The Effect of Active Reminders on Oral Hygiene in Orthodontics

The Effect of Active Reminders on Oral Hygiene of Patients With Fixed Orthodontic Appliances With Different Time Intervals

The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.

Study Overview

• Status: Unknown
• Conditions: Oral Hygiene
• Intervention / Treatment: Behavioral: Verbal oral hygiene instructions; Behavioral: Reminders once a week; Behavioral: Reminders three times a week; Behavioral: Daily reminders

Detailed Description

Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar H Alkadhi, BDS,MS; Phone Number: 966505154754; Email: omar.alkadhi@riyadh.edu.sa
• Study Contact Backup: Name: Ahmed A Bahamid, BDS,MS; Phone Number: +966504461888; Email: ahmed.bahamid@riyadh.edu.sa

Study Locations

• Saudi Arabia
  • Ar Riyad
    • Riyadh, Ar Riyad, Saudi Arabia, 11681
      • Recruiting
      • Riyadh Elm University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants were having orthodontic fixed appliance treatment.
• Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
• Participants were willing to comply with given oral hygiene instructions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Verbal oral hygiene instructions; Participants will receive verbal oral hygiene instructions during routine orthodontic visits.	Behavioral: Verbal oral hygiene instructions; Participants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Experimental: Reminders once a week; Participants will receive active reminders once a week.	Behavioral: Reminders once a week; Participants in this group will receive active oral hygiene reminders through text messaging once a week.
Experimental: Reminders three times a week; Participants will receive active reminders three times a week.	Behavioral: Reminders three times a week; Participants in this group will receive active oral hygiene reminders through text messaging three times a week.
Experimental: Daily reminders; Participants will receive active reminders daily.	Behavioral: Daily reminders; Participants in this group will receive active oral hygiene reminders through text messaging on a daily basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plaque Index	Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.	At baseline, 4 weeks and 8 weeks
Change in gingival index	Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.	At baseline, 4 weeks and 8 weeks

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Omar H Alkadhi, BDS,MS, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FRP/2018/27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No