Comparison of One-Step and Two-Step Light Curing of Bonding Agents and Composite in Orthodontics

NCT07491796 | Completed

• 1 other identifier: NatashaK-Thesis-RCT-Ortho-2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Effectiveness of One-Step Versus Two-Step Light Curing of Bonding Agent and Composite in Orthodontic Bracket Bonding: Study Design: A Randomized Controlled Trial (RCT) Study Type: Interventional Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants undergoing orthodontic treatment will be randomly assigned to two groups. One group will receive one-step (1-step) light curing of the bonding agent and composite simultaneously, and the other group will receive two-step (2-step) curing, in which the bonding agent is cured first, followed by curing of the composite. Masking: Single (Outcomes Assessor) Masking Description: The evaluator assessing outcomes, including bond failure or adhesive remnant index (ARI), will be blinded to the intervention group to minimise assessment bias. Primary Purpose: Treatment Arms and Interventions: Experimental Group Two-Step Light Curing Description: During orthodontic bracket bonding, the bonding agent and composite will be cured simultaneously using a light-curing unit according to the manufacturer's recommended curing time. Intervention Type: Procedure Intervention Name: One-Step Light Curing Technique Active Comparator Group: Two-Step Light Curing Description: During orthodontic bracket bonding, the bonding agent will be cured first, followed by curing of the composite separately using a light-curing unit according to the manufacturer's instructions. Outcome Measures Primary Outcome Measure: Bond Failure Rate of Orthodontic Brackets Description: The number of bracket failures observed during the study period will be recorded to assess the effectiveness of the curing technique. Time Frame: During the follow-up period of 6 months after bonding Secondary Outcome Measures: Adhesive Remnant Index (ARI) Score Description: ARI scores will be evaluated after bracket debonding to determine the amount of adhesive remaining on the tooth surface and to assess bonding characteristics. Time Frame: At the time of bracket debonding. Inclusion Criteria: Patients requiring fixed orthodontic treatment with Permanent dentition present, willing to participate and provide informed consent, and good oral hygiene Exclusion Criteria: Patients with enamel defects or dental fluorosis, Systemic diseases affecting oral health, and Patients with poor oral hygiene Brief Summary This randomized controlled trial aims to evaluate the effectiveness of one-step versus two-step light-curing techniques used during orthodontic bracket bonding. Adequate polymerization of the bonding agent and composite is essential to achieve optimal bond strength and reduce bracket failure. Participants requiring fixed orthodontic treatment will be randomly allocated into two groups. One group will receive simultaneous curing of the bonding agent and composite (one-step curing), and the other group will receive sequential curing of the bonding agent followed by the composite (two-step curing). The outcomes will be assessed by evaluating bond effectiveness and related clinical parameters. Successful orthodontic treatment depends greatly on the strength and durability of bracket bonding. Proper polymerization of bonding agents and composite resins is critical to ensure adequate adhesion between the bracket and tooth surface. Different light-curing techniques are used in clinical practice, including one-step curing in which both the bonding agent and composite are cured simultaneously, and two-step curing, where the bonding agent is cured first, followed by the composite. Although both techniques are commonly used, there is limited clinical evidence comparing their effectiveness during orthodontic bracket bonding. Inadequate curing may compromise bond strength and increase bracket failure rates, leading to prolonged treatment time and additional clinical procedures. This randomized controlled trial aims to compare the effectiveness of one-step and two-step light-curing techniques during orthodontic bracket bonding. Participants undergoing orthodontic treatment will be randomly assigned to one of the two intervention groups. Standardized bonding procedures will be followed to ensure consistency. The outcomes of the study will help determine whether curing both materials simultaneously or sequentially results in better clinical performance. The findings may contribute to improving bonding protocols and enhancing the efficiency and reliability of orthodontic treatment.

Conditions

Orthodontic Treatment; Bracket Failure

Keywords

Orthodontics; Bracket Failure; Adhesive bonding; Composite; Adhesive bonding agent; One-step bonding; Two-step bonding

Outcome Measures

Primary Outcomes (1)

• Number of bracket failures (debonded brackets) during orthodontic treatment"

  Number of bracket failures during orthodontic treatment Time Frame: 6 months

  6 months

Study Arms (2)

One-Step light curing bonding agent and composite

EXPERIMENTAL

it's a control group

Procedure: One step light curing of bonding agent and composite

Two-step light curing of bonding agent and composite

EXPERIMENTAL

it is an experimental group contain

Procedure: Two step light curing of bonding agent and composite

Interventions

One step light curing of bonding agent and composite PROCEDURE

it is a control group which follows regular step done by orthodontists in routine bases

One-Step light curing bonding agent and composite

Two step light curing of bonding agent and composite PROCEDURE

it is an experimental group where bonding agent is cured before application of composite. an additional step is added to the procedure which is normally not followed by orthodontists

Two-step light curing of bonding agent and composite

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• participants who requires orthodontic treatment with complete dentition

You may not qualify if:

• syndromic and cleft lip and palate patients

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

4th floor Orthodontics Department, School of Dentistry, Sector G-8/3 Islamabad Pakistan

Islamabad, Capital Teritory, 44000, Pakistan

Location

Study Officials

• Natasha Khalily, Bachelor of Dental Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Postgraduate Trainee (MDS Orthodontics)

Model Details: it is a randomized controlled trail.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 24, 2026
• Study Start: May 4, 2022
• Primary Completion: December 15, 2024
• Study Completion: September 12, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: it will be shared after publication of the main study results, for a period of 3 years
• Access Criteria: Researchers with approved proposals can get data of de-identified participant-level data (treatment outcomes, clinical measurements) will secure transfer after request and approval via email mentioned above

Locations

PA (1)