Non-invasive Caries Management: Clinical Study (NICM)

Western University, Canada

Status: Completed

Conditions: Caries Arrested; Caries,Dental

Treatments: Device: Resin Infiltration; Device: Sodium Fluoride Varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT04373356

115761

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Resin Infiltration

Experimental group

Description:

The interproximal surface with initial dental caries that are selected for this group will be treated using the resin infiltration ICON (DMG, Germany) and 5% Sodium Fluoride Varnish

Treatment:

Device: Resin Infiltration

Sodium Fluoride Varnish

Active Comparator group

Description:

The interproximal surface with initial dental caries that are selected for this group will be treated using topical application of 5% Sodium Fluoride Varnish.

Treatment:

Device: Sodium Fluoride Varnish