months. Patients will be classified into good, fair, and poor oral hygiene groups based on the Simplified Oral Hygiene Index (OHI-S), assessed by the second researcher. Using the Research Randomizer website, participants will be randomly assigned to either the Dentabuddy group or the assistant-supported training group.
Gingival Index (GI), Plaque Index (PI), and Gingival Bleeding Index (GBI) values will be recorded at baseline, after one month, and after three months. These data will be compared between groups. Additionally, at the end of three months, participants will be asked to demonstrate the brushing technique they were taught using a bracketed model. Those meeting specific criteria will be classified as having successfully demonstrated the brushing technique.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Meram
-
Konya, Meram, Turkey, 42090
- Necmettin Erbakan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- no missing teeth,
- no systemic diseases or medications,
- complete permanent dentition,
- ability to maintain personal oral hygiene
Exclusion Criteria:
- dental treatment affecting oral hygiene
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dentabuddy Group with good oral hygiene
Individuals with good oral hygiene receiving oral hygiene education through the Dentabuddy application.
|
In this study, unlike similar studies in the literature, participants were grouped based on their oral hygiene status.
|
|
Dentabuddy Group with fair oral hygiene
Individuals with fair oral hygiene receiving oral hygiene education through the Dentabuddy application.
|
In this study, unlike similar studies in the literature, participants were grouped based on their oral hygiene status.
|
|
Dentabuddy Group with poor oral hygiene
Individuals with poor oral hygiene receiving oral hygiene education through the Dentabuddy application.
|
In this study, unlike similar studies in the literature, participants were grouped based on their oral hygiene status.
|
|
Assistant based trainning with good oral hygiene Group
Individuals with good oral hygiene receiving oral hygiene education through traditional methods.
|
The group demonstrating the brushing technique on a braces model
|
|
Assistant based trainning with fair oral hygiene Group
Individuals with fair oral hygiene receiving oral hygiene education through traditional methods.
|
The group demonstrating the brushing technique on a braces model
|
|
Assistant based trainning with poor oral hygiene Group
Individuals with poor oral hygiene receiving oral hygiene education through traditional methods.
|
The group demonstrating the brushing technique on a braces model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral hygiene in patients undergoing fixed orthodontic treatment
Time Frame: From August to November 2023
|
Participants whose oral hygiene scores are monitored through the use of the Dentabuddy application. The Gingival Index (GI) and Plaque Index (PI) are assessed on four surfaces of each tooth (mesial, distal, buccal/labial, and lingual) using a scale from 0 to 3. The total score from all evaluated sites is summed and divided by the total number of teeth to obtain the mean GI and PI values. A reduction in values will indicate a positive outcome of the study. |
From August to November 2023
|
Collaborators and Investigators
Investigators
- Principal Investigator: Seda Sağoğlu, Research Assistant, Konya Necmettin Erbaka University Faculty of Dentistry
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2023/319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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