Non-invasive Caries Management: Clinical Study (NICM)

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

Study Overview

• Status: Completed
• Conditions: Caries,Dental; Caries Arrested
• Intervention / Treatment: Device: Resin Infiltration; Device: Sodium Fluoride Varnish

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Schulich School of Medicine & Dentistry - Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Resin Infiltration; 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.
Active Comparator: 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.	Device: Sodium Fluoride Varnish; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries lesion progression	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.	One year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries risk assessment	Evaluate non-invasive and minimally-invasive therapies on the progression of the caries lesions correlated with the patient's caries risk.	One year follow up

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: 115761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No