Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders

Sponsor
Nourhan M.Aly (Other)
Overall Status
Recruiting
CT.gov ID
NCT06080321
Collaborator
(none)
100
1
5
6
16.6

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: WhatsApp reminders
  • Other: Instagram reminders
  • Other: Phone calls
  • Other: Application alerts
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Gingival bleeding [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

  2. Gingival inflammation [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

  3. Plaque accumulation [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

  4. Visual examination of white spot lesions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Alexandria University Alexandria Egypt 21512

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria
ClinicalTrials.gov Identifier:
NCT06080321
Other Study ID Numbers:
  • #9/2023
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2023