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NCT Number: NCT05331820

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

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 .

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Key information

Conditions

Patient Compliance Behavior Health Behavior Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sulaimani

Sulaymaniyah, Kurdistan Region, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

weekly mobile reminder

Other

a weekly reminder will be sent to participants in the intervention group via mobile internet applications

Primary outcomes

  1. 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

  2. oral hygiene examination - Bleeding Index

    Time frame: 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

    Time frame: 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

    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

  5. 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 .

Sponsors and collaborators

Lead sponsor

Shara Qadir Hussein

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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