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Clinical Trials/NCT05623423
NCT05623423
Completed
Not Applicable

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

Cairo University1 site in 1 country26 target enrollmentNovember 30, 2022
ConditionsShade Match

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shade Match
Sponsor
Cairo University
Enrollment
26
Locations
1
Primary Endpoint
Shade match
Status
Completed
Last Updated
last year

Overview

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%)

Registry
clinicaltrials.gov
Start Date
November 30, 2022
End Date
December 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lilly Assem Mousa Ahmed

Investigator, data entry & corresponding author B.D.S. October University for Modern Sciences and Arts (2017). Teaching Assistant at MSA University, 6th Of October, Egypt.

Cairo University

Eligibility Criteria

Inclusion Criteria

  • participant:
  • Age of patient (18-40) years old.
  • Good oral hygiene.
  • 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 -

Outcomes

Primary Outcomes

Shade match

Time Frame: T3: 1 year.

measured by Modified USPHS

Secondary Outcomes

  • a) Retention rate(T3: 1 year)

Study Sites (1)

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