Status:
COMPLETED
Clinical Evaluation of ELS Versus ELS Extra Resin Composite
Lead Sponsor:
Istanbul Medipol University Hospital
Collaborating Sponsors:
Saremco
Conditions:
Caries, Dental
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Adhesive restorative materials are routinely used in operative dentistry to improve tooth tissues with minimal preparation, achieve more esthetic and long term restorations. Despite these efficacy to ...
Detailed Description
The detrimental impact of resin composite polymerization shrinkage on restoration interface quality and stability has been recognized since the early use of this material is still one of the major dra...
Eligibility Criteria
Inclusion
- Primary caries removal
- Class I \& II restoration replacement
- No obvious untreated caries, dental health problems (regularly checked by a dentist)
- Good or moderate oral hygiene (plaque score of less than 30% in anterior region be-fore treatment)
- No untreated periodontal disease (only DPSI 1, 2)
- Subjects had to present no active carious lesions
- 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 good oral hygiene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
- 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
- Caries extends cemento-enamel junction in Class II.
- 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 with extensive loss of tooth tissue
- Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
- Excluding the teeth, with 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 who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
- Subjects who were pregnant pregnant during the duration of the study
- Subjects who are known to be allergic to the ingredients of resin materials
Key Trial Info
Start Date :
December 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03306576
Start Date
December 10 2017
End Date
December 30 2020
Last Update
March 1 2023
Active Locations (1)
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1
Istanbul Medipol University, Dental School
Istanbul, Turkey (Türkiye), 34083