NCT07753512

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jan 2027

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 15, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2028

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 4, 2026

Last Update Submit

August 6, 2026

Conditions

Malaligned TeethCrowding of Teeth

Keywords

white spot lesionsorthodontic adhesives

Outcome Measures

Primary Outcomes (2)

  • Number of white spot lesions

    From bracket placement to 6 months after placement.

  • Demineralisation of bonded teeth

    Amount of demineralisation around brackets measured

    From date of bracket placement to 6 months of treatment

Study Arms (3)

Experimental 1: Self-Etch Adhesive

EXPERIMENTAL

Self- Etch Adhesive

Combination Product: Self-etch adhesive

Control Group

PLACEBO COMPARATOR

Conventional bonding technique

Combination Product: Conventional Bonding Technique

Experimental group 2: One-Step Adhesive

EXPERIMENTAL
Combination Product: One-Step Adhesive

Interventions

Self-etch adhesiveCOMBINATION_PRODUCT

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

Experimental 1: Self-Etch Adhesive
One-Step AdhesiveCOMBINATION_PRODUCT

Placement of bracket using one-step adhesive system.

Experimental group 2: One-Step Adhesive
Conventional Bonding TechniqueCOMBINATION_PRODUCT

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

Control Group

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Dentistry and Hospital

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 32978577BACKGROUND

  • 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.

    PMID: 31882396BACKGROUND

  • 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.

    PMID: 39397759BACKGROUND

  • 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.

    PMID: 37017436BACKGROUND

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Central Study Contacts

Emaan Ahsin

CONTACT

92 3065843663emaan.ahsin@fui.edu.pk

Rozina Nazir

CONTACT

923215376612rozina.nazir@fui.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 4, 2026

First Posted

August 7, 2026

Study Start (Estimated)

January 15, 2027

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

June 15, 2028

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Patient privacy

Locations

PA(1)