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Bracket failure rate with and without primer in orthodontic treatment

Orthodontic bracket failure rate in patients bonded with and without primer: a randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000890437
Enrollment
42
Registered
2025-08-15
Start date
2024-08-02
Completion date
2024-11-03
Last updated
2025-09-08

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 study aims to compare the failure rate of orthodontic brackets when applied with or without a primer. Orthodontic brackets are crucial for braces treatment, and a primer is often used to help the brackets bond more securely to the teeth. We want to find out if using a primer reduces the chances of brackets detaching during treatment. Our hypothesis is that the use of a primer will result in fewer bracket failures compared to when no primer is used.

Interventions

In the intervention group, metal orthodontic brackets will be bonded using a standard protocol but NO application of primer as part of the bonding process. The following steps will be followed: 1. Enamel Etching: The buccal enamel surface of each tooth will be etched using 37% orthophosphoric acid for 30 seconds. 2. Rinsing: The etched surface will be thoroughly rinsed with water for 30 seconds to remove all acid residue. 3. Drying: The enamel surface will be dried using an air syringe until a f

In the intervention group, metal orthodontic brackets will be bonded using a standard protocol but NO application of primer as part of the bonding process. The following steps will be followed: 1. Enamel Etching: The buccal enamel surface of each tooth will be etched using 37% orthophosphoric acid for 30 seconds. 2. Rinsing: The etched surface will be thoroughly rinsed with water for 30 seconds to remove all acid residue. 3. Drying: The enamel surface will be dried using an air syringe until a frosty white appearance is observed, indicating proper etching. 4. Adhesive Application: Light-cured composite adhesive (e.g., Transbond XT adhesive) will be applied to the base of each metal bracket. 5. Bracket Placement: The bracket will be positioned accurately at the facial axis (FA) point of each tooth. 6. Seating and Flash Removal: Firm pressure will be applied to seat the bracket, and excess adhesive (flash) will be removed carefully from the margins. 7. Final Curing: The bonded bracket will be light-cured for 20 seconds using an LED curing light, typically 10 seconds from mesial and 10 seconds from distal sides.

Sponsors

Khyber medical university
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
13 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

• Aged between 12 and 30 years. • Both genders • Patient starting orthodontic treatment with upper and lower fixed appliances (pre-adjusted edgewise) • Have any malocclusion (Angle class I, II, and III) • Pakistani nationals (assessed on the basis of NIC)

Exclusion criteria

• Patients having dental anomalies such as enamel hypoplasia, fluorosis • Teeth with caries or restorations on facial enamel surface • Teeth with occlusal interferences • Poor oral hygiene

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026