Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment
NCT ID: NCT07155343
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
53 participants
INTERVENTIONAL
2025-07-21
2025-12-31
Brief Summary
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Detailed Description
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Interim analysis will be run to ensure that there are no unexpected safety concerns associated with the intervention. The analysis may help determine whether the intervention is effective in achieving its desired outcomes or if there are indications of potential success. If the interim analysis will reveal overwhelming evidence of effectiveness or futility, the trial will be terminated early, saving time, money, and potential exposure to participants.
Intention to treat analysis will be applied to maintain the benefits of randomization and avoid introducing bias due to non-adherence or dropouts. By analyzing participants as part of their original assigned group, the ITT analysis provides a more conservative estimate of treatment effects, reflecting real-world scenarios where not everyone perfectly adheres to the assigned treatment.
Randomization:
Block randomization will be used to determine which side of teeth (right or left side quadrants) the bulk-fill composite will be used to bond the brackets in each participant. This will be controlled by a research faculty member of the Section of Dentistry assigned to the research by the Clinical Trials Unit AKUH.
Random Sequence Generation:
In this two-armed study, fifteen blocks each with a block size of four with any of the following six-possible allocation sequences for two treatment arms will be generated.
(1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) ABBA, (6) BAAB The blocks to be utilized and their order will be determined by the research Faculty member using sealed envelopeTM online software.
Allocation Sequence Concealment:
The treatment allocation pattern determined against each participant's ID (01-58, in ascending order) by the research faculty member, will be printed individually on paper. These papers will be sealed in an opaque envelope with the participants' ID mentioned over the envelope by a team member independent of the trial.
Enrollment:
After obtaining approval from the ERC (AKUH), each participant fulfilling the inclusion criteria for the study and consenting to participate in the trial will be assigned a participant ID.
Implementation:
During the recruitment of the participants in the trial, the sealed envelope for a participant ID will be opened to reveal the random sequence by the enrolling team member.
Blinding:
The study investigators, patients and assessors will not be blinded during the trial. The patients will be recruited by the co-principal investigator. All the measurements will be recorded by the co-investigator on the study proforma.
Inclusion Criteria:
* Patients aged between 12 - 40 years
* Patients undergoing fixed orthodontic treatment
* Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices
* All patients who will sign the informed consent/assent form
Exclusion Criteria:
* Patients with enamel surface defects
* Patients with any periodontal disease i.e. gingivitis or periodontitis
* Patients with any systemic diseases i.e. diabetes and hypertension
* Pregnant or nursing females
* Patients with craniofacial syndromes
* Subjects with a previous history of orthodontic or orthopedic treatment
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brackets Bonded Using Bulk Fill Composite
In this arm, orthodontic brackets will be bonded using a light-cured bulk fill composite resin material. The composite will be applied directly to the bracket base and cured according to the manufacturer's instructions. This group is intended to evaluate the clinical performance, bond failure rate, and handling characteristics of bulk fill composite in comparison to conventional orthodontic bonding resin. Brackets will be placed on either the right or left side of the arch, based on random allocation.
Bulk Fill Composite
Orthodontic brackets will be bonded using a bulk fill composite resin, which is formulated for faster application and reduced polymerization shrinkage compared to conventional composites. This material will be used to assess its bond strength, failure rate, and overall clinical performance.
Brackets Bonded Using Conventional Composite
In this arm, orthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin. The composite will be applied to the bracket base and cured according to the manufacturer's recommended protocol. This group will serve as the control to compare the bond strength, failure rate, and clinical performance against the bulk fill composite group. Brackets will be placed on either the right or left side of the arch, depending on the random allocation.
Conventional Composite
Orthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin that requires careful incremental application and standard curing time. This material is commonly used in routine clinical practice and serves as the benchmark for comparison.
Interventions
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Bulk Fill Composite
Orthodontic brackets will be bonded using a bulk fill composite resin, which is formulated for faster application and reduced polymerization shrinkage compared to conventional composites. This material will be used to assess its bond strength, failure rate, and overall clinical performance.
Conventional Composite
Orthodontic brackets will be bonded using a conventional light-cured orthodontic composite resin that requires careful incremental application and standard curing time. This material is commonly used in routine clinical practice and serves as the benchmark for comparison.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing fixed orthodontic treatment
* Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices
* All patients who will sign the informed consent/assent form
Exclusion Criteria
* Patients with any periodontal disease i.e. gingivitis or periodontitis
* Patients with any systemic diseases i.e. diabetes and hypertension
* Pregnant or nursing females
* Patients with craniofacial syndromes
* Subjects with a previous history of orthodontic or orthopedic treatment
13 Years
40 Years
ALL
Yes
Sponsors
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Aga Khan University Hospital, Pakistan
OTHER
Rizwan Khalil
OTHER
Responsible Party
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Rizwan Khalil
Resident Orthodontic
Locations
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Aga Khan University Hospital
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Adults informed consent form
Document Type: Informed Consent Form: Parental informed consent form
Document Type: Informed Consent Form: Adolescent informed consent form
Other Identifiers
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2024-9142-30284
Identifier Type: -
Identifier Source: org_study_id
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