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AzTrials

White Spot Lesion of ToothNCT05764187

Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets

A study testing Orthodontic fixed appliance therapy in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
White Spot Lesion of Tooth
What is being tested?
Orthodontic fixed appliance therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteJordan
Study dates
28 Dec 2021to 1 Dec 2022
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 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm)
  • No previous orthodontic treatment
  • Optimum oral hygiene
  • Maximum of 3 restored teeth
  • Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Who cannot join

  • Subjects with poor oral hygiene
  • Defective enamel
  • Patients with syndromes and Oro-facial anomalies or salivary glands diseases

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Postgraduate Teaching Dental Clinics/JUST

    Irbid, 22110

Other trials in Jordan

About this study

Official title: Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial

The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.

Read the detailed description

Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets.

Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.

Being tested
Orthodontic fixed appliance therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orthodontic fixed appliance therapyOther

    Follow up of white spot lesion development using quantitative light induced fluorescence in patients bonded with ceramic brackets versus patients bonded with conventional metal brackets

Study groups in NCT05764187
Study groupRoleWhat they receive
Ceramic orthodontic bracketsExperimentalPatients bonded with ceramic brackets for orthodontic treatment
Receives: Other: Orthodontic fixed appliance therapy
Metal orthodontic bracketsActive comparatorPatients bonded with metal brackets for orthodontic treatment
Receives: Other: Orthodontic fixed appliance therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lesion area

    Surface area of the lesion measured in Pixels

    Measured: 4 months

  2. Mean fluorescence loss ∆F(%)

    Mean lesion fluorescence loss reflecting mineral loss measured in percent

    Measured: 4 months

  3. Maximum fluorescence loss ∆Fmax(%)

    Deepest point of the lesion

    Measured: 4 months

  4. Incidence of white spot lesions

    The number of newly developed white spot lesions

    Measured: 4 months

Secondary outcomes (1)

  1. Plaque measurement

    Amount of plaque around the orthodontic fixed appliance

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start28 Dec 2021
  3. Primary completion7 Jul 2022
  4. Study completion1 Dec 2022

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two parallel arm randomized clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764187
Sponsor's protocol ID
JUST20220107
Status last verified
Jul 2025
First submitted
4 Feb 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available upon request

Publications

  • Chalmers JM. Minimal intervention dentistry: part 1. Strategies for addressing the new caries challenge in older patients. J Can Dent Assoc. 2006 Jun;72(5):427-33.

    PubMed 16772067

  • Chapman JA, Roberts WE, Eckert GJ, Kula KS, Gonzalez-Cabezas C. Risk factors for incidence and severity of white spot lesions during treatment with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2010 Aug;138(2):188-94. doi: 10.1016/j.ajodo.2008.10.019.

    PubMed 20691360

  • Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.

    PubMed 21208070

  • Birnie D. Ceramic brackets. Br J Orthod. 1990 Feb;17(1):71-4. doi: 10.1179/bjo.17.1.71.

    PubMed 2178681

  • Russell JS. Aesthetic orthodontic brackets. J Orthod. 2005 Jun;32(2):146-63. doi: 10.1179/146531205225021024.

    PubMed 15994990

  • Fournier A, Payant L, Bouclin R. Adherence of Streptococcus mutans to orthodontic brackets. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):414-7. doi: 10.1016/s0889-5406(98)70186-6.

    PubMed 9790325

  • Rammohan SN, Juvvadi SR, Gandikota CS, Challa P, Manne R, Mathur A. Adherence of Streptococcus mutans and Candida albicans to different bracket materials. J Pharm Bioallied Sci. 2012 Aug;4(Suppl 2):S212-6. doi: 10.4103/0975-7406.100206.

    PubMed 23066254

  • Passariello C, Gigola P. Adhesion and biofilm formation by oral streptococci on different commercial brackets. Eur J Paediatr Dent. 2013 Jun;14(2):125-30.

    PubMed 23758462

  • Raju, A.S., Hegde, N.A., Reddy, V.P., Chandrashekar, B.S., Mahendra, S. and Harishkoushik, S.R. (2013) An in vivo study on bacterial colonization with metal, ceramic and self-ligating brackets: A scanning electron microscopy study. Journal of Indian Orthodontic Society, 47, 88-96.

  • al-Khateeb S, Oliveby A, de Josselin de Jong E, Angmar-Mansson B. Laser fluorescence quantification of remineralisation in situ of incipient enamel lesions: influence of fluoride supplements. Caries Res. 1997;31(2):132-40. doi: 10.1159/000262388.

    PubMed 9118185

  • Al-Khateeb S, Forsberg CM, de Josselin de Jong E, Angmar-Mansson B. A longitudinal laser fluorescence study of white spot lesions in orthodontic patients. Am J Orthod Dentofacial Orthop. 1998 Jun;113(6):595-602. doi: 10.1016/s0889-5406(98)70218-5.

    PubMed 9637561

  • van der Veen MH, de Josselin de Jong E. Application of quantitative light-induced fluorescence for assessing early caries lesions. Monogr Oral Sci. 2000;17:144-62. doi: 10.1159/000061639.

    PubMed 10949838

  • Benson PE, Parkin N, Millett DT, Dyer FE, Vine S, Shah A. Fluorides for the prevention of white spots on teeth during fixed brace treatment. Cochrane Database Syst Rev. 2004;(3):CD003809. doi: 10.1002/14651858.CD003809.pub2.

    PubMed 15266503

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PubMed 14158464

  • Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

    PubMed 5237684

Questions about this trial

What is this clinical trial studying?

A study testing Orthodontic fixed appliance therapy in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.

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 5 inclusion and 3 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 11 Jul 2025. 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 Jordan. 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?

Lesion area (time frame: 4 months). The study lists 4 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 NCT05764187, which also lists 31 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 11 Jul 2025.

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