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Not yet recruitingNCT07753512Updated Aug 10, 2026

Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment

An interventional study of Self-etch adhesive and One-Step Adhesive in Malaligned Teeth and Crowding of Teeth, sponsored by Foundation University Islamabad. Not yet recruiting at 1 site in Pakistan. Open to participants aged 12 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
12 Years to 30 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Malaligned Teeth
  • Crowding of Teeth

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Keywords

  • white spot lesions
  • orthodontic adhesives
03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's planned enrollment of 34 is close to the median of 36 across 74 interventional studies indexed under Crowding.

Browse Crowding studies →

Lead sponsor

Foundation University Islamabad is the lead sponsor of 255 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Experimental 1: Self-Etch Adhesive

    Self- Etch Adhesive

    Combination Product: Self-etch adhesive

  • Placebo comparator
    Control Group

    Conventional bonding technique

    Combination Product: Conventional Bonding Technique

  • Experimental
    Experimental group 2: One-Step Adhesive

    Combination Product: One-Step Adhesive

Interventions

  • Combination productSelf-etch adhesive

    Self-Etch adhesive used for two step bonding of bracket placement.

  • Combination productOne-Step Adhesive

    Placement of bracket using one-step adhesive system.

  • Combination productConventional Bonding Technique

    Bonding brackets using three step conventional technique; etchant , bonding agent, composite adhesive

06

What researchers measure

Primary outcomes

  1. Number of white spot lesions

    Time frame: From bracket placement to 6 months after placement.

  2. Demineralisation of bonded teeth

    Amount of demineralisation around brackets measured

    Time frame: From date of bracket placement to 6 months of treatment

07

Study locations

1 site
  • Foundation University College of Dentistry and Hospital
    Islamabad, Federal 44000, Pakistan
08

References and documents

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 32978577 ↗
  • Khan 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 31882396 ↗
  • El 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 39397759 ↗
  • Horan 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 ↗

Individual participant data

Plan to share: No — Patient privacy

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jan 2028, 12 months later.

Of 50 non-industry interventional studies with no phase under Crowding, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's planned 12 months is below that.

Counting every sponsor, half of 52 studies reached it within 17 months; a quarter within 11 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 4, 2026
First posted
Aug 7, 2026
StartEst.
Jan 15, 2027
Primary completionEst.
Jan 15, 2028
CompletionEst.
Jun 15, 2028
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07753512
Responsible party
Shoaib Rahim (Associate Professor, Foundation University Islamabad) — Principal investigator
First posted
Aug 7, 2026
Start date
Jan 15, 2027 (estimated)
Primary completion
Jan 15, 2028 (estimated)
Completion
Jun 15, 2028 (estimated)
Last update
Aug 10, 2026

Study contacts

Emaan Ahsin
Contact
emaan.ahsin@fui.edu.pk
92 3065843663
Rozina Nazir
Contact
rozina.nazir@fui.edu.pk
923215376612

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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