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

NCT03954145 | Completed Results

• 1 other identifier: 7434
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Detachment of Glued Mandibular Post-orthodontic Restraints

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Procedure: Enamel pumicing before bonding the lingual retainer.

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.

Procedure: Enamel sandblasting before bonding the lingual retainer.

Interventions

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.

PUMICING GROUP

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.

SANDBLASTING GROUP

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum of 11 years of age
• At completion of fixed orthodontic therapy
• Presence of all 6 mandibular canines and incisors

You may not qualify if:

• Active decay
• Presence of dental restorations
• Tooth fracture
• Periodontal disease
• Structural anomalies affecting the lingual side of the mandibular incisors and canines
• Cleft lip and palate
• Cranio-facial syndrome
• Inability to obtain the patient informed consent

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Pôle de Médecine et Chirurgie Bucco-Dentaires

Strasbourg, Bas Rhin, 67000, France

Location

Related Publications (1)

• 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.

  PMID: 40885597 RESULT

Results Point of Contact

• Title: Quentin KAMM
• Organization: Hôpitaux Universitaires de Strasbourg (HUS)/ Strasbourg University Hospital

dpidrci@chru-strasbourg.fr

388115415

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 17, 2019
• Study Start: October 8, 2019
• Primary Completion: May 20, 2021
• Study Completion: May 21, 2021
• Last Updated: June 29, 2026
• Results First Posted: June 29, 2026

Record last verified: 2026-06

Locations

FR (1)