Non-invasive Caries Management: Clinical Study

Caries,Dental Clinical Trial

— NICM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04373356
• Other study ID #: 115761
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2020
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries Arrested
• Caries,Dental
• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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