Bulk-fill versus conventional composite for bonding orthodontic brackets
Official title: Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment - A Split-mouth Randomized Controlled Trial
Run by Aga Khan University Hospital, Pakistan · NCT07155343 · Data updated 2026-11-12
This will test whether bonding braces with a bulk-fill composite or a conventional light-cure composite lasts longer and affects plaque or gum health in people aged 13–40 getting fixed orthodontic treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 13 Years to 40 Years |
| Sex | All |
| Enrollment | 53 (estimated) |
| Sponsor | Aga Khan University Hospital, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | July 21, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 4, 2025 |
| Trial ID | NCT07155343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 13–40 starting fixed orthodontic treatment who have good oral hygiene (plaque and gingival indices grade 1 or below) and can provide informed consent/assent.
✕Probably not a fit
Patients with enamel defects, existing periodontal disease, systemic illnesses (like diabetes or hypertension), pregnancy or nursing, craniofacial syndromes, or prior orthodontic treatment are excluded and may not benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients receiving fixed orthodontic treatment at Aga Khan University Hospital Karachi will have brackets bonded with bulk-fill composite on one side of the mouth and conventional light-cure composite on the other, allocated at random to right or left quadrants. The primary outcome is bracket survival time (days) and secondary outcomes are plaque accumulation and gingival health measured by plaque index and gingival index. Measurements are taken at bonding (T0) and at one, two, and three months follow-up (T1–T3). An interim analysis will be performed to monitor safety and look for early signs of effectiveness or futility.
Why it matters
Potential benefit: If successful, this could reduce how often brackets come off and help maintain better plaque and gum health during the first three months of braces.
How similar studies have gone: Previous adhesive and bonding studies have shown mixed results, and using bulk-fill composite specifically for bracket bonding is less commonly tested than conventional composites.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Patients aged between 13 - 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
Where it's running
-
Aga Khan University Hospital
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Study coordinator: Rizwan Khalil, Bachelor of Dental Surgery
- Email: rizwan.khalil@aku.edu
- Phone: +923326078008
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Sweet almonds to help heal femur and tibia shaft fractures
This test will see if eating sweet almonds helps adults aged 18–55 with trauma-related femur or tibia shaft fractures heal their bones faster and safely.
-
Direct versus indirect fixed retainer placement: bonding time, gum health, and retainer stability
This trial will test whether direct or indirect fixed retainer placement is quicker and leads to better gum health and fewer retainer failures for adults (18–40) finishing orthodontic treatment.
-
Verbal versus brochure information for people having uroflowmetry
This trial will test whether giving adults a printed brochure instead of only verbal instructions reduces anxiety and improves satisfaction during uroflowmetry.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.