The Effect of Active Reminders on Oral Hygiene in Orthodontics

NCT03330535 | Unknown

• 1 other identifier: FRP/2018/27
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Hygiene

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Verbal oral hygiene instructions

ACTIVE COMPARATOR

Participants will receive verbal oral hygiene instructions during routine orthodontic visits.

Behavioral: Verbal oral hygiene instructions

Reminders once a week

EXPERIMENTAL

Participants will receive active reminders once a week.

Behavioral: Reminders once a week

Reminders three times a week

EXPERIMENTAL

Participants will receive active reminders three times a week.

Behavioral: Reminders three times a week

Daily reminders

EXPERIMENTAL

Participants will receive active reminders daily.

Behavioral: Daily reminders

Interventions

Reminders once a week BEHAVIORAL

Participants in this group will receive active oral hygiene reminders through text messaging once a week.

Reminders once a week

Verbal oral hygiene instructions BEHAVIORAL

Participants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.

Verbal oral hygiene instructions

Reminders three times a week BEHAVIORAL

Participants in this group will receive active oral hygiene reminders through text messaging three times a week.

Reminders three times a week

Daily reminders BEHAVIORAL

Participants in this group will receive active oral hygiene reminders through text messaging on a daily basis.

Daily reminders

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (1)

Riyadh Elm University

Riyadh, Riyadh Region, 11681, Saudi Arabia

RECRUITING

Study Officials

• Omar H Alkadhi, BDS,MS

  Riyadh Colleges of Dentistry and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar H Alkadhi, BDS,MS

CONTACT

966505154754; omar.alkadhi@riyadh.edu.sa

Ahmed A Bahamid, BDS,MS

CONTACT

+966504461888; ahmed.bahamid@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Orthodontics and Clinic Director

Model Details: Four groups of participants will be formulated. Each will will receive messages in different time interval starting from none, once a week, three times a week and daily.

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: May 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 31, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)