Patient Compliance Clinical Trial
Official title:
Influence of Reminder on Enhancing Patient Compliance in Patients With Fixed Orthodontic Appliance Treatment (a Randomized Controlled Clinical Trial)
NCT number | NCT05331820 |
Other study ID # | 1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 28, 2021 |
Est. completion date | April 1, 2023 |
Verified date | April 2023 |
Source | University of Sulaimani |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Completed |
Enrollment | 26 |
Est. completion date | April 1, 2023 |
Est. primary completion date | March 13, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 30 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Iraq | University of Sulaimani | Sulaymaniyah | Kurdistan Region |
Lead Sponsor | Collaborator |
---|---|
Shara Qadir Hussein |
Iraq,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 ) | |
Primary | oral hygiene examination - Bleeding Index | 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 |
during the intervention ( follow up for 6 months ) | |
Primary | 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 ) | |
Primary | 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 ) | |
Primary | 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 |
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