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OpenTrials
Completed

NCT Number: NCT03954145

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

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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Key information

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pôle de Médecine et Chirurgie Bucco-Dentaires

Strasbourg, Bas Rhin, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants With at Least One Bonding Failure at 18 Months

    Time frame: 18 months after bonding of the fixed mandibular lingual retainer

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Comparison of Bonding Failure Rates of Fixed Mandibular Lingual Retainers in a French Sample Aged 11 or Older Comparing Prior Enamel Sandblasting With Conventional Pumice Polishing

Acronym: CONTORTHO

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 17, 2019
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.