Clinical PerformanceNCT05334901
Performance of Curing Times and Intensitis
A study testing High intensity light cure in people with Clinical Performance, run by Cairo University at 2 sites in Egypt.
Trial summary
The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for 1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical performance of bulk fill resin composite restorations in compound Class II cavities of posterior teeth Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Performance
- What is being tested?
- High intensity light cure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesEgypt
- Study dates
- 22 Apr 2022to 22 Oct 2022
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Permanent premolars or molars.
- Moderate to deep compound class II cavities.
- Vital with the positive reaction to a cold thermal stimulus.
- Absence of parafunctional habits
Who cannot join
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Secondary carious lesions.
- Advanced periodontal disease
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Dentistry
Cairo, 002
Faculty of Dentistry
Giza, Cairo Governorate, 002
About this study
Official title: Effect of Different Curing Times and Intensities on The Performance of Compound Class II Bulk-Fill Resin Composite Restorations: (An In-Vivo and In-Vitro Study)
The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for 1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical performance of bulk fill resin composite restorations in compound Class II cavities of posterior teeth
Read the detailed description
The prepared cavities will be conditioned with 35% phosphoric acid gel for15 seconds, then will be rinsed and dried with compressed air. Then application of universal adhesive system to all cavity with bond brush then light cured for 10 seconds using LED light curing unit (1200 mw/cm2). Extra-Fill bulk fill resin composite will be applied in onebulk increment and will be light polymerized for 1 second using (LED) light curing unit (2200 mw/cm2).for intervention group Extra-Fill bulk fill resin composite will be applied in one bulk increment and will be light polymerized for 20 seconds using (LED) light curing unit (1200 mw/cm2) fot control group
- Conditions
- Clinical Performance
- Being tested
- High intensity light cure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity light cureDevice
Bulk fill resin composite restoration cured with high intensity light curing (2200 mw/cm2)To achieve increased power and a wider spectrum for short exposure time (1 second) to overcome resin composite restoration techniques sensitivity and shorten the clinical procedure
| Study group | Role | What they receive |
|---|---|---|
| High intensity light cure | Experimental | High intensity light curing (2200 mw/cm2)To achieve increased power and a wider spectrum for short exposure time (1 second) to overcome resin composite restoration techniques sensitivity and shorten the clinical procedure Receives: Device: High intensity light cure |
| Low intensity light cure | Active comparator | Conventional light curing (1200 mw/cm2) for long exposure time (20 seconds) to achieve the slower rate of conversion allowing for a better flow of the material, which decreases contraction stress in the filling material Receives: Device: High intensity light cure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance
Clinical performance of bulk fill resin composite restorations will be evaluated by modified USPHS Criteria includes:
- Marginal Discoloration
- Marginal adaptation
- Secondary caries
- Postoperative sensitivity
For each criteria one score will be chosen from 3 scores (Alpha,Bravo\&Charlie).
Measured: Change from the baseline at 6 months and12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start22 Apr 2022
- Primary completion22 Apr 2022
- Study completion22 Oct 2022
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roaa Sabry, Cairo University
- Investigators
- Roaa Azazy, Master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334901
- Sponsor's protocol ID
- OPR 22/3/2022
- Status last verified
- Nov 2023
- First submitted
- 22 Mar 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for 1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical performance of bulk fill resin composite restorations incompound Class II cavities of posterior teeth
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Curing Times and Intensities on The Performance of Compound Class II Bulk-Fill Resin Composite Restorations: (An In-Vivo and In-Vitro Study)
- ClinicalTrials.gov ID
- NCT05334901
- Acronym / sponsor ID
- OPR 22/3/2022
- Conditions
- Clinical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 19 Apr 2022 (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.
The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for 1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical performance of bulk fill resin composite restorations in compound Class II cavities of posterior teeth
Detailed description
The prepared cavities will be conditioned with 35% phosphoric acid gel for15 seconds, then will be rinsed and dried with compressed air. Then application of universal adhesive system to all cavity with bond brush then light cured for 10 seconds using LED light curing unit (1200 mw/cm2). Extra-Fill bulk fill resin composite will be applied in onebulk increment and will be light polymerized for 1 second using (LED) light curing unit (2200 mw/cm2).for intervention group Extra-Fill bulk fill resin composite will be applied in one bulk increment and will be light polymerized for 20 seconds using (LED) light curing unit (1200 mw/cm2) fot control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity light cure | Experimental | Device: High intensity light cureHigh intensity light curing (2200 mw/cm2)To achieve increased power and a wider spectrum for short exposure time (1 second) to overcome resin composite restoration techniques sensitivity and shorten the clinical procedure |
| Low intensity light cure | Active comparator | Device: High intensity light cureConventional light curing (1200 mw/cm2) for long exposure time (20 seconds) to achieve the slower rate of conversion allowing for a better flow of the material, which decreases contraction stress in the filling material |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Permanent premolars or molars.
- Moderate to deep compound class II cavities.
- Vital with the positive reaction to a cold thermal stimulus.
- Absence of parafunctional habits
Key exclusion criteria (4 listed)
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
- Non-vital teeth.
- Secondary carious lesions.
- Advanced periodontal disease
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 |
|---|---|---|
| High intensity light cureBulk fill resin composite restoration cured with high intensity light curing (2200 mw/cm2)To achieve increased power and a wider spectrum for short exposure time (1 second) to overcome resin composite restoration techniques sensitivity and shorten the clinical procedure | Device | High intensity light cure, Low intensity light cure |
Primary outcome
Clinical performance
Time frame: Change from the baseline at 6 months and12 months
Clinical performance of bulk fill resin composite restorations will be evaluated by modified USPHS Criteria includes: * Marginal Discoloration * Marginal adaptation * Secondary caries * Postoperative sensitivity For each criteria one score will be chosen from 3 scores (Alpha,Bravo\&Charlie).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Yes. The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for 1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical performance of bulk fill resin composite restorations incompound Class II cavities of posterior teeth
Related trials for Clinical Performance
Active, not recruitingObservational study
Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples
Diquat Poisoning
Recruiting
A Clinical Study of the Aqua Therapeutics Thermal Therapy Vapor Ablation System in Premenopausal Women With Abnormal Uterine Bleeding
Menorrhagia
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Not yet recruiting
3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars
Dental Restorations in Children, Pediatric Dentistry
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
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.
Roaa Azazy, Master principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity light cure in people with Clinical Performance, run by Cairo University at 2 sites in Egypt.
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 4 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: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performance (time frame: Change from the baseline at 6 months and12 months). 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 6 Dec 2023.