Non-invasive Caries Management: Clinical Study

NCT ID: NCT04373356

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-09-30

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.

Conditions

Caries,Dental; Caries Arrested

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Resin Infiltration

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Sodium Fluoride Varnish

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Schulich School of Medicine & Dentistry - Western University

London, Ontario, Canada

Countries

Canada

Other Identifiers

115761

Identifier Type: -

Identifier Source: org_study_id