Non-invasive Caries Management: Clinical Study

Not Applicable

Completed

• Conditions: Caries Arrested; Caries,Dental
• Interventions: Device: Sodium Fluoride Varnish; Device: Resin Infiltration

• Registration Number: NCT04373356
• Lead Sponsor: Western University, Canada

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-05-04
• Study Start: 2022-10-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Caries lesion progression	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 Outcome Measures

Name	Time	Method
Caries risk assessment	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.

Trial Locations

Locations (1)

Schulich School of Medicine & Dentistry - Western University; 🇨🇦 London, Ontario, Canada