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

Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities: A Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Class I Dental Caries
• Intervention / Treatment: Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany; Other: Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany); 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	Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany; 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.; Other: Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany); 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.
Experimental: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany); 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	Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany; 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.; Other: Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color Match	Alfa: Matches tooth. Bravo: Acceptable mismatch. Charlie: Unacceptable mismatch.	24 months
Marginal Discoloration	Alfa: No discoloration. Bravo: minor marginal discoloration without staining toward pulp. Charlie: Deep discoloration with staining toward pulp.	24 months
Marginal Adaptation	Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed.	24 months
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.	24 months
Surface Texture	Alfa: As smooth as the surrounding enamel. Bravo: Surface rougher than enamel, clinically acceptable. Charlie: Surface unacceptably rough.	24 months
Marginal Integrity	Alfa: Restoration adapts closely to the tooth structure Bravo: A visible crevice. Charlie: The explorer penetrates into the crevice.	24 months
Postoperative sensitivity	Alfa: No post-operative sensitivity. Bravo: Short term and tolerable post-operative sensitivity. Charlie: Intolerable post-operative sensitivity.	24 months
Amount of Restoration wear.	Measuring unit: Microns (Quantitative)	24 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 31, 2021
• First Submitted That Met QC Criteria: January 31, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 91120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: expecting to have all the data by October 2022
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No