Comparison of tooth decay development around braces bonded to the tooth with two different adhesive materials.

Comparison of white spot lesion development around orthodontic brackets bonded with resin-modified glass ionomer and resin composite cements.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001639819

Enrollment

Registered

2021-11-30

Start date

2018-08-03

Completion date

2020-10-15

Last updated

2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This within-patient, split-mouth randomised controlled trial aims to determine whether orthodontic bracket bonding with resin-modified glass ionomer cement (RMGIC) to sodium hypochlorite (NaOCl) conditioned enamel will affect the development of white spot lesions (WLSs) compared to brackets bonded with resin composite cement (RC). It is hypothesised that bonding with RMGIC after pre-treatment with NaOCl will reduce the prevalence of WSLs around orthodontic brackets compared to RC.

Interventions

Bonding orthodontic brackets with resin-modified glass ionomer cement (RMGIC). This study involves assessment of the maxillary and mandibular anterior teeth only. After randomisation, two quadrants (Q1&3 or Q2&4) will have orthodontic brackets bonded with RMGIC using the following protocol: 1. Clean enamel surface with pumice 2. Condition enamel surface for 60 seconds with 5% sodium hypochlorite, followed by thorough rinsing 3. Etch enamel for 15 seconds using 37% phosphoric acid, following by thorough rinsing 4. Apply Fuji Ortho LC (GC Australasia) to the bracket and light cure according to the manufacturer’s instructions Overall duration of procedure was 5-10 minutes, and administered by either a registered orthodontist or orthodontic postgraduate student. Brackets were bonded to the teeth for a minimum of 6 months; after this, the brackets may or may not be repositioned as part of routine orthodontic treatment. There was no strategy to monitor adherence as the investigator could not be present for the bonding appointment.

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. All permanent anterior teeth present 2. All types of malocclusions 3. Treatment plan could involve orthognathic surgery or extractions 4. Consent/assent by the patient and/or parent to participate in the study

Exclusion criteria

1. Severe malposition of anterior teeth preventing brackets to be placed at the initial appointment 2. History of orthodontic treatment 3. Presence of early enamel demineralisation in the form of WSLs 4. Presence of developmental defects of enamel, such as hypomineralisation, hypoplasia or amelogenesis imperfecta

Outcome results