Clinical trial
Two-Years Clinical Performance of Bulk-Fill High Viscosity Ormocer Versus Methacrylate-Based Resin Composite Restorative Systems: The Effect of Bulk-Fill Low-viscosity Resin Composite Liners in Class II Restorations.
Name
M 11120520
Description
This randomized clinical trial evaluated the clinical performance of class II resin composite restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2 years. The null hypotheses in the study were as follows: (1) Different types of matrix structures (ormocer vs. methacrylate) have no effect on the marginal integrity of restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not affect the marginal or internal adaptation of restorations.
Trial arms
Trial start
2020-01-15
Estimated PCD
2022-04-27
Trial end
2023-06-17
Status
Completed
Treatment
Xtra-fill
the material was placed in bulk.
Arms:
Xtra-fill
x-base
The x-base liner was placed and then veneered with Xtra-fill.
Arms:
X-base
Admira fusion x-tra
bulk placement of the restoration Admira fusion -xtra.
Arms:
Admira fusion x-tra
Admira fusion x-base
Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.
Arms:
Admira fusion x-base
Size
30
Primary endpoint
clinical performance
two years
Eligibility criteria
Inclusion Criteria:
* Patients having at least 4 posterior teeth with moderate occlusal-proximal carious lesions.
* Patients ranging in age from 18 to 30 years.
* patients with normal occlusion.
Exclusion Criteria:
General exclusion criteria:
* Patients having severe chronic periodontitis.
* Patients with orthodontic appliances.
* Abnormal occlusion, parafunctional habits.
* Allergy to any of the materials used in the study. Specific teeth exclusion criteria
* Teeth with irreversible pulpitis or non-vital.
* Fractured or cracked teeth.
* Previously restored teeth.
* Cavities with isthmus larger than intercuspal distance.
* Teeth with deep sub-gingival cavity margins.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-09-13
1 organization
4 products
1 indication
Organization
Mansoura UniversityProduct
Xtra-fillIndication
Dental CariesProduct
x-baseProduct
Admira fusion x-traProduct
Admira fusion x-base