NCT04738604

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

January 31, 2021

Last Update Submit

August 30, 2021

Conditions

Class I Dental Caries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Color Match

    24 months

  • Marginal Discoloration

    24 months

  • Marginal Adaptation

    24 months

  • Secondary Caries

    24 months

  • Surface Texture

    24 months

  • +3 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

Ceram•X (Dentsply De Trey GmbH, Konstanz, GermanyOTHER

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.

Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany)Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)
Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)OTHER

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.

Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany)Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)

Eligibility Criteria

Age20 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bahig SM, El Sherbiney HH, Zayed MM, Ibrahim SH. A comparative 48 month randomized trial of clinical performance and wear of BISGMA based and BISGMA free nanoceramic resin composites. Sci Rep. 2025 Aug 25;15(1):31167. doi: 10.1038/s41598-025-16865-x.

    PMID: 40850984DERIVED

MeSH Terms

Interventions

CeramX

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

March 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
expecting to have all the data by October 2022