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Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities

Primary Purpose

Class I Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany
Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class I Dental Caries

Eligibility Criteria

20 Years - 54 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Male or female gender.

    • Only co-operative patients approving to participate in the trial.
    • Good oral hygiene.
    • Medically free adult patients.
    • The age range of the patients is 20 to 54 years
    • Vital first and second molars, with Class I lesion.
    • Functioning tooth with presence of an opposing.
    • Healthy periodontium

Exclusion Criteria:

  • Patients with disabilities.
  • Patients having systemic diseases or severe medically compromised.
  • Individuals with full dentures or crowns and bridges in occlusal contact with teeth indicated for the restorative treatment
  • Pregnant or lactating subjects, or intending to become pregnant during the course of the study
  • Poor oral hygiene.
  • Teeth with pulpal pain.
  • Teeth with periapical lesions.
  • Endodontically treated teeth
  • Teeth with mobility.
  • Non-functioning tooth with no opposing tooth.
  • Heavy occlusion or signs of severe attrition.
  • Severe periodontal affection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)

    Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany)

    Arm Description

    Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) is the ideal choice for single-tooth restorations, both in the anterior and the posterior region. It has an ultrafine, radiopaque porcelain filler for use in adhesive filling treatment. It can be polished to a high lustrer due to the ultra- fine particle filler, extremely homogeneous restorations can be placed which are easily polished to a high luster. The mechanical properties of a light-cured dental composite material are particularly dependent on its filler content, the type of incorporated fillers and the efficiency of the filler-resin coupling, so high Vickers hardness, compressive strength and flexural strength are recorded refereed to Zenit filler content 83% by weight (70% by volume) and size 0.7 microns

    contains organically modified ceramic nanoparticles (2 to 3 nm) and nano-fillers (10 nm) that are combined with conventional glass fillers (mean particle size: 1.1 to 1.5 μm). Nanoparticles and nano-fillers comprise a polysiloxane backbone and have methacrylate groups available for polymerization. According to the manufacturer's data, filler concentration is 76% by weight and 57% by volume. Furthermore, most of the conventional resin matrix is replaced by a matrix full of highly dispersed methacrylate modified polysiloxane particles (2- 3 nm).These nano-ceramic particles are inorganic-organic hybrid particles. Both, nano-ceramic particles and nano- fillers have methacrylate groups available for polymerization. CeramX does not contain triethylene glycol dimethacrylate (TEGDMA) as it was found mutagenic and cytotoxic in vitro

    Outcomes

    Primary Outcome Measures

    Anatomic form
    Bravo: Restoration is under-contoured, without dentin or base exposure Charlie: Restoration is under-contoured, without dentin or base exposure.restoration need replacement.

    Secondary Outcome Measures

    Color Match
    Alfa: Matches tooth. Bravo: Acceptable mismatch. Charlie: Unacceptable mismatch.
    Marginal Discoloration
    Alfa: No discoloration. Bravo: minor marginal discoloration without staining toward pulp. Charlie: Deep discoloration with staining toward pulp.
    Marginal Adaptation
    Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed.
    Secondary Caries
    Alfa: No active caries present. Bravo: Non-cavitated active caries is present in contact with the restoration. Charlie: Cavitated active caries is present in contact with the restoration.
    Surface Texture
    Alfa: As smooth as the surrounding enamel. Bravo: Surface rougher than enamel, clinically acceptable. Charlie: Surface unacceptably rough.
    Marginal Integrity
    Alfa: Restoration adapts closely to the tooth structure Bravo: A visible crevice. Charlie: The explorer penetrates into the crevice.
    Postoperative sensitivity
    Alfa: No post-operative sensitivity. Bravo: Short term and tolerable post-operative sensitivity. Charlie: Intolerable post-operative sensitivity.
    Amount of Restoration wear.
    Measuring unit: Microns (Quantitative)

    Full Information

    First Posted
    January 31, 2021
    Last Updated
    August 30, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04738604
    Brief Title
    Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities
    Official Title
    Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    in patients with Class I Cavities, will the use of Zenit Nano Ceramic Composite restorations have similar clinical performance to conventional Ceram-X Nano Ceramic Composite restorations, evaluation of restorations will be done at baseline, six, and twelve months using Modified USPHS Ryge criteria.
    Detailed Description
    The study will be conducted in the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University; the operator in charge samah mohamed bahig, The subjects fulfilling the eligibility criteria of the trial will be selected from the regular attendees at the clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University. Patient examination will be done including medical history, dental history, extra-oral examination and intraoral examination. A periapical radiograph will be taken prior to restorative procedures to assess the degree of approximation of caries to pulp, intactness of lamina dura and/or presence of any periapical radiolucency to exclude the case. The field of operation will be isolated with the application of a rubber dam if possible. Otherwise, cotton rolls and the saliva ejector will be used for moisture control. For cavity preparation, local anesthetic (MepecaineL, Alexandria Company, Egypt) solution will be administrated to control patient discomfort during the procedure. The cavities will be prepared by using cylindrical #314 (Komet®, Germany) in a high speed handpiece (Sirona, Germany) rotating at high speed with copious coolant. Remaining soft caries -if present- will be removed using sharp excavator (Maillefer, Dentsuply, Switzerland).After the cavity preparation is finished, it will be thoroughly air-water cleaned. The bonding system; the Prime and Bond universal adhesive (Dentsply De Trey GmbH, Konstanz, Germany) will be applied according to the following instructions recommended by the manufacturer and rubbed for 20 seconds then blown with a gentle air blow for 5 seconds to evaporate the solvent and then light curing for 10 seconds using LED light curing unit (>700 mW/cm2).The prepared cavities will be restored with Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) will be applied with incremental placement technique (maximum: 2-mm layer). Increments will be light curing for 40 seconds according to manufacturer's instructions. and for the control group cavities will be restored withCeram•X (Dentsply De Trey GmbH, Konstanz, Germany) with incremental placement technique (maximum: 2-mm layer). Increments will be light cured for 20 seconds according to manufacturer's instructions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Class I Dental Caries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)
    Arm Type
    Active Comparator
    Arm Description
    Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) is the ideal choice for single-tooth restorations, both in the anterior and the posterior region. It has an ultrafine, radiopaque porcelain filler for use in adhesive filling treatment. It can be polished to a high lustrer due to the ultra- fine particle filler, extremely homogeneous restorations can be placed which are easily polished to a high luster. The mechanical properties of a light-cured dental composite material are particularly dependent on its filler content, the type of incorporated fillers and the efficiency of the filler-resin coupling, so high Vickers hardness, compressive strength and flexural strength are recorded refereed to Zenit filler content 83% by weight (70% by volume) and size 0.7 microns
    Arm Title
    Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany)
    Arm Type
    Experimental
    Arm Description
    contains organically modified ceramic nanoparticles (2 to 3 nm) and nano-fillers (10 nm) that are combined with conventional glass fillers (mean particle size: 1.1 to 1.5 μm). Nanoparticles and nano-fillers comprise a polysiloxane backbone and have methacrylate groups available for polymerization. According to the manufacturer's data, filler concentration is 76% by weight and 57% by volume. Furthermore, most of the conventional resin matrix is replaced by a matrix full of highly dispersed methacrylate modified polysiloxane particles (2- 3 nm).These nano-ceramic particles are inorganic-organic hybrid particles. Both, nano-ceramic particles and nano- fillers have methacrylate groups available for polymerization. CeramX does not contain triethylene glycol dimethacrylate (TEGDMA) as it was found mutagenic and cytotoxic in vitro
    Intervention Type
    Other
    Intervention Name(s)
    Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany
    Intervention Description
    The prepared cavities will be restored with Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany) with incremental placement technique (maximum: 2-mm layer). Increments will be light curing for 20 seconds according to manufacturer's instructions.
    Intervention Type
    Other
    Intervention Name(s)
    Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)
    Intervention Description
    The prepared cavities will be restored with Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) with incremental placement technique (maximum: 2-mm layer). Increments will be light curing for 40 seconds according to manufacturer's instructions.
    Primary Outcome Measure Information:
    Title
    Anatomic form
    Description
    Bravo: Restoration is under-contoured, without dentin or base exposure Charlie: Restoration is under-contoured, without dentin or base exposure.restoration need replacement.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Color Match
    Description
    Alfa: Matches tooth. Bravo: Acceptable mismatch. Charlie: Unacceptable mismatch.
    Time Frame
    24 months
    Title
    Marginal Discoloration
    Description
    Alfa: No discoloration. Bravo: minor marginal discoloration without staining toward pulp. Charlie: Deep discoloration with staining toward pulp.
    Time Frame
    24 months
    Title
    Marginal Adaptation
    Description
    Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed.
    Time Frame
    24 months
    Title
    Secondary Caries
    Description
    Alfa: No active caries present. Bravo: Non-cavitated active caries is present in contact with the restoration. Charlie: Cavitated active caries is present in contact with the restoration.
    Time Frame
    24 months
    Title
    Surface Texture
    Description
    Alfa: As smooth as the surrounding enamel. Bravo: Surface rougher than enamel, clinically acceptable. Charlie: Surface unacceptably rough.
    Time Frame
    24 months
    Title
    Marginal Integrity
    Description
    Alfa: Restoration adapts closely to the tooth structure Bravo: A visible crevice. Charlie: The explorer penetrates into the crevice.
    Time Frame
    24 months
    Title
    Postoperative sensitivity
    Description
    Alfa: No post-operative sensitivity. Bravo: Short term and tolerable post-operative sensitivity. Charlie: Intolerable post-operative sensitivity.
    Time Frame
    24 months
    Title
    Amount of Restoration wear.
    Description
    Measuring unit: Microns (Quantitative)
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    54 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Male or female gender. Only co-operative patients approving to participate in the trial. Good oral hygiene. Medically free adult patients. The age range of the patients is 20 to 54 years Vital first and second molars, with Class I lesion. Functioning tooth with presence of an opposing. Healthy periodontium Exclusion Criteria: Patients with disabilities. Patients having systemic diseases or severe medically compromised. Individuals with full dentures or crowns and bridges in occlusal contact with teeth indicated for the restorative treatment Pregnant or lactating subjects, or intending to become pregnant during the course of the study Poor oral hygiene. Teeth with pulpal pain. Teeth with periapical lesions. Endodontically treated teeth Teeth with mobility. Non-functioning tooth with no opposing tooth. Heavy occlusion or signs of severe attrition. Severe periodontal affection

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    expecting to have all the data by October 2022

    Learn more about this trial

    Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities

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