Mobile Oral Health Intervention Effectiveness on Orthodontic Patients' Oral Hygiene and Oral Health Literacy

December 20, 2024 updated by: Nermine Balbaa, Alexandria University

Effectiveness of Mobile Oral Health Intervention on Oral Hygiene and Oral Health Literacy Among Orthodontic Patients: a Randomized Controlled Clinical Trial)

Orthodontic patients face unique challenges in maintaining optimal oral hygiene due to the presence of fixed orthodontic appliances, which tend to increase plaque retention, leading to gingival inflammation. Oral Health Literacy (OHL) plays a role in an individual's ability to understand and implement oral hygiene instructions effectively. Mobile oral health interventions involve the use of mobile technology such as smartphones to improve oral hygiene practices and outcomes.

Aim of the study: To assess the effectiveness of a mobile oral health intervention using WhatsApp messages as compared to standard oral hygiene instructions on oral hygiene status and OHL level among orthodontic patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Dentistry, Alexandria University
        • Contact:
        • Contact:
          • Nermine M Balbaa, Demonstrator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients undergoing orthodontic treatment with fixed appliances in both arches for the first time.
  2. Patients between the age of 16 and 25 years.
  3. Participants must own a smartphone with WhatsApp installed.
  4. Those who agree to be part of the research project and accept the informed consent.

Exclusion Criteria:

  1. The presence of systemic diseases affecting oral health.
  2. Patients with cleft lip and/or palate.
  3. Functional and orthognathic patients.
  4. Previous orthodontic treatment.
  5. Patients with a removable appliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile Oral Health Intervention
Mobile oral health intervention in addition to oral hygiene instructions
Behavioral: Mobile Oral Health Intervention
46 messages delivered over a 3-month period (12 weeks) via WhatsApp
No Intervention: Control
oral hygiene instructions only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Health Literacy
Time Frame: Change from baseline to 1 month, 3 months, 6 months
oral health literacy as measured by the Oral Health Literacy - Adult Questionnaire (OHL-AQ). Scores of all questions answered by participants will be added to obtain the overall score of OHL ranging from 0 to 17. Scores are categorized into three groups: Inadequate (0-9), Borderline (10-11), and Adequate (12-17) OHL level
Change from baseline to 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Hygiene
Time Frame: Change from baseline to 1 month, 3 months, 6 months
assessed by the Silness-Löe Plaque Index (PI) to provide mean PI score for each tooth ranging from 0 to 3.
Change from baseline to 1 month, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Nermine Balbaa, BDS, Teaching Assistant, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0913-05/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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