Clinical trial NCT04373356: Non-invasive Caries Management: Clinical Study
Official title: Non-invasive and Minimal Intervention in Dental Caries Management: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Caries Arrested
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Caries lesion progression
timeFrame: One year follow up
Secondary outcomes:
measure: Caries risk assessment
timeFrame: One year follow up
Other outcomes:
Locations:
city: London
country: Canada
facility: Schulich School of Medicine & Dentistry - Western University
state: Ontario
Study officials:
References: