Clinical Trials Directory

Trials / Completed

CompletedNCT05623423

Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin

Evaluation of Clinical Performance of Class IV Restoration Using Organically Modified Ceramic (OMNOCER) in Comparison to a Methacrylate Based Composite Resin a Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

Summary

Evaluation of clinical performance of class IV restoration using organically modified ceramic (ORMOCER) in comparison to a Methacrylate Based Composite Resin: A randomized clinical trial

Detailed description

Statement of the problem: Resin composites have been the most popular material in esthetic dentistry since 1960's. Esthetic restorative material should resemble the natural tooth; in both color match and stability, and should have adequate strength, wear and sealing characteristics . Longevity of anterior restorations varied in earlier studies depending on the restorative material and cavity class. Involvement of the incisal angle in anterior teeth resulted in accompanied reduction in average survival time. In contrast to class I, II, III and V cavity configurations, class IV restorations are stressed at the incisal angle, posing a challenge to the tooth restoration interface. Because the majority of class IV restorations lack mechanical retention; the tooth-bonded interface faces additional obstacles. In addition, color is one of the most important factors of esthetic restorations, since color change may be due to intrinsic factors as; changes in the filler, matrix and silane coating as well as extrinsic staining; as absorption of stains, chemical reactivity, diet and oral hygiene. But the recent advances in the resin composite restoration in their monomer chemistry, filler type and structure have been continuously developed to improve their mechanical and physical properties. Rationale: In order to optimize the properties of the material and facilitate deeper light transmission, manufacturers incorporated an advanced composite filler technology and resin matrix modifications by introducing Organically Modified Ceramics with pure silicate technology showing superior material properties, which was claimed to be better than Methacrylate Based Composite Resin. Moreover, polymerization shrinkage stresses depend on many factors, like composition of resin matrix, quantity of filler and degree of conversion. Ormocer induces polymerization as a result of a matrix of long inorganic silica chains with organic lateral chains. This type of Ormocer enhances aesthetics, color stability, abrasion resistance, and reduces polymerization shrinkage and surface roughness due to the presence of ceramic polysiloxane, which has low degree of polymerization shrinkage (1.25%)

Conditions

Interventions

TypeNameDescription
OTHER(Admira Fusion, Voco GmbH, Germany)cavity margins will be extended to the proximal area, incisal edge, facial and lingual surfaces All enamel margins will be beveled at a 45° angle to the external cavosurface.(approximately 0.5-2.0 mm) An impression for the upper anterior teeth will be taken to produce a silicon palatal index The proximal margins of the restorations will be achieved using the Unica anterior matrix teeth will be etched using 37% phosphoric acid gel for 30 s then rinsed with air water for 20 s A single coat of universal bond cured using and LED light curing unit for 10 s Using the chosen enamel shade of the ORMOCER Resin Composite a thin layer (0.5-1 mm) Unica matrix will used to produce the proximal margins of the restorations Contouring, finishing and polishing of the restoration will be done Dental floss and finishing strips will be used Rubber dam will then be removed and occlusion will be checked using an articulating paper
OTHERMethacrylate Based CompositeThe exact same steps as in the intervention will be done but using the chosen shades of Methacrylate Based Composite Resin. (Ceram.X Spectra ST, Dentsply Sirona, UK)

Timeline

Start date
2022-11-30
Primary completion
2023-12-30
Completion
2023-12-30
First posted
2022-11-21
Last updated
2024-06-04

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05623423. Inclusion in this directory is not an endorsement.