Description

After obtaining approval from the Ethical Review Committee and taking informed assent and informed consent from the child and parents respectively, patients fulfilling the study selection criteria will be recruited in the study as participants. Patients visiting the orthodontic clinic at the Aga Khan University Hospital Karachi will be included in this study. Detailed information regarding the study will be provided to the participants and they will be given the choice to either accept or refuse their inclusion in the study. Bulk fill composite and light cure conventional composite will be used to bond the brackets in the study participants undergoing orthodontic treatment. Bulk fill composite and light cure conventional composite will be randomly allocated to the right and left quadrants of maxillary and mandibular arches. Bracket bond failure and clinical measurements (plaque accumulation and gingival health) will be recorded at four intervals. First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3). Data will be collected on an organized study proforma.

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