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NCT07491796: 1STEP-2STEP-LC
Comparison of One-Step and Two-Step Light Curing of Bonding Agents and Composite in Orthodontics
NA trial testing One step light curing of bonding agent and composite in Orthodontic Treatment in 64 participants. Completed in 12 September 2025.
15 December 2024
Quick facts
| Lead sponsor | Shaheed Zulfiqar Ali Bhutto Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 4 May 2022 |
| Primary completion | 15 December 2024 |
| Estimated completion | 12 September 2025 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- One step light curing of bonding agent and composite
- Two step light curing of bonding agent and composite
Conditions studied
- Orthodontic Treatment — all drugs for Orthodontic Treatment →
- Bracket Failure — all drugs for Bracket Failure →
Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Who can join
12 Months and older, any sex, with Orthodontic Treatment or Bracket Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07491796
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07491796 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shaheed Zulfiqar Ali Bhutto Medical University
- Last refreshed: 24 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07491796.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing