NCT01726179|Completed
Efficacy of Proximal Caries Infiltration
Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
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Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
Sponsor study identifier
interventional
50
1 country
1
Study Start
December 2013
Actual (reported)Primary Completion
December 2017
Actual (reported)Study Completion
December 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2012
Actual (reported)November 14, 2012
Actual (reported)December 2013
Actual (reported)December 2017
Actual (reported)December 2018
Actual (reported)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
Stress reaction during treatment
Immediate
Caries risk
Baseline, 6 months, 1 year, 2 years, 3 years
Caries progression rate
2 years, 3 years
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.
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.
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.
Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.
Rio de Janeiro, 20551-031, Brazil
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.
Vera M Soviero, Prof., Dr.
Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia
50 participants (actual enrollment reported by the registry).
First Submitted
November 1, 2012
First Posted
November 14, 2012
Study Start
December 2013
Actual (reported)Clinical Trial Proximal Caries Infiltration and Detection
Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2017
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
April 26, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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