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

Study Overview
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Brief Summary
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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
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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%)

Official Title
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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

Conditions
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Shade Match

Intervention / Treatment
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* Other: (Admira Fusion, Voco GmbH, Germany)
* Other: Methacrylate Based Composite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participant: Age of patient (18-40) years old. Good oral hygiene. Teeth: Having no active pulpal or periodontal conditions. Normal Occlusion. Able to return for follow-up assessments as illustrated by the examiners. - Exclusion Criteria: participant: Patients with Edge-to-Edge occlusion. Patients with high caries index. Patients with uncontrolled para-functional habits (e.g. bruxism or clenching). Patients with inadequate oral hygiene. Patients with periodontal or gingival conditions. Patients with orthodontic appliances. Patients with spontaneous pain or sensitivity to percussion Pregnant Patients -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organically Modified Ceramic (ORMOCER) Resin Composite.<br>(Admira Fusion, Voco GmbH, Germany) | Other: (Admira Fusion, Voco GmbH, Germany)<br>* 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<br>|
| Active Comparator: Methacrylate Based Composite<br>(Ceram.X Spectra ST, Dentsply Sirona, UK) | Other: Methacrylate Based Composite<br>* The 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shade match | measured by Modified USPHS | T1: 1 week (baseline) | 
| Shade match | measured by Modified USPHS | T2: 3 months | 
| Shade match | measured by Modified USPHS | T3: 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a) Retention rate | Modified united states public health service | T1: 1 week (baseline) | 
| a) Retention rate | Modified united states public health service | T2: 3 months | 
| a) Retention rate | Modified united states public health service | T3: 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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class IV restoration, ORMOCER, methacrylate based composite resin