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White Spot LesionNCT06403371

The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients

A study testing Fluoride varnsh and Normal saline in people with White Spot Lesion, run by King Abdullah University Hospital at 1 site in Jordan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Fluoride varnish is being applied on the teeth surfaces of patients undergoing orthodontic treatment just before receiving their clear aligners. The effect of the varnish was investigated if it can reduce the incidence of enamel demineralization or not. Read more about this study

Who is it for?
Ages 16 to 30 yearsHealthy volunteers can take part
Conditions the study is for
White Spot Lesion
What is being tested?
Fluoride varnsh and Normal saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteJordan
Study dates
1 Jun 2023to Oct 2024
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 16 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy subjects form both sexes
  • Mild to moderate crowding
  • Optimum oral hygiene
  • Maximum of three restored teeth

Who cannot join

  • Presence of enamel hypoplasia or hypocalcification,
  • Any salivary gland disease or medication use that affect the salivary flow
  • Subjects using fluoride other than 1450 ppm fluoride toothpaste.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Postgraduate Teaching Clinics/JUST

    Irbid, 22110

Other trials in Jordan

About this study

Official title: The Effect of Fluoride Varnish on White Spot Lesion in Clear Aligner Orthodontic Patients: Prospective Randomized Controlled Clinical Trial

Fluoride varnish is being applied on the teeth surfaces of patients undergoing orthodontic treatment just before receiving their clear aligners. The effect of the varnish was investigated if it can reduce the incidence of enamel demineralization or not.

Read the detailed description

Background: The preventive effect of fluoride varnish on the development of white spot lesions (WSLs) during clear aligner treatment has not been investigated in the literature. Hence this was the purpose of this study. Material and Methods: This was a prospective double-blinded randomized clinical trial. A total of 44 patients (7 males, 37 females, with a mean age of 20.91 ± 4.56) who sought clear aligner therapy at the postgraduate orthodontic clinics at JUST were recruited and randomly divided equally (n=22 in each group) by a website randomizer. Eligibility criteria included healthy patients of both sexes (age range 14-30 years), Class I malocclusion with mild-to-moderate crowding (≤5 mm), non-extraction treatment plan, and optimum oral hygiene before treatment. Both the patient and the investigator were blinded during the intervention and assessment of outcomes. At (T0) Fluoride varnish was applied to the subjects in Group 1, while normal saline was applied to the subjects in Group 2 as a control. Quantitative light-induced fluorescence (QLF) images were taken at the start of the treatment (T0) and after 4 months (T1). The QLF images were analyzed to assess the primary outcomes: lesion area (Pixels), the mean amount of fluorescence loss (ΔF)% in addition to the number of newly developed lesions.

Being tested
Fluoride varnsh, Normal saline
Keywords
Fluoride varnish, Clear aligners, White spot lesions, Quantitative light induced fluorescence (QLF)

What participants receive

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

  • Fluoride varnshOther

    Fluoride varnish was applied to the teeth surfaces before aligner therapy

  • Normal salineOther

    Normal saline was applied to the teeth surfaces before aligner therapy

Study groups in NCT06403371
Study groupRoleWhat they receive
Fluoride varnish groupExperimentalPatients received a layer of fluoride varnish on their teeth before the start of orthodontic clear aligner therapy
Receives: Other: Fluoride varnsh
Control groupPlacebo comparatorPatients received a layer of normal saline on their teeth before the start of orthodontic clear aligner therapy
Receives: Other: Normal saline

What is being measured

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

  1. Average lesion fluorescence loss (∆F%)

    It reflects amount of mineral loss

    Measured: 4 months

  2. Maximum lesion fluorescence loss (∆F-max%)

    It measures the deepest point of the lesion (in relation to sound enamel) using QLF system in percent

    Measured: 4 months

  3. Lesion area

    It measures white spot lesion area in pixels

    Measured: 4 months

Secondary outcomes (1)

  1. Plaque measurement

    It measures the amount of plaque on teeth surfaces in percent using QLF system

    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 posted7 May 2024
  2. Study start1 Jun 2023
  3. Primary completionJun 2024 (estimated)
  4. Study completionOct 2024 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blinded randomized controlled clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06403371
Sponsor's protocol ID
JUST20230273
Status last verified
May 2024
First submitted
16 Apr 2024
Last updated
7 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zabokova-Bilbilova E, Popovska L, Kapusevska B, Stefanovska E. White spot lesions: prevention and management during the orthodontic treatment. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2014;35(2):161-8. doi: 10.2478/prilozi-2014-0021.

    PubMed 25532098

  • Ogaard B. [Cariologic aspects of orthodontic treatment]. Nor Tannlaegeforen Tid. 1989 Dec;99(20):802-5. Norwegian.

    PubMed 2640705

  • Boersma JG, van der Veen MH, Lagerweij MD, Bokhout B, Prahl-Andersen B. Caries prevalence measured with QLF after treatment with fixed orthodontic appliances: influencing factors. Caries Res. 2005 Jan-Feb;39(1):41-7. doi: 10.1159/000081655.

    PubMed 15591733

  • Sharma S, Narkhede S, Sonawane S, Gangurde P. Evaluation of Patient's Personal Reasons and Experience with Orthodontic Treatment. J Int Oral Health. 2013 Dec;5(6):78-81. Epub 2013 Dec 26.

    PubMed 24453449

  • 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

  • Geiger AM, Gorelick L, Gwinnett AJ, Benson BJ. Reducing white spot lesions in orthodontic populations with fluoride rinsing. Am J Orthod Dentofacial Orthop. 1992 May;101(5):403-7. doi: 10.1016/0889-5406(92)70112-N.

    PubMed 1590288

  • Rossini G, Parrini S, Castroflorio T, Deregibus A, Debernardi CL. Efficacy of clear aligners in controlling orthodontic tooth movement: a systematic review. Angle Orthod. 2015 Sep;85(5):881-9. doi: 10.2319/061614-436.1. Epub 2014 Nov 20.

    PubMed 25412265

  • Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.

    PubMed 32354432

  • Todd MA, Staley RN, Kanellis MJ, Donly KJ, Wefel JS. Effect of a fluoride varnish on demineralization adjacent to orthodontic brackets. Am J Orthod Dentofacial Orthop. 1999 Aug;116(2):159-67. doi: 10.1016/s0889-5406(99)70213-1.

    PubMed 10434089

  • Banks PA, Chadwick SM, Asher-McDade C, Wright JL. Fluoride-releasing elastomerics--a prospective controlled clinical trial. Eur J Orthod. 2000 Aug;22(4):401-7. doi: 10.1093/ejo/22.4.401.

    PubMed 11029829

  • Benson PE, Douglas CW, Martin MV. Fluoridated elastomers: effect on the microbiology of plaque. Am J Orthod Dentofacial Orthop. 2004 Sep;126(3):325-30. doi: 10.1016/j.ajodo.2003.07.007.

    PubMed 15356496

  • 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

  • Gay G, Ravera S, Castroflorio T, Garino F, Rossini G, Parrini S, Cugliari G, Deregibus A. Root resorption during orthodontic treatment with Invisalign(R): a radiometric study. Prog Orthod. 2017 Dec;18(1):12. doi: 10.1186/s40510-017-0166-0. Epub 2017 May 15.

    PubMed 28503724

  • Bisht S, Khera AK, Raghav P. White spot lesions during orthodontic clear aligner therapy: A scoping review. J Orthod Sci. 2022 May 4;11:9. doi: 10.4103/jos.jos_170_21. eCollection 2022.

    PubMed 35754408

  • Sudjalim TR, Woods MG, Manton DJ. Prevention of white spot lesions in orthodontic practice: a contemporary review. Aust Dent J. 2006 Dec;51(4):284-9; quiz 347. doi: 10.1111/j.1834-7819.2006.tb00445.x.

    PubMed 17256301

Questions about this trial

What is this clinical trial studying?

A study testing Fluoride varnsh and Normal saline in people with White Spot Lesion, run by King Abdullah University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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. 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?

Results are not available in the source record.

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?

Average lesion fluorescence loss (∆F%) (time frame: 4 months). The study lists 3 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 NCT06403371, which also lists 39 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 7 May 2024.

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