- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491796
Comparison of One-Step and Two-Step Light Curing of Bonding Agents and Composite in Orthodontics (1STEP-2STEP-LC)
Effectiveness of One-Step Versus Two-Step Light Curing of Bonding Agent and Composite in Orthodontic Bracket Bonding: Study Design: A Randomized Controlled Trial. Study Type: Interventional Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Participants Undergoing Orthodontic Treatment Will be Randomly Assigned Into Two Groups. One Group Will Receive One-step Light Curing of Bonding Agent and Composite Simultaneously, While the Other Group Will Receive Two-step Curing Where the Bonding Agent is Cured First Followed by Curing of the Composite. Maskin
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.
Study Overview
Status
Conditions
Detailed Description
Think of fixing a tooth like painting a wall. You can't just slap the final colour (the paint) onto bare drywall. First, you need a coat of primer to help the paint stick. In dentistry, the paint is a tooth-coloured material called composite. The primer is a liquid called a bonding agent. This bonding agent is what makes the composite stick tightly to your tooth. To make these materials hard, the dentist uses a special bright light. This process is called light curing.
This research title is trying to find the best way to use that light. The One-Step Method: The dentist applies the bonding agent (the primer) and immediately cures it with light to harden it. Then, they put the composite on top and cure the light again to harden it.
The Two-Step Method: This means the dentist applies the bonding agent, waits for a while (a few seconds) before curing the light on it. After that's hard, they still add the composite and cure the light again.
So, the study asks: Does allowing the bonding agent to sit on the tooth for a moment before curing with light improve the adhesion and longevity of the final filling? By comparing the effectiveness of these two methods, the researchers are checking which one creates a stronger, tighter seal. A better seal means the filling is less likely to leak, break, or fall out later. In simple terms, we are figuring out the best recipe for making a filling that lasts.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Capital Teritory
-
Islamabad, Capital Teritory, Pakistan, 44000
- 4th floor Orthodontics Department, School of Dentistry, Sector G-8/3 Islamabad Pakistan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- participants who requires orthodontic treatment with complete dentition
Exclusion Criteria:
- syndromic and cleft lip and palate patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: One-Step light curing bonding agent and composite
it's a control group
|
it is a control group which follows regular step done by orthodontists in routine bases
|
|
Experimental: Two-step light curing of bonding agent and composite
it is an experimental group contain
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of bracket failures (debonded brackets) during orthodontic treatment"
Time Frame: 6 months
|
Number of bracket failures during orthodontic treatment Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Natasha Khalily, Bachelor of Dental Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NatashaK-Thesis-RCT-Ortho-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Yes, individual participant data will be shared. De-identified data, including participants' treatment details, outcomes, and measurements, will be available.
Data will be shared after publication of the main study results, for a period of 3 years.
Data will be shared upon reasonable request to researchers who provide a scientifically sound proposal and agree to use the data for research purposes only.
Requests should be directed to the Overall Study Official at natashakhalily@gmail.com
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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