Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders

NCT06080321 | Unknown

• 1 other identifier: #9/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Hygiene; Dental Plaque

Outcome Measures

Primary Outcomes (4)

• 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

  up to 6 months

• 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

  up to 6 months

• 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

  up to 6 months

• 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.

  up to 6 months

Study Arms (5)

WhatsApp messages

EXPERIMENTAL

Other: WhatsApp reminders

Instagram messages

EXPERIMENTAL

Other: Instagram reminders

Phone calls

EXPERIMENTAL

Other: Phone calls

App alerts

ACTIVE COMPARATOR

Other: Application alerts

No active reminders

NO INTERVENTION

Interventions

WhatsApp reminders OTHER

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."

WhatsApp messages

Instagram reminders OTHER

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."

Instagram messages

Phone calls OTHER

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."

Phone calls

Application alerts OTHER

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."

App alerts

Eligibility Criteria

• Age: 11 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with health risks associated with periodontal probing.
• Syndromic patients ex; Down syndrome.
• Previous orthodontic treatment.
• Patients with carious teeth

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Samar M Adel, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Nikhilesh R Vaid, PhD

  Department of Orthodontics, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India

  STUDY CHAIR

• Eiman Marzouk, PhD

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Samar M Adel, PhD

CONTACT

1099911526; orthosamar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: October 6, 2023
• First Posted: October 12, 2023
• Study Start: October 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

EG (1)