Status:
ACTIVE_NOT_RECRUITING
Clinical Evaluation of "Cention Forte" Restorative Material
Lead Sponsor:
Istanbul Medipol University Hospital
Collaborating Sponsors:
Ivoclar Vivadent AG
Conditions:
Caries
Unsatisfactory or Defective Restoration of Tooth
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Resin composites, the first choice of material for the restoration of posterior teeth, still have several drawbacks including their polymerization shrinkage and potential failure of the resin-dentin i...
Detailed Description
The aim of the study is to place at least 90 posterior restorations with Cention (in at least 45 patients). The patients will be informed about the study and ask to sign the Informed Consent. After ha...
Eligibility Criteria
Inclusion
- Vital tooth checked with sensibility test towards cold
- Proximal and/or occlusal caries lesion to be treated invasively or restoration that needs replacement (i.e. amalgam, composite, glass-ionomer)
- Class I \& II restorations in premolar and molars (at least 75% Class II).
- Maximum 2 fillings with Cention 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) Moderate or high caries activity: DMFS equivalent or higher than mean DMFS of the population of the same age group in the same region or city.
- No untreated periodontal disease (only DPSI 1, 2)
- Subjects had to be over the age of 18, 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
- Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
- Endodontic treatment
- Pulp exposure or near pulp exposure
- Patients who want to bleach their teeth or bleached teeth less than 3 weeks ago
- Extremely hypersensitive tooth (s. below) / Pulpitis 7 VAS (visual analog scale) \>3 on temperature and/or biting
- Excluding the teeth, without opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
- Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
- Subjects undergoing orthodontic treatment
- 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 :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04796974
Start Date
March 8 2021
End Date
July 8 2025
Last Update
July 10 2024
Active Locations (1)
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1
Istanbul Medipol University, Dental Hospital
Istanbul, Turkey (Türkiye), 34083