Randomized Clinical TrialBioactiveNCT04365283
New Bioactive Restorative Material vs GIC in Restoration of Proximal Lesions
A study testing New Bioactive Restorative Material (ACTIVA Presto) and High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte) in people with Randomized Clinical Trial, run by Rana Ayman Kamal.
Trial summary
ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Randomized Clinical Trial
- What is being tested?
- New Bioactive Restorative Material (ACTIVA Presto) and High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 May 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
- No healthy volunteers
- Adult
Who may be able to join
- Proximal lesions in posterior premolars and molars and Age 20-40 years
Who cannot join
- Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of New Bioactive Restorative Material Versus High Viscosity Glass Hybrid Reinforced Glass Ionomer in Restoration of Proximal Lesions: A Randomized Clinical Trial
ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.
Read the detailed description
High caries risk patients are those who have high DMF index, high sugar intake, poor oral hygiene, inadequate salivary flow, low pH level, as well as deficient fluoride exposure.
Therefore, their management has to be adequate and proper. To overcome these setbacks, glass ionomer cements that have advantages such as similar coefficient of thermal expansion to natural tooth tissue, physicochemical adhesion to tooth structure, biocompatability, fluoride release, low shrinkage and low marginal leakage as well as anticaries properties and increased remineralization interproximally ,which is especially beneficial in high risk caries patients, have been considered as an alternative restorative material to composite and amalgam. To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified glass ionomer (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. Progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment. ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.
Activa Presto light-cured material from Pulpdent is the company's latest product that features biomimicry as Activa Bioactive dual-cured material. The material diffuses fluoride, calcium, and phosphate ions that fortify the saliva and help replace essential minerals that are lost in the decay process. This highly esthetic, light-cured resin contains these ions in a stackable resin matrix that holds its shape and does not slump. This durable product is resistant to fracturing and wear, especially so on the thin areas of enamel bevels, and is indicated for all restorative procedures replacing dentin and/or enamel, anterior or posterior.
- Conditions
- Randomized Clinical Trial
- Being tested
- New Bioactive Restorative Material (ACTIVA Presto), High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Bioactive Restorative Material (ACTIVA Presto)Procedure or surgery
New Bioactive Restorative Material
High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)Other
High Viscosity Glass Hybrid Reinforced Glass Ionomer
| Study group | Role | What they receive |
|---|---|---|
| New Bioactive Restorative Material | Experimental | ACTIVA Presto restorative material Receives: Procedure: New Bioactive Restorative Material (ACTIVA Presto) |
| High Viscosity Glass Hybrid Reinforced Glass Ionomer | Active comparator | EQUIA Forte restorative material Receives: Other: High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Contact (modified USPHS criteria)
Ordinal(Alfa/Bravo/Charlie)
Measured: 6 months
Proximal Contact (modified USPHS criteria)
Ordinal(Alfa/Bravo/Charlie)
Measured: 1 Year
Secondary outcomes (2)
Retention(modified USPHS criteria)
Ordinal(Alpha/Charlie)
Measured: 6 Months
Retention(modified USPHS criteria)
Ordinal(Alpha/Charlie)
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 posted28 Apr 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Clinical TrialStudies of the same condition, open and under way.
- 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, Care provider, Investigator
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rana Ayman Kamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rana Ayman Kamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365283
- Sponsor's protocol ID
- 25091992
- Acronym
- Bioactive
- Status last verified
- Sep 2020
- First submitted
- 20 Apr 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of New Bioactive Restorative Material Versus High Viscosity Glass Hybrid Reinforced Glass Ionomer in Restoration of Proximal Lesions: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04365283
- Acronym / sponsor ID
- Bioactive / 25091992
- Conditions
- Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Rana Ayman KamalUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 28 Apr 2020 (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.
ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.
Detailed description
High caries risk patients are those who have high DMF index, high sugar intake, poor oral hygiene, inadequate salivary flow, low pH level, as well as deficient fluoride exposure.
Therefore, their management has to be adequate and proper. To overcome these setbacks, glass ionomer cements that have advantages such as similar coefficient of thermal expansion to natural tooth tissue, physicochemical adhesion to tooth structure, biocompatability, fluoride release, low shrinkage and low marginal leakage as well as anticaries properties and increased remineralization interproximally ,which is especially beneficial in high risk caries patients, have been considered as an alternative restorative material to composite and amalgam. To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified glass ionomer (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. Progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment. ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.
Activa Presto light-cured material from Pulpdent is the company's latest product that features biomimicry as Activa Bioactive dual-cured material. The material diffuses fluoride, calcium, and phosphate ions that fortify the saliva and help replace essential minerals that are lost in the decay process. This highly esthetic, light-cured resin contains these ions in a stackable resin matrix that holds its shape and does not slump. This durable product is resistant to fracturing and wear, especially so on the thin areas of enamel bevels, and is indicated for all restorative procedures replacing dentin and/or enamel, anterior or posterior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Bioactive Restorative Material | Experimental | Procedure: New Bioactive Restorative Material (ACTIVA Presto)ACTIVA Presto restorative material |
| High Viscosity Glass Hybrid Reinforced Glass Ionomer | Active comparator | Other: High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)EQUIA Forte restorative material |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Proximal lesions in posterior premolars and molars and Age 20-40 years
Key exclusion criteria (1 listed)
- Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities
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 |
|---|---|---|
| New Bioactive Restorative Material (ACTIVA Presto)New Bioactive Restorative Material | Procedure or surgery | New Bioactive Restorative Material |
| High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)High Viscosity Glass Hybrid Reinforced Glass Ionomer | Other | High Viscosity Glass Hybrid Reinforced Glass Ionomer |
Primary outcome
Proximal Contact (modified USPHS criteria)
Time frame: 6 months
Ordinal(Alfa/Bravo/Charlie)
Proximal Contact (modified USPHS criteria)
Time frame: 1 Year
Ordinal(Alfa/Bravo/Charlie)
2 secondary outcomes
Retention(modified USPHS criteria)
Time frame: 6 Months
Retention(modified USPHS criteria)
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 22 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing New Bioactive Restorative Material (ACTIVA Presto) and High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte) in people with Randomized Clinical Trial, run by Rana Ayman Kamal.
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 1 inclusion and 1 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 22 Sep 2020. 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?
Contact Rana Kamal, BDS (01226000747 ext. 12, rana.ayman747@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Contact (modified USPHS criteria) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 22 Sep 2020.