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

NCT ID: NCT05202665

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-26
• Study Completion Date: 2022-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Flouride Varnish applications (non-invasive approaches)

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Tooth surfaces were cleaned thoroughly and isolated with cotton rolls. According to the manufacturer's instructions, the unit dose packages were opened, and the contents were dispensed onto the application guide and mixed to avoid the separation of sodium fluoride components. A thin coat of varnish (ClinproTM White Varnish, 3M ESPE, USA) with 22600 ppm fluoride was applied to the tooth interface with a brush tip applicator and waited for 5 minutes. Aproximal areas were coated with dental floss. The patient was instructed not to rinse or apply suction immediately after application. Patients were advised to avoid eating hard and sticky foods or drinking hot beverages for the next 2 hours, to consume a soft diet immediately after 30 minutes and to avoid brushing and flossing for the rest of the day.

Resin Infiltration (micro-invasive approaches)

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

Group Type: EXPERIMENTAL

ICON DMG Resin Infiltration (micro-invasive approach)

Intervention Type: PROCEDURE

A plastic wedge located below the contact point to apart from the surface from adjacent tooth. A 15% HCl etching gel (Icon, DMG, Hamburg, Germany) was applied by syringe below the contact point for 120 s. After, the gel was washed off with air-water-spray for 30 s. The lesion was desiccated by air-blowing for 10 s, application of ethanol for 30 s and air-blowing again for 30 s. A resin infiltrant (Icon, DMG, Hamburg, Germany) was applied with another plastic holder during 3 min. Following the penetration, excess of material was removed by air blowing and flossing. The resin was light-cured for 40 s total from the buccal, occlusal, and lingual/palatal aspects. It was needed to reapplicate the resin infiltration for once because of infiltrating remaining porosities during 1 minute. Excess material removing process was again repeated and light cured for 40 s.

Interventions

ICON DMG Resin Infiltration (micro-invasive approach)

A plastic wedge located below the contact point to apart from the surface from adjacent tooth. A 15% HCl etching gel (Icon, DMG, Hamburg, Germany) was applied by syringe below the contact point for 120 s. After, the gel was washed off with air-water-spray for 30 s. The lesion was desiccated by air-blowing for 10 s, application of ethanol for 30 s and air-blowing again for 30 s. A resin infiltrant (Icon, DMG, Hamburg, Germany) was applied with another plastic holder during 3 min. Following the penetration, excess of material was removed by air blowing and flossing. The resin was light-cured for 40 s total from the buccal, occlusal, and lingual/palatal aspects. It was needed to reapplicate the resin infiltration for once because of infiltrating remaining porosities during 1 minute. Excess material removing process was again repeated and light cured for 40 s.

Intervention Type: PROCEDURE

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

Tooth surfaces were cleaned thoroughly and isolated with cotton rolls. According to the manufacturer's instructions, the unit dose packages were opened, and the contents were dispensed onto the application guide and mixed to avoid the separation of sodium fluoride components. A thin coat of varnish (ClinproTM White Varnish, 3M ESPE, USA) with 22600 ppm fluoride was applied to the tooth interface with a brush tip applicator and waited for 5 minutes. Aproximal areas were coated with dental floss. The patient was instructed not to rinse or apply suction immediately after application. Patients were advised to avoid eating hard and sticky foods or drinking hot beverages for the next 2 hours, to consume a soft diet immediately after 30 minutes and to avoid brushing and flossing for the rest of the day.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

TIJEN PAMIR

Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elif Ercan Devrimci, PhD

Role: STUDY_CHAIR

Ege University

Locations

Ege University Faculty of Dentistry

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

http://journals.sagepub.com/doi/10.1177/0022034518800014

Nonrestorative Treatments for Caries: Systematic Review and Network Meta-analysis

http://journals.sagepub.com/doi/10.1177/0022034519876853

Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial

http://link.springer.com/10.1007/s00784-017-2314-9

MI varnish and MI paste plus in a caries prevention and remineralization study: A randomized controlled trial

Other Identifiers

70198063-050.06.04/17-8/7

Identifier Type: -

Identifier Source: org_study_id