The Effect of Active Reminders on Oral Hygiene in Orthodontics

NCT ID: NCT03330535

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Hygiene

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Verbal oral hygiene instructions

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

Group Type ACTIVE_COMPARATOR

Verbal oral hygiene instructions

Intervention Type BEHAVIORAL

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

Reminders once a week

Participants will receive active reminders once a week.

Group Type EXPERIMENTAL

Reminders once a week

Intervention Type BEHAVIORAL

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

Reminders three times a week

Participants will receive active reminders three times a week.

Group Type EXPERIMENTAL

Reminders three times a week

Intervention Type BEHAVIORAL

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

Daily reminders

Participants will receive active reminders daily.

Group Type EXPERIMENTAL

Daily reminders

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reminders once a week

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

Intervention Type BEHAVIORAL

Verbal oral hygiene instructions

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

Intervention Type BEHAVIORAL

Reminders three times a week

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

Intervention Type BEHAVIORAL

Daily reminders

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riyadh Colleges of Dentistry and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omar Alkadhi

Lecturer in Orthodontics and Clinic Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Omar H Alkadhi, BDS,MS

Role: PRINCIPAL_INVESTIGATOR

Riyadh Colleges of Dentistry and Pharmacy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Riyadh Elm University

Riyadh, Riyadh Region, Saudi Arabia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omar H Alkadhi, BDS,MS

Role: CONTACT

Phone: 966505154754

Email: [email protected]

Ahmed A Bahamid, BDS,MS

Role: CONTACT

Phone: +966504461888

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Omar AlKadhi

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FRP/2018/27

Identifier Type: -

Identifier Source: org_study_id