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Completed

NCT Number: NCT01726179

Efficacy of Proximal Caries Infiltration

The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.

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Key information

Conditions

Dental Health Caries

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.

Rio de Janeiro, 20551-031, Brazil

About this study

The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children with one tooth surface with active caries lesions
  • two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
  • asigned informed consent.

Exclusion criteria

  • children who do not cooperate during dental appointments
  • primary molars supposed to exfoliate in less than two years
  • lesions showing obvious cavitation or clear sings of inactivity

Treatment and study plan

Resin infiltration

Device

Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.

Other names: Icon (DMG, Germany), Approximal resin infiltration kit

Control

Device

Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.

Primary outcomes

  1. Caries progression rate

    Time frame: 1 year

    Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.

Secondary outcomes

  1. Stress reaction during treatment

    Time frame: Immediate

    To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.

    A facial image scale with five faces ranging from very happy (1) to very unhappy (5) will be used.

  2. Caries risk

    Time frame: Baseline, 6 months, 1 year, 2 years, 3 years

    Caries risk is asses based on caries index (Nyvad criteria), proximal plaque index (0 = no visible plaque; 1 = visible plaque) and gingival bleeding index (0 = no bleeding after flossing; 1 = bleeding after flossing), dietary habits, and exposition to fluorides based on the Cariogram model.

  3. Caries progression rate

    Time frame: 2 years, 3 years

    Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression in long term. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.

Sponsors and collaborators

Lead sponsor

DMG Dental Material Gesellschaft mbH

Industry

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Universidade Federal do Rio de Janeiro

Registry information

Official study title

Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Nov 14, 2012
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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