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

Not Applicable

Completed

• Conditions: Detachment of Glued Mandibular Post-orthodontic Restraints
• Interventions: Procedure: Enamel pumicing before bonding the lingual retainer.; Procedure: Enamel sandblasting before bonding the lingual retainer.

• Registration Number: NCT03954145
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Study Start: 2019-10-08
• Primary Completion: 2021-05-20
• Study Completion: 2021-05-21
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PUMICING GROUP	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
SANDBLASTING GROUP	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.

Primary Outcome Measures

Name	Time	Method
Define the bonding failure rates of fixed mandibular lingual retainers during an 18 month follow-up, comparing prior enamel sandblasting with pumice polishing	Outcome is assessed with a probe and through visual examination at 3, 6, 9, 12, 15 and18 months after bonding the lingual retainer.

Trial Locations

Locations (1)

Pôle de Médecine et Chirurgie Bucco-Dentaires; 🇫🇷 Strasbourg, Bas Rhin, France