The Influence of Weekly Reminders on Enhancing Patient Compliance in Patients With Fixed Orthodontic Treatment
Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)
1 other identifier
interventional
26
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 28, 2021
CompletedFirst Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
April 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 19, 2023
April 1, 2023
1.3 years
December 3, 2021
April 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
oral hygiene examination The plaque index system
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
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
white spot lesion on the tooth will be examined clinically and recorded in photographs
during the intervention ( follow up for 6 months )
appliance care
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
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
Study Arms (2)
standard care group
NO INTERVENTIONthis 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
weekly reminder group
EXPERIMENTALthis group of participants will receive a weekly reminder about the importance of oral hygiene, appliance care, and adherence to recommendations from the dentist.
Interventions
a weekly reminder will be sent to participants in the intervention group via mobile internet applications
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sulaimani
Sulaymaniyah, Kurdistan Region, Iraq
Related Publications (3)
Mohammed H, Rizk MZ, Wafaie K, Ulhaq A, Almuzian M. Reminders improve oral hygiene and adherence to appointments in orthodontic patients: a systematic review and meta-analysis. Eur J Orthod. 2019 Mar 29;41(2):204-213. doi: 10.1093/ejo/cjy045.
PMID: 29947755BACKGROUNDLima IFP, de Andrade Vieira W, de Macedo Bernardino I, Costa PA, Lima APB, Pithon MM, Paranhos LR. Influence of reminder therapy for controlling bacterial plaque in patients undergoing orthodontic treatment: A systematic review and meta-analysis. Angle Orthod. 2018 Jul;88(4):483-493. doi: 10.2319/111117-770.1. Epub 2018 Apr 17.
PMID: 29664334BACKGROUNDHussein S, Ismail H. Influence of Reminder on Enhancing Compliance in Patients with Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial). Patient Prefer Adherence. 2023 Jul 20;17:1759-1769. doi: 10.2147/PPA.S418109. eCollection 2023.
PMID: 37492635DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hadi M Ismail, as.professor
University of Sulaimani
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- the orthodontist did not know the group of their patients .
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- investigator
Study Record Dates
First Submitted
December 3, 2021
First Posted
April 18, 2022
Study Start
November 28, 2021
Primary Completion
March 13, 2023
Study Completion
April 1, 2023
Last Updated
April 19, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
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.