RecruitingEarly Phase 1NCT07155343

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

Comparison of the Brackets Bonded With Bulk Fill Composite and Conventional Composite in Patients Undergoing Fixed Orthodontic Treatment - A Split-mouth Randomized Controlled Trial

Sponsor

Rizwan Khalil

Enrollment

53 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Survival Rate of Bonded Brackets

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.

Eligibility

Min Age: 13 YearsMax Age: 40 Years

Inclusion Criteria4

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 Criteria6

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

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Interventions

COMBINATION_PRODUCTBulk 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.

COMBINATION_PRODUCTConventional 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.

Locations(1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan

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NCT07155343