Malaligned TeethNCT07753512
Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment
A study testing Self-etch adhesive, One-Step Adhesive and Conventional Bonding Technique in people with Malaligned Teeth and Crowding of Teeth, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
The primary goal of this study is to compare the number of white spot lesions during fixed appliance therapy between self-etch and one-step bonding systems. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaligned Teeth, Crowding of Teeth
- What is being tested?
- Self-etch adhesive, One-Step Adhesive and Conventional Bonding Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2027to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy patients 12-30 yrs
- patients undergoing fixed appliance treatment with full mouth bonding
- presence of at least 7 accessible teeth
- no cavitated lesion at time of bond up
Who cannot join
- patients with chronic or systematic diseases
- patients with fluorosis or enamel defects
- presence of fixed prosthesis
- patients on medications which could alter salivary flow
- patients with history of salivary gland disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Foundation University College of Dentistry and Hospital
Islamabad, Federal, 44000
About this study
Official title: Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment: A Split Mouth Randomized Controlled Trial
The primary goal of this study is to compare the number of white spot lesions during fixed appliance therapy between self-etch and one-step bonding systems.
Read the detailed description
The aim of this study is to compare the number of white spot lesions that appear around bonded brackets between self-etch and one-step bonding systems using visual examination and to compare amount of demineralisation using DIAGNOdent scores.
- Conditions
- Malaligned Teeth, Crowding of Teeth
- Being tested
- Self-etch adhesive, One-Step Adhesive, Conventional Bonding Technique
- Keywords
- white spot lesions, orthodontic adhesives
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-etch adhesiveCombination product
Self-Etch adhesive used for two step bonding of bracket placement.
One-Step AdhesiveCombination product
Placement of bracket using one-step adhesive system.
Conventional Bonding TechniqueCombination product
Bonding brackets using three step conventional technique; etchant , bonding agent, composite adhesive
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1: Self-Etch Adhesive | Experimental | Self- Etch Adhesive Receives: Combination Product: Self-etch adhesive |
| Control Group | Placebo comparator | Conventional bonding technique Receives: Combination Product: Conventional Bonding Technique |
| Experimental group 2: One-Step Adhesive | Experimental | Not described Receives: Combination Product: One-Step Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of white spot lesions
Measured: From bracket placement to 6 months after placement.
Demineralisation of bonded teeth
Amount of demineralisation around brackets measured
Measured: From date of bracket placement to 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malaligned TeethStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753512
- Sponsor's protocol ID
- FUCD-Ortho-2608
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient privacy
Publications
Sampson V, Sampson A. Diagnosis and treatment options for anterior white spot lesions. Br Dent J. 2020 Sep;229(6):348-352. doi: 10.1038/s41415-020-2057-x. Epub 2020 Sep 25.
PubMed 32978577Khan AR, Fida M, Gul M. Decalcification and bond failure rate in resin modified glass ionomer cement versus conventional composite for orthodontic bonding: A systematic review & meta-analysis. Int Orthod. 2020 Mar;18(1):32-40. doi: 10.1016/j.ortho.2019.10.003. Epub 2019 Dec 24.
PubMed 31882396El Helou M, Chakar S, Nicolas E, Estephan E, Cuisinier F, Barthelemi S. Can Orthodontic Adhesive Systems Inhibit the Formation and Development of White Spot Lesions During Fixed Orthodontic Treatment? A Systematic Review. J Adhes Dent. 2024 Oct 14;26:241-252. doi: 10.3290/j.jad.b5781299.
PubMed 39397759Horan OGA, Al-Khateeb SN. Comparison of three orthodontic bonding systems in white spot lesion development: a randomized clinical trial. Angle Orthod. 2023 Sep 1;93(5):531-537. doi: 10.2319/111422-781.1.
PubMed 37017436
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment: A Split Mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07753512
- Acronym / sponsor ID
- FUCD-Ortho-2608
- Conditions
- Malaligned Teeth, Crowding of Teeth
- Keywords
- white spot lesions, orthodontic adhesives
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 7 Aug 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.
The primary goal of this study is to compare the number of white spot lesions during fixed appliance therapy between self-etch and one-step bonding systems.
Detailed description
The aim of this study is to compare the number of white spot lesions that appear around bonded brackets between self-etch and one-step bonding systems using visual examination and to compare amount of demineralisation using DIAGNOdent scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1: Self-Etch Adhesive | Experimental | Combination Product: Self-etch adhesiveSelf- Etch Adhesive |
| Control Group | Placebo comparator | Combination Product: Conventional Bonding TechniqueConventional bonding technique |
| Experimental group 2: One-Step Adhesive | Experimental | Combination Product: One-Step Adhesive |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- healthy patients 12-30 yrs
- patients undergoing fixed appliance treatment with full mouth bonding
- presence of at least 7 accessible teeth
- no cavitated lesion at time of bond up
Key exclusion criteria (5 listed)
- patients with chronic or systematic diseases
- patients with fluorosis or enamel defects
- presence of fixed prosthesis
- patients on medications which could alter salivary flow
- patients with history of salivary gland disease
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 |
|---|---|---|
| Self-etch adhesiveSelf-Etch adhesive used for two step bonding of bracket placement. | Combination product | Experimental 1: Self-Etch Adhesive |
| One-Step AdhesivePlacement of bracket using one-step adhesive system. | Combination product | Experimental group 2: One-Step Adhesive |
| Conventional Bonding TechniqueBonding brackets using three step conventional technique; etchant , bonding agent, composite adhesive | Combination product | Control Group |
Primary outcome
Number of white spot lesions
Time frame: From bracket placement to 6 months after placement.
Demineralisation of bonded teeth
Time frame: From date of bracket placement to 6 months of treatment
Amount of demineralisation around brackets measured
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Background: PubMed 32978577Sampson V, Sampson A. Diagnosis and treatment options for anterior white spot lesions. Br Dent J. 2020 Sep;229(6):348-352. doi: 10.1038/s41415-020-2057-x. Epub 2020 Sep 25.
- Background: PubMed 31882396Khan AR, Fida M, Gul M. Decalcification and bond failure rate in resin modified glass ionomer cement versus conventional composite for orthodontic bonding: A systematic review & meta-analysis. Int Orthod. 2020 Mar;18(1):32-40. doi: 10.1016/j.ortho.2019.10.003. Epub 2019 Dec 24.
- Background: PubMed 39397759El Helou M, Chakar S, Nicolas E, Estephan E, Cuisinier F, Barthelemi S. Can Orthodontic Adhesive Systems Inhibit the Formation and Development of White Spot Lesions During Fixed Orthodontic Treatment? A Systematic Review. J Adhes Dent. 2024 Oct 14;26:241-252. doi: 10.3290/j.jad.b5781299.
- Background: PubMed 37017436Horan OGA, Al-Khateeb SN. Comparison of three orthodontic bonding systems in white spot lesion development: a randomized clinical trial. Angle Orthod. 2023 Sep 1;93(5):531-537. doi: 10.2319/111422-781.1.
- Individual participant dataSharing planned: No. Patient privacy
Related trials for Malaligned Teeth
Recruiting
Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms
Malocclusion, Misaligned Teeth
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-etch adhesive, One-Step Adhesive and Conventional Bonding Technique in people with Malaligned Teeth and Crowding of Teeth, run by Foundation University Islamabad 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Aug 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emaan Ahsin (92 3065843663, emaan.ahsin@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of white spot lesions (time frame: From bracket placement to 6 months after placement.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07753512, which also lists 4 linked publications.
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 10 Aug 2026.