Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders

October 6, 2023 updated by: Nourhan M.Aly

Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders: A Randomized Controlled Clinical Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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, 21512
        • Recruiting
        • Faculty of Dentistry, Alexandria University
        • Contact:
        • Principal Investigator:
          • Samar M Adel, PhD

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

No

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WhatsApp messages
Other: WhatsApp reminders
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."
Experimental: Instagram messages
Other: Instagram reminders
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."
Experimental: Phone calls
Other: Phone calls
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."
Active Comparator: App alerts
Other: Application alerts
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."
No Intervention: No active reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival bleeding
Time Frame: up to 6 months
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
up to 6 months
Gingival inflammation
Time Frame: up to 6 months
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
up to 6 months
Plaque accumulation
Time Frame: up to 6 months
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
up to 6 months
Visual examination of white spot lesions
Time Frame: up to 6 months
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.
up to 6 months

Collaborators and Investigators

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

Sponsor

Nourhan M.Aly

Investigators

  • Principal Investigator: Samar M Adel, PhD, Alexandria University
  • Study Chair: Nikhilesh R Vaid, PhD, Department of Orthodontics, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India
  • Study Director: Eiman Marzouk, PhD, Alexandria University

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)

October 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 6, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #9/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Oral Hygiene

Clinical Trials on WhatsApp reminders

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe