10 Years Evaluation of Composite Restoration

Dental Restoration, Permanent Clinical Trial

Official title:

Marginal Quality of Posterior Microhybrid Resin Composite Restorations Applied Using Two Polymerisation Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764450
• Other study ID #: TEX-10y-2016
• Status: Completed
• Phase: N/A
• First received: April 8, 2016
• Last updated: May 5, 2016
• Start date: April 2004

Study information

• Verified date: May 2016
• Source: BNM Clinic and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised, split-mouth clinical study evaluated the marginal quality of direct Class I and Class II restorations made of microhybrid composite and applied using two polymerisation protocols,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• subjects at least 18 years old,

• require restorations due to primary caries in contralateral quadrants with opposing and adjacent tooth contact,

• having no restoration in the antagonist,

Exclusion Criteria

• allergic to resin-based materials,

• pregnant or nursing,

• periodontal disease

Related Conditions & MeSH terms

• Dental Restoration, Permanent

Intervention

Device:
• Astralis 10 HPM
The cavity to be filled is in quadrant I or III
• Astralis 10 RM
The cavity to be filled is in quadrant II or IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BNM Clinic and Research

References & Publications (1)

Barabanti N, Gagliani M, Roulet JF, Testori T, Ozcan M, Cerutti A. Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial. J Dent. 2013 May;41(5):436-42. doi: 10.1016/j.jdent.2013.02.009. Epub 2013 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cavity filled with problem in marginal adaptation and in marginal discoloration	Marginal quality of posterior microhybrid resin composite restorations applied using two polymerisation protocols: 5-year randomised split mouth trial.; The evaluation was done using both SQUACE and USPHS criteria	5 years