Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000890437
Ethics application status
Approved
Date submitted
29/03/2025
Date registered
15/08/2025
Date last updated
15/08/2025
Date data sharing statement initially provided
15/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bracket failure rate with and without primer in orthodontic treatment
Scientific title
Orthodontic bracket failure rate in patients bonded with and without primer: a randomized controlled trial
Secondary ID [1] 314082 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malocclusion 337428 0
Condition category
Condition code
Oral and Gastrointestinal 333804 333804 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331020 0
Treatment: Other
Comparator / control treatment
In the control group, metal orthodontic brackets will be bonded using a standard protocol that includes the application of primer as part of the bonding process. The following steps will be followed:

Enamel Etching:
The buccal enamel surface of each tooth will be etched using 37% orthophosphoric acid for 30 seconds.

Rinsing:
The etched surface will be thoroughly rinsed with water for 30 seconds to remove all acid residue.

Drying:
The enamel surface will be dried using an air syringe until a frosty white appearance is observed, indicating proper etching.

Primer Application:
A thin layer of primer (e.g., Transbond XT Primer) will be applied using a brush onto the dried enamel surface. This serves as a dentine bonding agent. The primer will be air-thinned and then light-cured for 10 seconds using an LED curing light.

Adhesive Application:
Light-cured composite adhesive (e.g., Transbond XT adhesive) will be applied to the base of each metal bracket.

Bracket Placement:
The bracket will be positioned accurately at the facial axis (FA) point of each tooth.

Seating and Flash Removal:
Firm pressure will be applied to seat the bracket, and excess adhesive (flash) will be removed carefully from the margins.

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.
Control group
Active

Outcomes
Primary outcome [1] 341396 0
Detachment of bracket from the tooth/teeth also called bracket failure
Timepoint [1] 341396 0
Timepoint: Baseline, 4, 8 and 12 weeks (primary timepoint) post-randomisation
Secondary outcome [1] 445382 0
Nil
Timepoint [1] 445382 0
Nil

Eligibility
Key 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)
Minimum age
13 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
group assignments were sealed in opaque envelopes and revealed only at the time of intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft Excel 2010, generating random numbers in an adjacent column using the function (=RAND), and sorting them in ascending order.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
This study utilized a randomized split-mouth design. In each participant, the oral cavity was divided into two halves (right and left quadrants). A total of 100% of the metal orthodontic brackets were bonded, with 50% of the brackets (on one randomly assigned side of the mouth) bonded using a primer, and the remaining 50% (on the contralateral side) bonded without the use of primer.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/08/2024
Date of last participant enrolment
Anticipated
Actual
3/11/2024
Date of last data collection
Anticipated
Actual
3/02/2025
Sample size
Target
42
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 26919 0
Pakistan
State/province [1] 26919 0

Funding & Sponsors
Funding source category [1] 318939 0
Self funded/Unfunded
Name [1] 318939 0
This study is genuinely unfunded. No external financial support, staff time, resources, or facilities (including in-kind support) were provided by any organization or individual.
Country [1] 318939 0
Pakistan
Primary sponsor type
University
Name
Khyber medical university
Address
Country
Pakistan
Secondary sponsor category [1] 321405 0
None
Name [1] 321405 0
Address [1] 321405 0
Country [1] 321405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317188 0
Ethical review committee of Saidu college of Dentisty, Pakistan
Ethics committee address [1] 317188 0
Ethics committee country [1] 317188 0
Pakistan
Date submitted for ethics approval [1] 317188 0
01/08/2024
Approval date [1] 317188 0
02/08/2024
Ethics approval number [1] 317188 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140290 0
Dr Umar Hussain
Address 140290 0
hyber Medical University, Institute of Dental Sciences, Block No. 1, PDA Building, Phase 5, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
Country 140290 0
Pakistan
Phone 140290 0
+92 345 4500578
Fax 140290 0
Email 140290 0
[email protected]
Contact person for public queries
Name 140291 0
Umar Hussain
Address 140291 0
hyber Medical University, Institute of Dental Sciences, Block No. 1, PDA Building, Phase 5, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
Country 140291 0
Pakistan
Phone 140291 0
+92 345 4500578
Fax 140291 0
Email 140291 0
[email protected]
Contact person for scientific queries
Name 140292 0
Umar Hussain
Address 140292 0
hyber Medical University, Institute of Dental Sciences, Block No. 1, PDA Building, Phase 5, Hayatabad, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
Country 140292 0
Pakistan
Phone 140292 0
+92 345 4500578
Fax 140292 0
Email 140292 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• On reasonable request

What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

• Data will avaialable from corresponding

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.