Efficacy of Proximal Caries Infiltration

NCT01726179 | Completed

• 1 other identifier: ECIPRJ13
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Health; Caries

Keywords

caries infiltration; caries arrest; dental anxiety; dental stress; resin infiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Stress reaction during treatment

  Immediate

• Caries risk

  Baseline, 6 months, 1 year, 2 years, 3 years

• Caries progression rate

  2 years, 3 years

Study Arms (2)

Resin infiltration

EXPERIMENTAL

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

Control

OTHER

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

Interventions

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.

Also known as: Icon (DMG, Germany), Approximal resin infiltration kit

Resin infiltration

Control DEVICE

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

Control

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• DMG Dental Material Gesellschaft mbH: lead
• Universidade Federal do Rio de Janeiro: collaborator
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

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

Rio de Janeiro, 20551-031, Brazil

Location

Related Publications (2)

• 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.

  PMID: 28990122 RESULT

• 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.

  PMID: 31465818 RESULT

Study Officials

• Vera M Soviero, Prof., Dr.

  Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 14, 2012
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 26, 2022

Record last verified: 2022-04

Locations

BR (1)