Clinical PerformanceNCT05808075
Clinical Performance of Nano Fiber Reinforced Versus Conventional Nano Hybrid Composite in Restoring Premolars
A study testing NovaProTM Fill Universal Dental Composite in people with Clinical Performance, run by Cairo University.
Trial summary
In patients that need composite restorations in a compound proximal carious lesions in premolars, will the clinical performance of nano fiber reinforced resin composite restorations have similar results compared to those restored with conventional nano hybrid resin composite over two years follow up period? Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance
- What is being tested?
- NovaProTM Fill Universal Dental Composite
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Apr 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient ages 18 to 55 years
- Male or Female patients
- Patients with good oral hygiene
- Patients with good recall availability
Who cannot join
- Patient who are allergic to products' ingredients used in the study
- Patients with poor oral hygiene
- Patients with history of bruxism and parafunctional habits
- Patients with high caries index or high plaque index.
- Pregnant or lactating women.
- History of severe medical complications such as xerostomia
About this study
Official title: Clinical Performance of Nano Fiber Reinforced Resin Composite Versus Conventional Nano Hybrid Resin Composite in Restoration of Compound Proximal Carious Lesions in Premolar Teeth: Two Years Randomized Clinical Trial
In patients that need composite restorations in a compound proximal carious lesions in premolars, will the clinical performance of nano fiber reinforced resin composite restorations have similar results compared to those restored with conventional nano hybrid resin composite over two years follow up period?
Read the detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University outpatient clinic. The operator in charge will be DR. The patients in this study will be selected according to different exclusion and inclusion criteria.
Teeth that meet the inclusion criteria will be selected (n=26) and divided into two groups (n=13).
Group (1): NovaProTM Fill Universal Composite (Nanova Columbia.MO. USA).Group (2): Tetric N-Ceram Nano-hybrid (IvoclarVivadent, Schaan, Liechtenstein). Teeth will be cleaned to remove surface stains. Compound proximal cavities will be prepared with rounded internal angles and with non beveled margins. The carious tissues will be removed using diamond burs of the suitable size at high speed under profuse water cooling system. After the cavity preparation and the appropriate shade of resin material selected, all restorations will be performed using a pre-curved metallic sectional matrix associated with a separating ring and a proper sized wooden wedge to establish the anatomical shape and proximal contacts of the teeth. All the restorative materials will be applied according to the manufacturer instructions (n=13)
All participants will be instructed to follow oral hygiene measures (brush the teeth twice a day, floss once a day) to avoid plaque and bacterial accumulation which may negatively affect the performance.
The restorations will be evaluated at baseline (after placement of restoration), after 6, 12, 18 \& 24 months, using Modified United States Public Health Service criteria (USPHS) for the following characteristics: Anatomic Form (Wear), Marginal integrity, Surface roughness, Marginal discoloration, Color match, Recurrent caries, Post-operative sensitivity. The resin composite restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable and Charlie represents a clinically unacceptable situation.
- Conditions
- Clinical Performance
- Being tested
- NovaProTM Fill Universal Dental Composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovaProTM Fill Universal Dental CompositeOther
NovaProTM Fill Universal ,Nanova product
| Study group | Role | What they receive |
|---|---|---|
| NovaProTM Fill Universal Dental Composite | Experimental | NovaProTM Fill Universal Dental Composite will be selected , the tooth will be selectively etched with Phosphoric acid gel (37%) to enamel for 30 seconds .The etchant will be removed and the cavity will be rinsed with water spray for 30 seconds and air dried. A uniform thin layer of the adhesive will be applied on all the prepared surfaces then will be dispersed with a stream of air and then light cured. The restorative material will be applied using an incremental filling technique starting at the gingival wall. The restoration will be cured in 2 mm increments for 20 s. The proximal surfaces will be contoured with finishing strips following manufacturer's instructions. The occlusion will be checked with a thin articulating paper and will be adjusted by removing material with a fine diamond or stone. Finishing will be accomplished by finishing diamond stones then polished using rubber points Receives: Other: NovaProTM Fill Universal Dental Composite |
| Tetric N-Ceram Nano-hybrid Dental Composite | Active comparator | The tooth will be selectively etched with N-Etch (IvoclarVivadent, Schaan, Liechtenstein) Phosphoric acid gel (37%) to enamel for 30 seconds. The etchant will be removed and the cavity will be rinsed with water spray for 30 seconds and dried with air syringe. A Uniform thin layer of the adhesive will be applied on all the prepared surface then dispersed with a stream of air and then light cured (Woodpecker Light Cure LED ,China).The restorative material Tetric N-Ceram Nano-hybrid will be applied using an incremental filling technique starting at the gingival wall. Each increment will be polymerized for 20 seconds., Occlusal adjustments will be made using articulating paper. Finishing will be accomplished by finishing diamond then polished using rubber points Receives: Other: NovaProTM Fill Universal Dental Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic Form
Modified USPHS criteria United States Public Health Service
USPHS criteria United States Public Health Service
Measured: 2 years
Secondary outcomes (1)
Mechanical, Esthetic and Biological properties
Modified USPHS criteria United States Public Health Service
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PerformanceStudies 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
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Raafat Abd-ElMoneim Hafez Khalid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808075
- Sponsor's protocol ID
- 27722
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Nano Fiber Reinforced Resin Composite Versus Conventional Nano Hybrid Resin Composite in Restoration of Compound Proximal Carious Lesions in Premolar Teeth: Two Years Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05808075
- Acronym / sponsor ID
- 27722
- Conditions
- Clinical Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 11 Apr 2023 (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 that need composite restorations in a compound proximal carious lesions in premolars, will the clinical performance of nano fiber reinforced resin composite restorations have similar results compared to those restored with conventional nano hybrid resin composite over two years follow up period?
Detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University outpatient clinic. The operator in charge will be DR. The patients in this study will be selected according to different exclusion and inclusion criteria.
Teeth that meet the inclusion criteria will be selected (n=26) and divided into two groups (n=13).
Group (1): NovaProTM Fill Universal Composite (Nanova Columbia.MO. USA).Group (2): Tetric N-Ceram Nano-hybrid (IvoclarVivadent, Schaan, Liechtenstein). Teeth will be cleaned to remove surface stains. Compound proximal cavities will be prepared with rounded internal angles and with non beveled margins. The carious tissues will be removed using diamond burs of the suitable size at high speed under profuse water cooling system. After the cavity preparation and the appropriate shade of resin material selected, all restorations will be performed using a pre-curved metallic sectional matrix associated with a separating ring and a proper sized wooden wedge to establish the anatomical shape and proximal contacts of the teeth. All the restorative materials will be applied according to the manufacturer instructions (n=13)
All participants will be instructed to follow oral hygiene measures (brush the teeth twice a day, floss once a day) to avoid plaque and bacterial accumulation which may negatively affect the performance.
The restorations will be evaluated at baseline (after placement of restoration), after 6, 12, 18 \& 24 months, using Modified United States Public Health Service criteria (USPHS) for the following characteristics: Anatomic Form (Wear), Marginal integrity, Surface roughness, Marginal discoloration, Color match, Recurrent caries, Post-operative sensitivity. The resin composite restorations will be evaluated with the aid of a dental explorer and an intraoral mirror and visual inspection. The restorations will be scored as follows: Alfa represents the ideal clinical situation, Bravo will be clinically acceptable and Charlie represents a clinically unacceptable situation.
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 |
|---|---|---|
| NovaProTM Fill Universal Dental Composite | Experimental | Other: NovaProTM Fill Universal Dental CompositeNovaProTM Fill Universal Dental Composite will be selected , the tooth will be selectively etched with Phosphoric acid gel (37%) to enamel for 30 seconds .The etchant will be removed and the cavity will be rinsed with water spray for 30 seconds and air dried. A uniform thin layer of the adhesive will be applied on all the prepared surfaces then will be dispersed with a stream of air and then light cured. The restorative material will be applied using an incremental filling technique starting at the gingival wall. The restoration will be cured in 2 mm increments for 20 s. The proximal surfaces will be contoured with finishing strips following manufacturer's instructions. The occlusion will be checked with a thin articulating paper and will be adjusted by removing material with a fine diamond or stone. Finishing will be accomplished by finishing diamond stones then polished using rubber points |
| Tetric N-Ceram Nano-hybrid Dental Composite | Active comparator | Other: NovaProTM Fill Universal Dental CompositeThe tooth will be selectively etched with N-Etch (IvoclarVivadent, Schaan, Liechtenstein) Phosphoric acid gel (37%) to enamel for 30 seconds. The etchant will be removed and the cavity will be rinsed with water spray for 30 seconds and dried with air syringe. A Uniform thin layer of the adhesive will be applied on all the prepared surface then dispersed with a stream of air and then light cured (Woodpecker Light Cure LED ,China).The restorative material Tetric N-Ceram Nano-hybrid will be applied using an incremental filling technique starting at the gingival wall. Each increment will be polymerized for 20 seconds., Occlusal adjustments will be made using articulating paper. Finishing will be accomplished by finishing diamond then polished using rubber points |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient ages 18 to 55 years
- Male or Female patients
- Patients with good oral hygiene
- Patients with good recall availability
Key exclusion criteria (6 listed)
- Patient who are allergic to products' ingredients used in the study
- Patients with poor oral hygiene
- Patients with history of bruxism and parafunctional habits
- Patients with high caries index or high plaque index.
- Pregnant or lactating women.
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 |
|---|---|---|
| NovaProTM Fill Universal Dental CompositeNovaProTM Fill Universal ,Nanova product | Other | NovaProTM Fill Universal Dental Composite, Tetric N-Ceram Nano-hybrid Dental Composite |
Primary outcome
Anatomic Form
Time frame: 2 years
Modified USPHS criteria United States Public Health Service USPHS criteria United States Public Health Service
1 secondary outcome
Mechanical, Esthetic and Biological properties
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- 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 NovaProTM Fill Universal Dental Composite in people with Clinical Performance, 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 4 inclusion and 6 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 11 Apr 2023. 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: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2023.