Status:
UNKNOWN
Clinical Evaluation of Posterior Indirect Resin Composite Restorations With PBE
Lead Sponsor:
Istanbul Medipol University Hospital
Collaborating Sponsors:
Ivoclar Vivadent AG
Conditions:
Unsatisfactory or Defective Restoration of Tooth
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Evaluation of posterior indirect resin composite restorations with proximal box elevation technique. Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with cove...
Detailed Description
The rehabilitation of decayed or fractured posterior teeth using an indirect technique was introduced for large cavities with coverage of one or more cusps. Problems of biological nature and technical...
Eligibility Criteria
Inclusion
- Vital or endodontically treated posterior teeth with extensive substance loss
- Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)
- Large posterior defects with at least one or more cuspal coverage in molars
- Proximal defects extending below CEJ and at least one or more cavity margin/margins located beneath the gingival tissues
- Maximum 2 indirect restorations with SR Nexco material in each patient
- No obvious untreated caries in the rest of the dentition, dental health problems (regularly checked by a dentist)
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)
- No untreated periodontal disease (only DPSI 1, 2)
- Subjects had to be over 18 years of age, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
- Appropriate isolation after cavity preparations
- Subjects had to agree to keep the scheduled recall appointments for data collection and maintenance and plan to stay in the area for at least 3 years.
Exclusion
- Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3 2. Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Poor endodontic prognosis
- Pulp exposure
- Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
- Extremely hypersensitive tooth
- Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
- Substance loss due to developmental anomalies (hypoplasia, amelogenesis imperfecta etc.)
- Subjects who presented severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
- Subjects who are pregnant or breast feeding during the duration of the study
- Subjects who are known to be allergic to the ingredients of resin materials
Key Trial Info
Start Date :
September 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03832829
Start Date
September 11 2018
End Date
September 1 2025
Last Update
June 9 2023
Active Locations (1)
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1
Istanbul Medipol University, Dental School
Istanbul, Turkey (Türkiye), 34083