search
Back to results

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

Primary Purpose

Dental Caries on Smooth Surface Limited to Enamel, Tooth Demineralization, Dental Caries

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ICON DMG Resin Infiltration (micro-invasive approach)
ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries on Smooth Surface Limited to Enamel focused on measuring Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests

Eligibility Criteria

18 Years - 43 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Ege University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Flouride Varnish applications (non-invasive approaches)

Resin Infiltration (micro-invasive approaches)

Arm Description

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

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

Outcomes

Primary Outcome Measures

The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale
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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2021
Last Updated
January 20, 2022
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT05202665
Brief Title
Resin Infiltration and Fluoride Varnish Lesion Arresting Efficacy on Non-cavitated Proximal Lesion
Official Title
The Evaluation of Resin Infiltration or Fluoride Varnish Effect on Non-cavited Proximal Caries Lesion Progress at Individuals Modarate/High Caries Risk
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 26, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries on Smooth Surface Limited to Enamel, Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests, Cariogram
Keywords
Tooth Demineralization, Dental Caries, Dentistry, Operative, Dental Caries Activity Tests

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flouride Varnish applications (non-invasive approaches)
Arm Type
Experimental
Arm Description
ClinproTM White Varnish 22600 ppm, 3M ESPE was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion.
Arm Title
Resin Infiltration (micro-invasive approaches)
Arm Type
Experimental
Arm Description
ICON DMG was applied in line with the manufacturer's recommendation to non-cavitated proximal caries lesion.
Intervention Type
Procedure
Intervention Name(s)
ICON DMG Resin Infiltration (micro-invasive approach)
Intervention Description
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
Intervention Name(s)
ClinproTM White Varnish, 3M ESPE Fluoride Varnish (non-invasive approach)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale
Description
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
Time Frame
The patients follow-up time was anticipated for 60 months in 6-month periods with ten intervals.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Ercan Devrimci, PhD
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University Faculty of Dentistry
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.karger.com/Article/FullText/275573
Description
Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: Efficacy after 1 year
URL
http://link.springer.com/10.1007/s00784-017-2314-9
Description
MI varnish and MI paste plus in a caries prevention and remineralization study: A randomized controlled trial

Learn more about this trial

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

We'll reach out to this number within 24 hrs