Trial Outcomes & Findings for Comparison of Modified Vacuum-formed Retainers Versus Hawley Retainer (NCT NCT04237298)
NCT ID: NCT04237298
Last Updated: 2025-01-03
Results Overview
Mean changes across 24-month study period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
24-month post-debond
Results posted on
2025-01-03
Participant Flow
Date of recruitment : 1 Aug 2019 til 31st Aug 221
Excluded: not meeting inclusion criteria, declined to participate
Participant milestones
| Measure |
Hawley Retainer
Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
Hawley retainer: Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
|
Modified Vacuum-formed Retainer Covering the Palate
The modified vacuum-formed retainer is designed to cover the palate. It is cheaper, easier to fabricate and more esthetic. Patients will be instructed to wear the retainer 24 hours during the study period.
Modified vacuum-formed retainer covering the palete: The modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Hawley Retainer
Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
Hawley retainer: Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
|
Modified Vacuum-formed Retainer Covering the Palate
The modified vacuum-formed retainer is designed to cover the palate. It is cheaper, easier to fabricate and more esthetic. Patients will be instructed to wear the retainer 24 hours during the study period.
Modified vacuum-formed retainer covering the palete: The modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hawley Retainer
n=17 Participants
Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
Hawley retainer: Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
|
Modified Vacuum-formed Retainer Covering the Palate
n=18 Participants
The modified vacuum-formed retainer is designed to cover the palate. It is cheaper, easier to fabricate and more esthetic. Patients will be instructed to wear the retainer 24 hours during the study period.
Modified vacuum-formed retainer covering the palete: The modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.88 years
STANDARD_DEVIATION 4.12 • n=17 Participants
|
22.06 years
STANDARD_DEVIATION 5.88 • n=18 Participants
|
21.97 years
STANDARD_DEVIATION 5.03 • n=35 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=17 Participants
|
11 Participants
n=18 Participants
|
23 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=17 Participants
|
7 Participants
n=18 Participants
|
12 Participants
n=35 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 24-month post-debondPopulation: arch width (transverse)
Mean changes across 24-month study period.
Outcome measures
| Measure |
Hawley Retainer
n=17 Participants
Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
Hawley retainer: Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
|
Modified Vacuum-formed Retainer Covering the Palate
n=18 Participants
The modified vacuum-formed retainer is designed to cover the palate. It is cheaper, easier to fabricate and more esthetic. Patients will be instructed to wear the retainer 24 hours during the study period.
Modified vacuum-formed retainer covering the palete: The modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician.
|
|---|---|---|
|
Arch Width
interpremolar width
|
44.61 milimeters
Interval 43.39 to 45.82
|
46.31 milimeters
Interval 45.09 to 47.52
|
|
Arch Width
intercanine width
|
36.9 milimeters
Interval 35.76 to 38.04
|
37.65 milimeters
Interval 36.54 to 38.76
|
|
Arch Width
interfirst molar width 1
|
50.74 milimeters
Interval 49.64 to 51.85
|
52.86 milimeters
Interval 51.82 to 53.9
|
|
Arch Width
interfirst molar width 2
|
52.04 milimeters
Interval 50.78 to 53.31
|
54.05 milimeters
Interval 52.86 to 55.25
|
Adverse Events
Hawley Retainer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Modified Vacuum-formed Retainer Covering the Palate
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
Dr Asma Ashari, Orthodontist and Senior Lecturer, Principal Investigator
NUMalaysia
Phone: +60192228440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place