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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 (CONTORTHO)

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ClinicalTrials.gov Identifier: NCT03954145
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Detachment of Glued Mandibular Post-orthodontic Restraints Procedure: Enamel pumicing before bonding the lingual retainer. Procedure: Enamel sandblasting before bonding the lingual retainer. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Arm Intervention/treatment
Active Comparator: 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

Procedure: 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.


Experimental: 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.

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.





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


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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954145


Contacts
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Contact: Quentin Kamm, dental surgeon 00333 ext 88 11 69 5 quentin.kamm@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03954145     History of Changes
Other Study ID Numbers: 7434
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No