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Prospective Randomized Controlled Trial for Prevention of Demineralization During Fixed Orthodontic Treatment

NCT04342858 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-04-13

No results posted yet for this study

Summary

Treatment with fixed orthodontic appliances is often associated with pain, which poses great challenges in the efficient brushing of the teeth thus making the teeth more vulnerable to plaque formation. Treatment duration with fixed orthodontic appliances usually extends to 18 months or even longer in some cases. This prolonged vulnerability to plaque formation frequently leads to demineralization of teeth. There is also an increase in the number of plaque retentive sites due to the fixed appliances, leading to a rapid change in the bacterial composition of the dental plaque, particularly in the number of acidogenic bacteria. The resulting enamel decalcification is also known as white spot lesions (WSLs), which is an early sign of demineralization of enamel. Enamel WSLs (EWSLs) can be observed even as early as four weeks from the start of fixed orthodontic treatment. The occurrence of EWSLs adjacent to the orthodontic brackets ranges from 15 to 85%.

The incidence of EWSLs development is higher in orthodontic patients as compared to the development of similar lesions in non-orthodontic patients. These EWSLs are not aesthetically pleasing and is certainly unacceptable when it develops during fixed orthodontic treatment that is usually performed in patients who often seek such treatment to improve their aesthetics. Additionally, even if the outcome of fixed orthodontic treatment is superior from well-aligned teeth, aesthetics can be greatly compromised with EWSLs. Therefore, the prevention of such lesions is an important concern for orthodontists.

Though professionally applied topical fluoride varnish helps in remineralization of EWSLs, an adequate supply of calcium and phosphate ions is essential for remineralization. Therefore, EWSLs on maxillary teeth could be prevented and remineralized by the use of advanced novel topical fluoride varnish with added calcium and phosphate-based delivery system.

Conditions

  • Demineralization, Tooth
  • Caries,Dental
  • White Spot Lesion

Interventions

DRUG

Fluoride Varnish

Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK

DRUG

Fluoride Varnish with tricalcium phosphate

Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA

OTHER

Oral health education

Standard oral hygiene instructions every 3 months

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Cynthia KY Yiu, MDS, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2021-03-30
Completion
2021-07-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342858 on ClinicalTrials.gov