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A clinical study on the preventive effects of fluoride in orthodontic populations with different caries risk.

A randomized controlled clinical study of the effect of fluoride varnish and fluoride foam on the prevention and treatment of white spots in orthodontically susceptible people with caries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083541
Enrollment
Unknown
Registered
2024-04-26
Start date
2022-10-12
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesions

Interventions

Low caries-susceptible control group:No fluoride use, oral hygiene promotion only
Low-caries-susceptible fluorinated foam group:Apply fluorinated foam every six months
Highly caries-susceptible fluorinated varnish group b:Apply fluorinated varnish every six months
Low caries-susceptible fluorinated varnish group:Apply fluorinated varnish every six months
High caries-susceptible foam group a:Apply fluorinated foam every three months
Highly caries-susceptible fluorinated varnish group a:Apply fluorinated varnish every three months
High caries-susceptible foam group b:Apply fluorinated foam every six months

Sponsors

Hospital of Stomatology Xi‘an jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 40, healthy, with no history of systemic diseases; 2. Using fixed MBT straight wire orthodontic technique, with a treatment period of at least 12 months; 3. All participants’ upper and lower front teeth and premolars are well-developed, have normal color, no enamel hypoplasia, no hereditary mottled teeth, neither parents nor participants have lived in high-fluoride areas, and no tetracycline-stained teeth; 4. Fully communicate with the participants and their families before treatment to ensure they voluntarily take part in the study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. There are cavities in the teeth that haven't been properly treated; 2. Poor compliance, unable to come for follow-ups on time; 3. Has a smoking habit; 4. Has a history of allergies to fluoride-containing products; 5. Patients with bronchial asthma.

Design outcomes

Primary

MeasureTime frame
EDI;

Secondary

MeasureTime frame
the prevalence of enamel demineralization;

Countries

China

Contacts

Public ContactLi Xiang

Hospital of Stomatology Xi‘an jiaotong University

3381635383@qq.com+86 15619037513

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 27, 2026