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At the completion of orthodontic treatment, the position of the mandibular canines and incisors is being maintained on a routine basis by bonding a multi-braided wire retainer onto their lingual surfaces. One of the adverse events that might occur with time is the debonding of the wire from one or several lower anterior teeth . This event which can unfortunately get unnoticed by the patient can lead to unwanted tooth displacement. When the practionner detects such a debonding, he has to go through a laborious and lengthy procedure to rebond the wire. When on the other hand the patient notices himself such a debonding, he is to call in emergency his practitioner to get his retainer repaired. This leads to emergency visits that are susceptible to affect adversely his timetable. The prevalence of these bonding failures is estimated at 37% at 18 month follow-ups. It has been reported that with prior enamel sandblasting, bonding failure rate is reduced to 8% at 24 month follow-ups. However, no study has reported yet the debonding rate of lower fixed, comparing wires that have been bonded after prior enamel pumicing to those that were put in place after prior enamel sandblasting.
The expected result of this trial is a significantly decrease in bonding failure rate of mandibular lingual retainer when enamel surfaces are initially sandblasted compared to the ones which are pumiced. This reduction would lower the risk of unwanted tooth movement of mandibular incisors and canines after orthodontic treatment and decrease the number of emergency appointments for the patient and the practitioner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUMICING GROUP | Active Comparator | 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 |
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| SANDBLASTING GROUP | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enamel pumicing before bonding the lingual retainer. | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Bonding Failure at 18 Months | 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. | 18 months after bonding of the fixed mandibular lingual retainer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pôle de Médecine et Chirurgie Bucco-Dentaires | Strasbourg | Bas Rhin | 67000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40885597 | Result | Kamm Q, Phonchareun E, Esquenet M, Rafflenbeul F, Severac F, Bolender Y. Comparison of bonding failure rates of mandibular retainers after 2 enamel preparations - sandblasting vs pumicing: An 18-month randomized controlled trial. Am J Orthod Dentofacial Orthop. 2025 Sep;168(3):262-272. doi: 10.1016/j.ajodo.2025.04.015. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2019 |
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| Enamel sandblasting before bonding the lingual retainer. | Procedure | 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. |
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| FG001 |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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The difference of 6 patients is due to patients who were lost to follow-up and did not attend their appointments.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Inter-Quartile Range | years |
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| Sex: Female, Male | Baseline characteristics were assessed in all randomized participants (N=88) | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With at Least One Bonding Failure at 18 Months | 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. | Six participants in the sandblasting group were lost to follow-up and were not included in the 18-month outcome assessment. | Posted | Count of Participants | Participants | 18 months after bonding of the fixed mandibular lingual retainer |
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Death, serious adverse events and other (non serious adverse events) were not assessed for the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quentin KAMM | Hôpitaux Universitaires de Strasbourg (HUS)/ Strasbourg University Hospital | 388115415 | +33 | dpidrci@chru-strasbourg.fr |
| Jun 3, 2026 |
| Prot_SAP_000.pdf |
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