Efficacy of Proximal Caries Infiltration
This trial is active, not recruiting.
|Conditions||dental health, caries|
|Treatments||icon infiltration, control|
|Sponsor||DMG Dental Material Gesellschaft mbH|
|Collaborator||Universidade Federal do Rio de Janeiro|
|Start date||December 2012|
|End date||December 2016|
|Trial size||66 participants|
|Trial identifier||NCT01726179, ECIPRJ13|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (investigator)|
caries progression after infiltration
time frame: 1 yr, 2 yrs, 3 yrs
stress reaction during treatment
time frame: baseline
Male or female participants from 5 years up to 7 years old.
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
|Official title||Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial|
|Principal investigator||Vera Mendes Soviero, Prof., Dr.|
|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.|
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