Class I Dental CariesNCT04738604
Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities
A study testing Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany and Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) in people with Class I Dental Caries, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Class I Dental Caries
- What is being tested?
- Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany and Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- 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.
Show all 12Show fewer
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Class I Dental Caries
- Being tested
- Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany, Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany; Other: 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 Receives: Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany; Other: Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (8)
Color Match
Alfa: Matches tooth. Bravo: Acceptable mismatch. Charlie: Unacceptable mismatch.
Measured: 24 months
Marginal Discoloration
Alfa: No discoloration. Bravo: minor marginal discoloration without staining toward pulp. Charlie: Deep discoloration with staining toward pulp.
Measured: 24 months
Marginal Adaptation
Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed.
Measured: 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.
Measured: 24 months
Surface Texture
Alfa: As smooth as the surrounding enamel. Bravo: Surface rougher than enamel, clinically acceptable. Charlie: Surface unacceptably rough.
Measured: 24 months
Marginal Integrity
Alfa: Restoration adapts closely to the tooth structure Bravo: A visible crevice. Charlie: The explorer penetrates into the crevice.
Measured: 24 months
Postoperative sensitivity
Alfa: No post-operative sensitivity. Bravo: Short term and tolerable post-operative sensitivity. Charlie: Intolerable post-operative sensitivity.
Measured: 24 months
Amount of Restoration wear.
Measuring unit: Microns (Quantitative)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class I Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samah mohamed bahig mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738604
- Sponsor's protocol ID
- 91120
- Status last verified
- Aug 2021
- First submitted
- 31 Jan 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40850984
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Wear Resistance of Two Nano Ceramic Resin Composite in Class I Cavities: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04738604
- Acronym / sponsor ID
- 91120
- Conditions
- Class I Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) | Active comparator | Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany, Other: 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 |
| Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany) | Experimental | Other: Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany, Other: Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, 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 |
Who may qualify
- Ages
- 20 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Male or female gender.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceram•X (Dentsply De Trey GmbH, Konstanz, GermanyThe 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 | 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)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. | Other | Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany), Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) |
Primary outcome
Anatomic form
Time frame: 24 months
Bravo: Restoration is under-contoured, without dentin or base exposure Charlie: Restoration is under-contoured, without dentin or base exposure.restoration need replacement.
8 secondary outcomes
Color Match
Time frame: 24 months
Marginal Discoloration
Time frame: 24 months
Marginal Adaptation
Time frame: 24 months
Secondary Caries
Time frame: 24 months
Surface Texture
Time frame: 24 months
Marginal Integrity
Time frame: 24 months
Postoperative sensitivity
Time frame: 24 months
Amount of Restoration wear.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Derived from this study: PubMed 40850984Bahig 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany and Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) in people with Class I Dental Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic form (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04738604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.