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 ID: NCT03954145

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-08
• Study Completion Date: 2021-05-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Enamel pumicing before bonding the lingual retainer.

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Enamel sandblasting before bonding the lingual retainer.

Intervention Type: 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.

Interventions

Enamel pumicing before bonding the lingual retainer.

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.

Intervention Type: PROCEDURE

Enamel sandblasting before bonding the lingual retainer.

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pôle de Médecine et Chirurgie Bucco-Dentaires

Strasbourg, Bas Rhin, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 40885597 (View on PubMed)

Other Identifiers

7434

Identifier Type: -

Identifier Source: org_study_id