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

September 23, 2023 updated by: Lilly Assem Mousa Ahmed, Cairo University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nermeen Hamza, Ass Professor
  • Phone Number: 01211110660
  • Email: nhamza@msa.edu.eg

Study Locations

  • Egypt
      • Cairo, Egypt, 00202
        • Recruiting
        • Cairo University
        • Contact:
          • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Mostafa Abdulhameed, Professor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

November 6, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 23, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • class IV restoration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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