Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion

Ege University

Status: Unknown

Conditions: Tooth Demineralization; Dental Caries; Dental Caries Activity Tests; Dental Caries on Smooth Surface Limited to Enamel; Cariogram; Dentistry, Operative

Treatments: Procedure: ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach); Procedure: ICON DMG Resin Infiltration (micro-invasive approach)

Study type: Interventional

Funder types: Other

Identifiers

NCT05202665

70198063-050.06.04/17-8/7

Details and patient eligibility

About

Protection of dental hard tissues is one of the most important points of cariology. For this purpose, oral hygiene training (effective brushing and motivation), non-invasive approaches such as flouride varnish applications and micro-invasive approaches such as resin infiltration technique are applied in clinical practice. In this study, the effect of resin infiltration or fluoride varnish application on lesion depth in individuals with moderate/high caries risk was investigated.

The study was a randomized controlled, prospective and parallel designed clinical trial. 60 patients were included in the study and patients were randomly allocate to the groups. Caries risk of individuals was determined according to Cariogram, which is a computer program․ According to visual clinical examination, stage the caries continuum were (ICDAS 1,2) scored and the caries diagnostic criteria scored acording to (Nyvad 1, 2, 4, 5) The teeth wich has one caries lesion in border of enamel or prolonged to first 1/3 part of dentin in bite-wing radiograph (lesion level: E1, E2, D1) included in this study. Patient's gingival condition evaluating at initial and control sessions with gingival index (0=healthy, 1=mild inflammation, 2=moderate inflammation and bleeding on pressure). Oral hygiene training was given to all subjects included in the study and the use of fluoride toothpaste (1450 ppm, NaF) was recommended. This study was performed in a single center by experienced physicians. Resin infiltration (Icon DMG, USA) was applied to one of the groups(n=30), while fluoride varnish (ClinproTM White Varnish 22600 ppm, 3M ESPE, USA) was applied to the other group(n=30). The patients follow-up time was anticipated for 60 months in 6-month periods. The inicial visual clinical examination(T0) and follow-up sessions (T 1, 2, 3, 4, 5, 6, 7, 8, 9, 10) were conducted by two experienced researchers blind to the group information. At the aim of the study, evaluation difference in non-cavited proximal lesion progression between the resin infiltration (micro-invasive) and fluoride varnish (non-invasive) treatment options at the individuals with moderate or high risk of caries.

Enrollment: 60 patients

Sex: All

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• individuals with moderate/high risk of caries
• the presence of one or more noncavitated interproximal caries lesions with radiolucencies involving the outher half of enamel up to the outer third of dentin in bite-wing radiographies (lesion depth: E1, E2, D1)
• vital posterior teeth without cavitation in which the clinically active non-carious lesion had
• Only one tooth per patient was included in the study

Exclusion criteria

• incapable of contracting
• pregnancy
• presence of secondary caries or restoration in the involved tooth
• lack of contact teeth
• incapable of contracting

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Flouride Varnish applications (non-invasive approaches)

Experimental group

Description:

ClinproTM White Varnish 22600 ppm, 3M ESPE was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion.

Treatment:

Procedure: ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)

Resin Infiltration (micro-invasive approaches)

Experimental group

Description:

ICON DMG was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion.

Treatment:

Procedure: ICON DMG Resin Infiltration (micro-invasive approach)