Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment: A Split Mouth Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self-etch adhesive, One-Step Adhesive, Conventional Bonding Technique.
- Who it may be relevant to
- Registry conditions: Malaligned Teeth, Crowding of Teeth. Basic parameters: 12 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Combination product Self-etch adhesive
Self-Etch adhesive used for two step bonding of bracket placement. - Combination product One-Step Adhesive
Placement of bracket using one-step adhesive system. - Combination product Conventional Bonding Technique
Bonding brackets using three step conventional technique; etchant , bonding agent, composite adhesive
Primary outcome measures
- 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]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- Foundation University College of Dentistry and Hospital — Islamabad
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. PMID 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. PMID 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. PMID 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. PMID 37017436
Identifiers
NCT: NCT07753512 · FUCD-Ortho-2608