Dental Caries Clinical Trial
— SEAL2Official title:
Reparación y Sellado de Restauraciones de Amalgama y Resinas Compuestas Para el Incremento de Su Longevidad Repair and Sealing of Amalgam and Composite Resins to Increase of Longevity
Verified date | July 2017 |
Source | University of Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
the patient (n=60), with at least 3 composite resins with marginal defects , randomized into 3 groups A=Sealed with flow composite reinforced with nanofiller , B= Sealed with resin sealant , and C=Control, without intervention , and then assessed by the FDI criteria for clinical performance and longevity of restorations
Status | Completed |
Enrollment | 60 |
Est. completion date | May 1, 2017 |
Est. primary completion date | December 1, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 or older - High risk of caries. - With restorations of resin composite occlusal, molars or premolars, with values of 3 or 4 for the parameter marginal adaptation according to the FDI criteria. Exclusion Criteria: - Patients with impossibility of mouth opening or dental treatments. - Patients with allergies to any of the materials used. - Presence of adjacent to the restoration or secondary caries. - Patients with prior sealed of their restorations. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Chile |
Fernández E, Martin J, Vildósola P, Estay J, de Oliveira Júnior OB, Gordan V, Mjor I, Gonzalez J, Loguercio AD, Moncada G. Sealing composite with defective margins, good care or over treatment? Results of a 10-year clinical trial. Oper Dent. 2015 Mar-Apr;40(2):144-52. doi: 10.2341/14-143-C. Epub 2014 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Marginal adaptation | ( mm of bridge between tooth and restorations ) | 6 month | |
Primary | Marginal staining, | ( + >50% diameter / - <50% diameter) | 4 years | |
Primary | Retention of seal ( is present + / was loose -) | Loss of restoration | 4 years |
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