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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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05623423
Enrollment
26
Registered
2022-11-21
Start date
2022-11-30
Completion date
2023-12-30
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shade Match

Keywords

class IV restoration, ORMOCER, methacrylate based composite resin

Brief 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%)

Interventions

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 Composite

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)

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

participant: 1. Age of patient (18-40) years old. 2. Good oral hygiene. Teeth: 1. Having no active pulpal or periodontal conditions. 2. Normal Occlusion. 3. Able to return for follow-up assessments as illustrated by the examiners. -

Exclusion criteria

participant: 1. Patients with Edge-to-Edge occlusion. 2. Patients with high caries index. 3. Patients with uncontrolled para-functional habits (e.g. bruxism or clenching). 4. Patients with inadequate oral hygiene. 5. Patients with periodontal or gingival conditions. 6. Patients with orthodontic appliances. 7. Patients with spontaneous pain or sensitivity to percussion 8. Pregnant Patients -

Design outcomes

Primary

MeasureTime frameDescription
Shade matchT1: 1 week (baseline)measured by Modified USPHS

Secondary

MeasureTime frameDescription
a) Retention rateT1: 1 week (baseline)Modified united states public health service

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026