The Influence of Weekly Reminders on Enhancing Patient Compliance in Patients With Fixed Orthodontic Treatment

April 16, 2023 updated by: Shara Qadir Hussein

Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)

this study is a randomized clinical trial to evaluate the effect of sending weekly reminders to patients undergoing fixed orthodontic appliance treatment. two groups will be formed and participants of the study will be divided between the two groups randomly. the intervention group will receive weekly reminders about the importance of oral hygiene and appliance care with adherence to scheduled appointments. the difference between these parameters will be evaluated between the control and intervention groups to describe the importance of weekly reminders to enhance the compliance and cooperation of the patient. the oral hygiene of the patient will include plaque level(plaque index), gingival statue level( bleeding index), and white spot lesion . appliance care will be recorded when in case of bracket failure and appointments missed will also be recorded .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Kurdistan Region
      • Sulaymaniyah, Kurdistan Region, Iraq
        • University of Sulaimani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with a fixed orthodontic appliance
  • both gender
  • age 15-25 years old
  • patient or parent have smartphone and internet connection
  • malocclusion of the patient undergoing treatment according to Index of Orthodontic Treatment Need IOTN should be grade 1,2, and 3
  • good gingival health.

Exclusion Criteria:

  • Patients with a removable appliance
  • cleft lip and palate patients
  • patients with hypomineralization visible on anterior teeth
  • susceptible to periodontal disease
  • have diabetes
  • handicap patients, a severe malocclusion above IOTN grade 3, ceramic brackets, and a child with parents that cannot read.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care group
this group of participants will be used to compare to the intervention group. normal and professional instructions and motivation will be given to them but they will not receive weekly reminders about the importance of adherence to instructions
Experimental: weekly reminder group
this group of participants will receive a weekly reminder about the importance of oral hygiene, appliance care, and adherence to recommendations from the dentist.
Other: weekly mobile reminder
a weekly reminder will be sent to participants in the intervention group via mobile internet applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oral hygiene examination The plaque index system
Time Frame: during the intervention ( follow up for 6 months )
consists of 4 degree higher score is the worst situation and 0 is the best
during the intervention ( follow up for 6 months )
oral hygiene examination - Bleeding Index
Time Frame: during the intervention ( follow up for 6 months )

bleeding on probing . conatains 3 scores 0 - no bleeding

  1. bleeding after 30 seconds
  2. bleeding immediately score 0 is the best and score 2 is the worst
during the intervention ( follow up for 6 months )
oral hygiene examination white spot lesion
Time Frame: during the intervention ( follow up for 6 months )
white spot lesion on the tooth will be examined clinically and recorded in photographs
during the intervention ( follow up for 6 months )
appliance care
Time Frame: during the intervention ( follow up for 6 months )

bracket failure will be recorded if there is any brackets/"

] bracket fracture will be recorded at appointments if there is any bracket dislodgments that needs replacement
during the intervention ( follow up for 6 months )
adherence to appointment
Time Frame: during the intervention ( follow up for 6 months
if patient does not come to the appointment it will be recorded as lack of adherence to appointments .
during the intervention ( follow up for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shara Qadir Hussein

Investigators

  • Principal Investigator: Hadi M Ismail, as.professor, University of Sulaimani

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2021

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

April 9, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The initial follow up period for this research is 6 months , if participants agree it may be increased to use in other research for longer follow up.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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