Efficacy of Proximal Caries Infiltration
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dental Health Caries |
Device: Icon infiltration Device: control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial |
- caries progression after infiltration [ Time Frame: 1 yr, 2 yrs, 3 yrs ] [ Designated as safety issue: No ]To test the efficacy of caries infiltration with a low viscosity resin (Infiltrant; DMG, Hamburg, Germany) in controlling the progression of non-cavitated proximal lesions in primary molars in comparison to conventional non invasive treatment (daily plaque control brushing with fluoride dentifrice and flossing).
- stress reaction during treatment [ Time Frame: baseline ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 66 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Icon infiltration
Icon infiltration regarding instructions for use
|
Device: Icon infiltration
Patients and their guardians will be instructed to use dental floss to remove dental biofilm in both proximal sites once a day and to brush teeth with fluorated toothpaste twice a day. Besides that, test lesion will be infiltrated with a low viscosity resin (Icon, DMG, Hamburg, Germany). The test lesions will be treated using Icon (DMG, Hamburg, Germany) following the instruction for use. A sub-sample with children with indication for a composite restoration in at least one proximal surface will be selected for the analysis of dental anxiety and stress. |
|
Active Comparator: control
conventional non invasive treatment
|
Device: control
Patients and their guardians will be instructed to use dental floss to remove dental biofilm in both proximal sites once a day and to brush teeth with fluoridated toothpaste twice a day. A sub-sample with children with indication for a composite restoration in at least one proximal surface will be selected for the analysis of dental anxiety and stress. |
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| Ages Eligible for Study: | 5 Years to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Vera M Soviero, Prof., Dr. | +(21) 25 87 63 72 | verasoviero@gmail.com |
| Contact: Ivete PR de Souza, Prof., Dr. | +(21) 25 62 21 01 |
| Brazil | |
| Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia. | Not yet recruiting |
| Rio de Janeiro, Brazil, 20551-031 | |
| Contact: Vera M Soviero, Prof., Dr. +(21) 25 87 63 72 verasoviero@gmail.com | |
| Contact: Ivete PR de Souza, Prof., Dr. +(21) 25 62 21 01 | |
| Principal Investigator: Vera M Soviero, Prof., Dr. | |
| Sub-Investigator: Ivete PR de Souza, Prof., Dr. | |
| Sub-Investigator: Michelle Ammari, Dr. | |
| Principal Investigator: | Vera Mendes Soviero, Prof., Dr. | Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia. Boulevard 28 de Setembro, 157 Vila Isabel 20551-031 - Rio de Janeiro, RJ Brasil |
More Information
No publications provided
| Responsible Party: | DMG Dental Material Gesellschaft mbH |
| ClinicalTrials.gov Identifier: | NCT01726179 History of Changes |
| Other Study ID Numbers: | ECIPRJ13 |
| Study First Received: | November 1, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Brazil: Comissão Nacional de Ética em Pesquisa (Conep) |
Keywords provided by DMG Dental Material Gesellschaft mbH:
|
caries infiltration caries arrest dental anxiety dental stress |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013