Trial Outcomes & Findings for Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment (NCT NCT03070444)
NCT ID: NCT03070444
Last Updated: 2022-08-09
Results Overview
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)
Results posted on
2022-08-09
Participant Flow
Participant milestones
| Measure |
Group A: CTC Retainer + Essix Retainer
The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
Group B: Essix Retainer + Essix Retainer
The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
39
|
35
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment
Baseline characteristics by cohort
| Measure |
Group A: CTC Retainer + Essix Retainer
n=52 Participants
The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
Group B: Essix Retainer + Essix Retainer
n=52 Participants
The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.1 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
17.1 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
17.1 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
104 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)Population: Dental casts were analysed. As data were not normal distributed, median values are reported.
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
Outcome measures
| Measure |
Group A: CTC Retainer + Essix Retainer
n=39 Participants
The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
Group B: Essix Retainer + Essix Retainer
n=35 Participants
The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
|---|---|---|
|
Changes in Tooth Position
|
0.05 millimeters
Interval -0.4 to 0.73
|
0.62 millimeters
Interval -0.08 to 1.49
|
SECONDARY outcome
Timeframe: T4 (5 years follow up)Population: Adolescent patients at debond (baseline), adults after 5 years
Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction
Outcome measures
| Measure |
Group A: CTC Retainer + Essix Retainer
n=39 Participants
The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
CTC retainer: The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
Group B: Essix Retainer + Essix Retainer
n=35 Participants
The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances.
Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Essix retainer maxilla: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Essix retainer mandible: The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impression: Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
Questionnaire: A questionnaire is completed at the follow-up visits.
|
|---|---|---|
|
Patients' Perception
|
93 score on a scale
Interval 79.0 to 98.0
|
92 score on a scale
Interval 69.0 to 96.0
|
Adverse Events
Group A: CTC Retainer + Essix Retainer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Essix Retainer + Essix Retainer
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place