Randomized controlled clinical trial evaluating Filtek Bulk Fill Posterior Restorative in a split-mouth study desig
- Conditions
- The objective of the study is to evaluate the clinical survival and quality parameters of posterior composite resin restorations made with Filtek Bulk Fill Posterior Restorative over a follow-up period of five years and to compare it with data yielded from intra-individual control restorations (split-mouth) made of Filtek Supreme XTE.
- Registration Number
- DRKS00013799
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Subject Inclusion Criteria
• Male or female patients diagnosed for restorative treatment using composite resin restorations on two or more posterior teeth (molars, premolars)
• Aged 18 – 80
• Good general health
Restoration Inclusion Criteria
• Class-II restoration on posterior tooth (molars, premolars)
• Restoration with antagonist and at least one proximal contact
• Good prognosis of tooth – 5 year survival of tooth can be expected
• Class II restoration requiring replacement of one cusp are only included if both Class II restorations of the same individual require replacement of one cusp
Subject Exclusion Criteria
• Patient is pregnant or nursing
• Dental personnel or dental student
• Severely neglected oral hygiene
• Disabilities or reduced manual dexterity that may interfere with normal oral hygiene procedures
Restoration Exclusion Criteria
• Severe periodontal disease (Periodontal Community Screening Index Grade 4, i.e. periodontal probing depth =6mm) on tooth to be treated
• Extensive tooth substance loss requiring replacement of more than one cusp
• Pulpitic pain before treatment or pulp exposure during treatment
• Non-vital teeth
• Signs of parafunctions / bruxism
• Known allergies against any of the study substances
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival of restorations after 1, 2, 3 and 5 years.<br><br>Definition of overall survival: Restorations which are in-situ and completely intact at follow-up will be recorded as overall survival (score 1 through 3 in all categories of the Hickel/FDI criteria).<br><br>In case any type of failure (score 5) or unfavorable event (score 4) happened during the follow-up period the restoration will be classified as a failure.
- Secondary Outcome Measures
Name Time Method Quality parameters of restorations <br><br>Definition of quality parameter: FDI clinical criteria and scoring system.