Trial Outcomes & Findings for Comparison of Bonding Failure Rates of Fixed Lingual Mandibular Retainers in a French Sample Aged 11 or Older, Comparing Prior Enamel Sandblasting With Conventional Pumice Polishing (NCT NCT03954145)
NCT ID: NCT03954145
Last Updated: 2026-06-29
Results Overview
Participants presenting at least one debonding event of the fixed mandibular lingual retainer during the 18-month follow-up period. A retainer was considered failed if at least one bonded tooth became detached.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
18 months after bonding of the fixed mandibular lingual retainer
Results posted on
2026-06-29
Participant Flow
Participant milestones
| Measure |
PUMICING GROUP
Lingual surfaces of the lower incisors and canines are pumiced before bonding the lingual retainer.
Teeth are being cleaned using a brush loaded with pumice and mounted on a low speed contra-angle.Teeth are then etched and the multi-braided retainer wire is being bonded with composite onto the lingual surfaces of the lower canines and incisors
|
SANDBLASTING GROUP
Enamel is being initially prepared through sandblasting the lingual surfaces of the mandibular canines and incisors.
Sandblasting is performed with the help of a MicroEtcher IIATM (Danville) which is projecting 50 μm Al2O3 particles onto the enamel surfaces. Teeth are subsequently etched and the retainer is then being bonded with composite onto the lingual surfaces of the mandibular incisors and canines.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
44
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline characteristics were assessed in all randomized participants (N=88)
Baseline characteristics by cohort
| Measure |
PUMICING GROUP
n=44 Participants
Lingual surfaces of the lower incisors and canines are pumiced before bonding the lingual retainer.
Teeth are being cleaned using a brush loaded with pumice and mounted on a low speed contra-angle.Teeth are then etched and the multi-braided retainer wire is being bonded with composite onto the lingual surfaces of the lower canines and incisors
|
SANDBLASTING GROUP
n=44 Participants
Enamel is being initially prepared through sandblasting the lingual surfaces of the mandibular canines and incisors.
Sandblasting is performed with the help of a MicroEtcher IIATM (Danville) which is projecting 50 μm Al2O3 particles onto the enamel surfaces. Teeth are subsequently etched and the retainer is then being bonded with composite onto the lingual surfaces of the mandibular incisors and canines.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16 years
n=44 Participants
|
15.5 years
n=44 Participants
|
16.0 years
n=88 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=44 Participants • Baseline characteristics were assessed in all randomized participants (N=88)
|
24 Participants
n=44 Participants • Baseline characteristics were assessed in all randomized participants (N=88)
|
52 Participants
n=88 Participants • Baseline characteristics were assessed in all randomized participants (N=88)
|
|
Sex: Female, Male
Male
|
16 Participants
n=44 Participants • Baseline characteristics were assessed in all randomized participants (N=88)
|
20 Participants
n=44 Participants • Baseline characteristics were assessed in all randomized participants (N=88)
|
36 Participants
n=88 Participants • Baseline characteristics were assessed in all randomized participants (N=88)
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 18 months after bonding of the fixed mandibular lingual retainerPopulation: Six participants in the sandblasting group were lost to follow-up and were not included in the 18-month outcome assessment.
Participants presenting at least one debonding event of the fixed mandibular lingual retainer during the 18-month follow-up period. A retainer was considered failed if at least one bonded tooth became detached.
Outcome measures
| Measure |
PUMICING GROUP
n=44 Participants
Lingual surfaces of the lower incisors and canines are pumiced before bonding the lingual retainer.
Teeth are being cleaned using a brush loaded with pumice and mounted on a low speed contra-angle.Teeth are then etched and the multi-braided retainer wire is being bonded with composite onto the lingual surfaces of the lower canines and incisors
|
SANDBLASTING GROUP
n=38 Participants
Enamel is being initially prepared through sandblasting the lingual surfaces of the mandibular canines and incisors.
Sandblasting is performed with the help of a MicroEtcher IIATM (Danville) which is projecting 50 μm Al2O3 particles onto the enamel surfaces. Teeth are subsequently etched and the retainer is then being bonded with composite onto the lingual surfaces of the mandibular incisors and canines.
|
|---|---|---|
|
Number of Participants With at Least One Bonding Failure at 18 Months
|
11 Participants
|
3 Participants
|
Adverse Events
PUMICING GROUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SANDBLASTING 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
Quentin KAMM
Hôpitaux Universitaires de Strasbourg (HUS)/ Strasbourg University Hospital
Phone: 388115415
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place