Clinical Significance of Thermo-Viscous CompositeNCT04152460
Clinical Assessment of Preheated Versus Conventional Bulk Fill Resin Composite
A study testing Viscalor Bulk (VOCO,Cuxhaven) and Grandioso x-tra in people with Clinical Significance of Thermo-Viscous Composite, run by Cairo University at 1 site in Egypt.
Trial summary
A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Significance of Thermo-Viscous Composite
- What is being tested?
- Viscalor Bulk (VOCO,Cuxhaven) and Grandioso x-tra
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Jun 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aging more than 18 years .
- Patients with a high level of oral hygiene.
- Patients having at least 12 posterior teeth in occlusion.
- Patients with good likelihood of recall availability.
- Tooth Inclusion :
- Permanent premolars and molars.
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- Moderate to deep compound class II cavities.
- well formed fully erupted .
- Vital with positive reaction to cold and hot stimulus.
Who cannot join
- Participants with general systematic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy Bruxism habits.
- Patients receiving Orthodontic treatment.
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- last experience with allergic reactions against any component of used materials .
- Tooth exclusion :
- Non vital teeth.
- Secondary carious lesions.
- Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial
A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite.
Read the detailed description
Despite the improvements in resin composite materials some drawbacks still compromise the longevity of resin composite the most frequent reported limitations are related to polymerization shrinkage , to overcome these problem attempts have been made to improve the mechanical properties , the high viscosity and material stickiness as well as adaptation of the material to the walls was difficult and unpredictable .
Preheating is a method that decreases resin composite viscosity results in better adaptation and wettability of the prepared cavity walls reducing the microleakage.
A new approach based on therm-viscous technology Viscalor bulk (VOCO, Cuxhaven ) a high Viscous composite material at room and body temperature by heating to 68 C converted to flowable consistency.
Preheating composite regarding the lab research have significant clinical advantages as better adaptation reduced leakage and increase of mechanical properties .
Follow up Period will be 1 year , Evaluation will be done at baseline , after 6 months and 12 months .
- Being tested
- Viscalor Bulk (VOCO,Cuxhaven), Grandioso x-tra
- Keywords
- Bulk-fill resin Composite, Thermo-Viscous resin Composite, Proximal Compound Cavities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viscalor Bulk (VOCO,Cuxhaven)Device
Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)
Grandioso x-traOther
Nanohybrid Bulk Resin Composite
| Study group | Role | What they receive |
|---|---|---|
| Thermo-Viscous preheated bulk fill resin composite | Active comparator | Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps) Receives: Device: Viscalor Bulk (VOCO,Cuxhaven) |
| Conventional Bulk Fill resin Composite | Placebo comparator | GrandioSo X-tra (Voco,Cuxhaven Receives: Other: Grandioso x-tra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Integrity
Modified US Public Health Service Criteria (USPHS)
Measured: 1 year
Secondary outcomes (1)
Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )
Modified US Public Health Service Criteria (USPHS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 May 2020
- Primary completion1 May 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Significance of Thermo-Viscous CompositeStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Atef Ahmed Ibrahim, Cairo University
- Investigators
- Olfat Hasanen, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152460
- Sponsor's protocol ID
- PHD-CU-2019-10-29
- Status last verified
- Feb 2021
- First submitted
- 3 Nov 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Thermo-Viscous Conventional Bulk-fill Resin Composite in Proximal Compound Posterior Restorations : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04152460
- Acronym / sponsor ID
- PHD-CU-2019-10-29
- Keywords
- Bulk-fill resin Composite, Thermo-Viscous resin Composite, Proximal Compound Cavities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 5 Nov 2019 (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.
A Randomized clinical trial to evaluate the clinical assessment of thermo-viscous versus conventional bulk fill resin composite in proximal compound posterior teeth.The null hypothesis is that there is no difference between thermo-viscous and conventional bulk fill resin composite.
Detailed description
Despite the improvements in resin composite materials some drawbacks still compromise the longevity of resin composite the most frequent reported limitations are related to polymerization shrinkage , to overcome these problem attempts have been made to improve the mechanical properties , the high viscosity and material stickiness as well as adaptation of the material to the walls was difficult and unpredictable .
Preheating is a method that decreases resin composite viscosity results in better adaptation and wettability of the prepared cavity walls reducing the microleakage.
A new approach based on therm-viscous technology Viscalor bulk (VOCO, Cuxhaven ) a high Viscous composite material at room and body temperature by heating to 68 C converted to flowable consistency.
Preheating composite regarding the lab research have significant clinical advantages as better adaptation reduced leakage and increase of mechanical properties .
Follow up Period will be 1 year , Evaluation will be done at baseline , after 6 months and 12 months .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermo-Viscous preheated bulk fill resin composite | Active comparator | Device: Viscalor Bulk (VOCO,Cuxhaven)Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps) |
| Conventional Bulk Fill resin Composite | Placebo comparator | Other: Grandioso x-traGrandioSo X-tra (Voco,Cuxhaven |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients aging more than 18 years .
- Patients with a high level of oral hygiene.
- Patients having at least 12 posterior teeth in occlusion.
- Patients with good likelihood of recall availability.
- Permanent premolars and molars.
Key exclusion criteria (11 listed)
- Participants with general systematic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability to comply with study procedures.
- Heavy Bruxism habits.
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 |
|---|---|---|
| Viscalor Bulk (VOCO,Cuxhaven)Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps) | Device | Thermo-Viscous preheated bulk fill resin composite |
| Grandioso x-traNanohybrid Bulk Resin Composite | Other | Conventional Bulk Fill resin Composite |
Primary outcome
Marginal Integrity
Time frame: 1 year
Modified US Public Health Service Criteria (USPHS)
1 secondary outcome
Clinical Evaluation of restoration ( Marginal discoloration,secondary caries and Postoperative Sensitivity )
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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.
Olfat Hasanen principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viscalor Bulk (VOCO,Cuxhaven) and Grandioso x-tra in people with Clinical Significance of Thermo-Viscous Composite, run by Cairo University at 1 site 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 9 inclusion and 11 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Marginal Integrity (time frame: 1 year). 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 16 Feb 2021.