Trial Outcomes & Findings for Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention (NCT NCT03224481)

Results Overview

Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

3 months - 6 months - 12 months

Results posted on

2025-04-30

Participant Flow

Events that occurred after enrollment, but prior to assignment of participants to the treatment groups: failure to collect retainers (n= 2); mobile application did not work (n= 1); and sensor deactivated in error (n= 1).

Participant milestones

Participant milestones
Measure	Receive Electronic Reminder Participants in the intervention group will receive tailored electronic reminders. The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Electronic reminder: The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.	Control Group Participants in the control group will not receive additional reminders.
Overall Study STARTED	42	42
Overall Study COMPLETED	29	25
Overall Study NOT COMPLETED	13	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Receive Electronic Reminder n=42 Participants Participants in the intervention group will receive tailored electronic reminders. The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Electronic reminder: The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.	Control Group n=42 Participants Participants in the control group will not receive additional reminders.	Total n=84 Participants Total of all reporting groups
Age, Continuous	17.24 years STANDARD_DEVIATION 2 • n=42 Participants	17.2 years STANDARD_DEVIATION 1.89 • n=42 Participants	17.23 years STANDARD_DEVIATION 1.9 • n=84 Participants
Sex: Female, Male Female	21 Participants n=42 Participants	21 Participants n=42 Participants	42 Participants n=84 Participants
Sex: Female, Male Male	21 Participants n=42 Participants	21 Participants n=42 Participants	42 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	42 participants n=42 Participants	42 participants n=42 Participants	84 participants n=84 Participants

PRIMARY outcome

Timeframe: 3 months - 6 months - 12 months

Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer

Outcome measures

Outcome measures
Measure	Receive Electronic Reminder n=29 Participants Participants in the intervention group will receive tailored electronic reminders. The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Electronic reminder: The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.	Control Group n=25 Participants Participants in the control group will not receive additional reminders.
Wear of Removable Retainer Per Day (Hours) in the Intervention and the Control Groups	3.09 hours/day Standard Error 8.1	1.44 hours/day Standard Error 9.22

SECONDARY outcome

Timeframe: 3 months - 6 months - 12 months

Subjective levels of retainer wear as reported by participants using retainer wear chart

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months - 6 months - 12 months

Stability of teeth following orthodontic treatment measured from study models (in millimetres)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline - 3 months - 6 months

Clinical assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months - 6 months

Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Receive Electronic Reminder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Padhraig Fleming

Queen Mary University of London

Phone: 02073777397

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place