Clinical trial NCT05331820: The Influence of Weekly Reminders on Enhancing Patient Compliance in Patients With Fixed Orthodontic Treatment
Official title: Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Compliance
Keywords: patient compliance
orthodontic patients
reminder
Lead sponsor: University of Sulaimani
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 26
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 .


Eligibility criteria: 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.

Primary outcomes:
measure: oral hygiene examination The plaque index system
timeFrame: during the intervention ( follow up for 6 months )
measure: oral hygiene examination - Bleeding Index
timeFrame: during the intervention ( follow up for 6 months )
measure: oral hygiene examination white spot lesion
timeFrame: during the intervention ( follow up for 6 months )
measure: appliance care
timeFrame: during the intervention ( follow up for 6 months )
measure: adherence to appointment
timeFrame: during the intervention ( follow up for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sulaymaniyah
country: Iraq
facility: University of Sulaimani
state: Kurdistan Region
Study officials:
affiliation: University of Sulaimani
name: Hadi M Ismail, as.professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lima 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.