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

Not Applicable

Completed

• Conditions: Shade Match
• Interventions: Other: Methacrylate Based Composite; Other: (Admira Fusion, Voco GmbH, Germany)

• Registration Number: NCT05623423
• Lead Sponsor: Cairo University

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%)

Study Timeline

• Study First Submitted: 2022-11-06
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-21
• Study Start: 2022-11-30
• Status Verified: 2022-12
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methacrylate Based Composite	Methacrylate Based Composite	(Ceram.X Spectra ST, Dentsply Sirona, UK)
Organically Modified Ceramic (ORMOCER) Resin Composite.	(Admira Fusion, Voco GmbH, Germany)	(Admira Fusion, Voco GmbH, Germany)

Primary Outcome Measures

Name	Time	Method
Shade match	T3: 1 year.	measured by Modified USPHS

Secondary Outcome Measures

Name	Time	Method
a) Retention rate	T3: 1 year	Modified united states public health service

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt