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

Sponsor
Shara Qadir Hussein (Other)
Overall Status
Recruiting
CT.gov ID
NCT05331820
Collaborator
(none)
40
1
2
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Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
  • Other: weekly mobile reminder
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)
Actual Study Start Date :
Nov 28, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. oral hygiene examination The plaque index system [during the intervention ( follow up for 6 months )]

    consists of 4 degree higher score is the worst situation and 0 is the best

  2. oral hygiene examination - Bleeding Index [during the intervention ( follow up for 6 months )]

    bleeding on probing . conatains 3 scores 0 - no bleeding bleeding after 30 seconds bleeding immediately score 0 is the best and score 2 is the worst

  3. oral hygiene examination white spot lesion [during the intervention ( follow up for 6 months )]

    white spot lesion on the tooth will be examined clinically and recorded in photographs

  4. appliance care [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

  5. adherence to appointment [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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Sulaimani Sulaymaniyah Kurdistan Region Iraq

Sponsors and Collaborators

  • Shara Qadir Hussein

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shara Qadir Hussein, investigator, University of Sulaimani
ClinicalTrials.gov Identifier:
NCT05331820
Other Study ID Numbers:
  • 1
First Posted:
Apr 18, 2022
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shara Qadir Hussein, investigator, University of Sulaimani

Study Results

No Results Posted as of Apr 18, 2022