Orthodontic Treatment1STEP-2STEP-LCNCT07491796
Comparison of One-Step and Two-Step Light Curing of Bonding Agents and Composite in Orthodontics
A study testing One step light curing of bonding agent and composite and Two step light curing of bonding agent and composite in people with Orthodontic Treatment and Bracket Failure, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Treatment, Bracket Failure
- What is being tested?
- One step light curing of bonding agent and composite and Two step light curing of bonding agent and composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 4 May 2022to 12 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- participants who requires orthodontic treatment with complete dentition
Who cannot join
- syndromic and cleft lip and palate patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
4th floor Orthodontics Department, School of Dentistry, Sector G-8/3 Islamabad Pakistan
Islamabad, Capital Teritory, 44000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Orthodontic Treatment, Bracket Failure
- Being tested
- One step light curing of bonding agent and composite, Two step light curing of bonding agent and composite
- Keywords
- Orthodontics, Bracket Failure, Adhesive bonding, Composite, Adhesive bonding agent, One-step bonding, Two-step bonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One step light curing of bonding agent and compositeProcedure or surgery
it is a control group which follows regular step done by orthodontists in routine bases
Two step light curing of bonding agent and compositeProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| One-Step light curing bonding agent and composite | Experimental | it's a control group Receives: 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 Receives: Procedure: Two step light curing of bonding agent and composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bracket failures (debonded brackets) during orthodontic treatment"
Number of bracket failures during orthodontic treatment Time Frame: 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start4 May 2022
- Primary completion15 Dec 2024
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- it is a randomized controlled trail.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Natasha Khalily, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Natasha Khalily, Bachelor of Dental Surgery, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491796
- Sponsor's protocol ID
- NatashaK-Thesis-RCT-Ortho-2026
- Acronym
- 1STEP-2STEP-LC
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07491796
- Acronym / sponsor ID
- 1STEP-2STEP-LC / NatashaK-Thesis-RCT-Ortho-2026
- Conditions
- Orthodontic Treatment, Bracket Failure
- Keywords
- Orthodontics, Bracket Failure, Adhesive bonding, Composite, Adhesive bonding agent, One-step bonding, Two-step bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it is a randomized controlled trail.
| Arm | Type | Receives |
|---|---|---|
| One-Step light curing bonding agent and composite | Experimental | Procedure: One step light curing of bonding agent and compositeit's a control group |
| Two-step light curing of bonding agent and composite | Experimental | Procedure: Two step light curing of bonding agent and compositeit is an experimental group contain |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- participants who requires orthodontic treatment with complete dentition
Key exclusion criteria (1 listed)
- syndromic and cleft lip and palate patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One step light curing of bonding agent and compositeit is a control group which follows regular step done by orthodontists in routine bases | Procedure or surgery | One-Step light curing bonding agent and composite |
| Two step light curing of bonding agent and compositeit 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 | Procedure or surgery | Two-step light curing of bonding agent and composite |
Primary outcome
Number of bracket failures (debonded brackets) during orthodontic treatment"
Time frame: 6 months
Number of bracket failures during orthodontic treatment Time Frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Khalily, Bachelor of Dental Surgery principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One step light curing of bonding agent and composite and Two step light curing of bonding agent and composite in people with Orthodontic Treatment and Bracket Failure, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bracket failures (debonded brackets) during orthodontic treatment" (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.