Efficacy of Proximal Caries Infiltration

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

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.

Study Overview

• Status: Completed
• Conditions: Caries; Dental Health
• Intervention / Treatment: Device: Resin infiltration; Device: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 20551-031
    • Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resin infiltration; This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day. Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.	Device: Resin infiltration; 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
Other: Control; This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day. Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.	Device: Control; Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries progression rate	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress reaction during treatment	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.	Immediate
Caries risk	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.	Baseline, 6 months, 1 year, 2 years, 3 years
Caries progression rate	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.	2 years, 3 years

Collaborators and Investigators

• Sponsor: DMG Dental Material Gesellschaft mbH
• Collaborators: Rio de Janeiro State Research Supporting Foundation (FAPERJ); Universidade Federal do Rio de Janeiro
• Investigators: Principal Investigator: Vera M Soviero, Prof., Dr., Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia

Publications and helpful links

General Publications

• Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017-2227-7. Epub 2017 Oct 8.
• Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: November 1, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: dental anxiety; caries infiltration; caries arrest; dental stress; resin infiltration
• Other Study ID Numbers: ECIPRJ13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No