Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Detachment of Glued Mandibular Post-orthodontic Restraints
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 88
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Define the bonding failure rates of fixed mandibular lingual retainers during an 18 month follow-up, comparing prior enamel sandblasting with pumice polishing
timeFrame: Outcome is assessed with a probe and through visual examination at 3, 6, 9, 12, 15 and18 months after bonding the lingual retainer.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Pôle de Médecine et Chirurgie Bucco-Dentaires
state: Bas Rhin
Study officials:
References: