Clinical trial NCT01726179: Efficacy of Proximal Caries Infiltration
Official title: Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Health
Caries
Keywords: caries infiltration
caries arrest
dental anxiety
dental stress
resin infiltration
Lead sponsor: DMG Dental Material Gesellschaft mbH
Sponsor class: INDUSTRY
Collaborators: name: Universidade Federal do Rio de Janeiro
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2012-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caries progression rate
timeFrame: 1 year
Secondary outcomes:
measure: Stress reaction during treatment
timeFrame: Immediate
measure: Caries risk
timeFrame: Baseline, 6 months, 1 year, 2 years, 3 years
measure: Caries progression rate
timeFrame: 2 years, 3 years
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.
Study officials:
affiliation: Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia
name: Vera M Soviero, Prof., Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.