Clinical trial NCT05202665: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The non-cavitated proximal caries lesion progression change as measured by radiographic lesion depth scale
timeFrame: The patients follow-up time was anticipated for 60 months in 6-month periods with ten intervals.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Faculty of Dentistry
state: Bornova
Study officials:
affiliation: Ege University
name: Elif Ercan Devrimci, PhD
role: STUDY_CHAIR
References: