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Completed

NCT Number: NCT04373356

Non-invasive Caries Management: Clinical Study

Clinical trial to compare non-invasive and minimally-invasive therapies on the progression of the caries lesions. Clinical investigation of resin infiltration versus sodium fluoride (5% NaF) varnish application.

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Key information

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schulich School of Medicine & Dentistry - Western University

London, Ontario, N6A 3K7, Canada

About this study

Dental caries is the most globally prevalent disease that affects thousands of adults and children. Caries is a biofilm-mediated, sugar-driven, multifactorial, and dynamic disease that results from the imbalance between demineralization and remineralization of the dental hard tissues. Preventing the onset of the disease should be the primary goal; however, once the disease is present efforts should be made by both patient and clinician to successfully reestablish the mineralization balance by the use of preventive and/or minimally-invasive methods when possible. The sodium fluoride (5% NaF) varnish is one of the most common therapies used as a non-invasive approach for caries prevention and remineralization; and, the resin infiltration materials are indicated for the minimal intervention of non-cavitated occlusal and proximal caries. The minimal intervention has been considered the new concept of caries management. Although several studies discussing minimal intervention or non-intervention are available, there is a lack of published randomized controlled trials (RCTs) providing data about the use of non-invasive therapies on incipient lesions, and its correlation with the patient's caries risk. The aim of this study is to evaluate the efficacy non-invasive and minimally-invasive therapies on the progression of the caries lesions considering the patient's caries risk.

This study will be conducted in the province of Ontario, Canada. A total of thirty patients (15 to 50 years old), who present with a minimum of two incipient proximal carious lesions on the proximal surfaces of posterior teeth (non-cavitated lesions identified as small, faint radiolucent areas seen on the intra-oral radiographs) will be asked to participate in this study. The radiologic assessment of incipient lesions will be performed by a dental radiologist, blinded to the selected treatment groups, by comparison of the radiographs imaging over time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must present at least two non-cavitated proximal caries lesions
  • Patients must be able to give informed consent in English
  • Patients must be resident in London, Ontario, or nearby locales with community fluoridation

Exclusion criteria

  • Patients presenting proximal caries that are beyond the outer third of dentin
  • Patients suffering from a disability that impairs dental hygiene performance
  • Patients that are unable to perform her/his own oral hygiene

Treatment and study plan

Resin infiltration

Device

Patients will be instructed about enhancing their oral hygiene, and will be asked to brush their teeth twice a day with fluoride toothpaste, and use dental floss daily. In short, teeth will be isolated with a rubber dam and ICON will be applied following the manufacturer's instructions. After that, the rubber dam will be removed and 5% NaF Varnish will be applied.

Standardized digital bitewing radiograph will be taken at baseline and one year after treatment for caries lesion progression comparison.

Sodium Fluoride Varnish

Device

Patients will be instructed about enhancing their oral hygiene, and will be asked to brush their teeth twice a day with fluoride toothpaste, and use dental floss daily. In short, teeth will be isolated with cotton roll and 5% NaF varnish will be applied following the manufacturer's instructions.

Standardized digital bitewing radiograph will be taken at baseline and one year after treatment for caries lesion progression comparison.

Primary outcomes

  1. Caries lesion progression

    Time frame: One year follow up

    Evaluate caries lesion progression after using DMG Icon-infiltrative resin and/or 5% NaF Varnish by comparison of baseline and one year post-treatment radiographics.

Secondary outcomes

  1. Caries risk assessment

    Time frame: One year follow up

    Evaluate non-invasive and minimally-invasive therapies on the progression of the caries lesions correlated with the patient's caries risk.

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

Non-invasive and Minimal Intervention in Dental Caries Management: Randomized Clinical Study

Acronym: NICM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 4, 2020
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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