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

Not Applicable

• Conditions: Tooth Demineralization; Dental Caries; Cariogram; Dental Caries on Smooth Surface Limited to Enamel; Dentistry, Operative; Dental Caries Activity Tests
• Interventions: Procedure: ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach); Procedure: ICON DMG Resin Infiltration (micro-invasive approach)

• Registration Number: NCT05202665
• Lead Sponsor: Ege University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-26
• Primary Completion: 2018-03-30
• Study First Submitted: 2021-12-20
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-20
• Last Update Submitted: 2022-01-20
• Study First Posted: 2022-01-21
• Last Update Posted: 2022-01-21
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flouride Varnish applications (non-invasive approaches)	ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)	ClinproTM White Varnish 22600 ppm, 3M ESPE was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion.
Resin Infiltration (micro-invasive approaches)	ICON DMG Resin Infiltration (micro-invasive approach)	ICON DMG was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion.

Primary Outcome Measures

Name	Time	Method
The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale	The patients follow-up time was anticipated for 60 months in 6-month periods with ten intervals.	The non-cavitated proximal carious lesion progression as measured by radiographic lesion depth scale, radiographic score change from baseline with radiographic lesion depth scale over 60 months in 6-month periods.; Description of the radiographic lesion depth scale scores used in this study: E1 = radiolucency in outer half of enamel E2 = radiolucency in inner half of enamel D1= radiolucency in outer third of dentine

Trial Locations

Locations (1)

Ege University Faculty of Dentistry; 🇹🇷 Izmir, Bornova, Turkey