Non-invasive Caries Management: Clinical Study

NCT04373356 | Completed DMC

• 1 other identifier: 115761
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries,Dental; Caries Arrested

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Caries risk assessment

  One year follow up

Study Arms (2)

Resin Infiltration

EXPERIMENTAL

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

Sodium Fluoride Varnish

ACTIVE COMPARATOR

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

Interventions

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.

Resin Infiltration

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.

Sodium Fluoride Varnish

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Schulich School of Medicine & Dentistry - Western University

London, Ontario, N6A 3K7, Canada

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 4, 2020
• Study Start: October 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)