Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment

NCT07155343 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2024-9142-30284
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare the survival rate (days) of orthodontic bracket bond to the tooth, and the secondary objective is to compare the dental plaque accumulation and gingival health using plaque index and gingival index respectively between brackets bonded with bulk fill composite and light cure conventional composite in patients undergoing fixed orthodontic treatment over a period of three months.

Conditions

Survival Rate of Bonded Brackets

Keywords

Bulk fill composite; Bond failure rate; Fixed orthodontic treatment

Outcome Measures

Primary Outcomes (1)

• Survival Time of Orthodontic Bracket Bond

  The number of days the bonded orthodontic brackets remain adhered to the tooth surface without failure. Bracket bond failure will be recorded at each follow-up visit, and survival time will be calculated for each bracket in both intervention groups (bulk fill composite vs conventional composite). The aim is to compare the average survival duration between the two materials over the study period.

  First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).

Secondary Outcomes (1)

• Plaque Accumulation and Gingival Health

  First, at the time of brackets bonding (T0), after one month (T1), two months (T2) and three months follwow-up (T3).

Study Arms (2)

Brackets Bonded Using Bulk Fill Composite

EXPERIMENTAL

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.

Combination Product: Bulk Fill Composite

Brackets Bonded Using Conventional Composite

ACTIVE COMPARATOR

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.

Combination Product: Conventional Composite

Interventions

Bulk Fill Composite COMBINATION_PRODUCT

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 Bulk Fill Composite

Conventional Composite COMBINATION_PRODUCT

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.

Brackets Bonded Using Conventional Composite

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rizwan Khalil: lead
• Aga Khan University Hospital, Pakistan: collaborator

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

Central Study Contacts

Rizwan Khalil, Bachelor of Dental Surgery

CONTACT

+923326078008; rizwan.khalil@aku.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Orthodontic

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: September 4, 2025
• Study Start: July 21, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)