Clinical Performance Using Modified USPHS CriteriaActivaPrestoNCT04363996
Bioactive Restorative vs GIC Modified Glass Ionomer in Restoration of Cervical Lesions: Randomized Controlled Trial
A study testing New Bioactive Restorative Material in people with Clinical Performance Using Modified USPHS Criteria, run by Cairo University at 1 site in Egypt.
Trial summary
Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical… 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 Using Modified USPHS Criteria
- What is being tested?
- New Bioactive Restorative Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cervical carious lesions anterior teeth and premolars.
- Age 20-40 years.
Who cannot join
- Rampant caries.
- Pregnancy.
- Disabilities.
- Oral Dryness.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 002
Ahmed Rozeik, MSc, 01118079308, said.rozeik@gmail.com
About this study
Official title: Clinical Evaluation of New Bioactive Restorative Material Versus Resin Modified Glass Ionomer in Restoration of Cervical Lesions: Randomized Controlled Trial
Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent).
Read the detailed description
The resin composites used with bonding agents are popularly used for the restoration of cervical lesions. These materials exhibit high strength and physical properties as well as good esthetic property but they don't offer the chemical bonding and fluoride release potentials necessary for managing high caries risk patients (Khoroushi et al., 2012).
Fluorides containing restorative materials have been advocated as the material of choice for restoring cervical lesions in high caries risk patients since this kind of material offers chemical bonding, fluoride release, and caries inhibiting potentials. Conventional Glass Ionomer and Resin modified glass ionomer restorative materials have high fluoride release and could be specified clinically to repair cervical lesions in high caries risk patients. However, clinical acceptance of these materials has been limited because of their low tensile strength, brittleness, and low resistance to wear (Somani et al., 2016).
Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent). Activa Presto light-cured material from Pulpdent is the company's newest product that features biomimicry as Activa Bioactive dual-cured material. It is available in a 1.2 mL syringe for easy application, and no longer need for a special dispensing gun to apply the material. Consequently, placement of the resin is precise and highly adaptive to the cavity margins. It is highly radiopaque (250%), so it can be easily followed on radiographs.
There are eight esthetic shades: A1, A2, A3, A3.5, B1, BW and two new darker cervical shades A4 and A6 which can be useful in geriatric patients. 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 (ACTIVA Presto - Pulpdent).
- Being tested
- New Bioactive Restorative Material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Bioactive Restorative MaterialOther
Filling material
| Study group | Role | What they receive |
|---|---|---|
| New Bioactive Restorative Material | Experimental | Activa Presto Bioactive restorative material Receives: Other: New Bioactive Restorative Material |
| Resin Modified Glass Ionomer | Active comparator | Fuji II Receives: Other: New Bioactive Restorative Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface texture
ordinal Criteria Scoring system (ordinal)
Measured: 6 months
Surface texture
ordinal
Measured: 1 year
Secondary outcomes (2)
Marginal adaptation
ordinal
Measured: 6 months
Marginal adaptation
ordinal
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 posted27 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2020 (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 Clinical Performance Using Modified USPHS CriteriaStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amera Nabel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363996
- Sponsor's protocol ID
- 1176
- Acronym
- ActivaPresto
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 27 Apr 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 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of New Bioactive Restorative Material Versus Resin Modified Glass Ionomer in Restoration of Cervical Lesions: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04363996
- Acronym / sponsor ID
- ActivaPresto / 1176
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 27 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.
Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent).
Detailed description
The resin composites used with bonding agents are popularly used for the restoration of cervical lesions. These materials exhibit high strength and physical properties as well as good esthetic property but they don't offer the chemical bonding and fluoride release potentials necessary for managing high caries risk patients (Khoroushi et al., 2012).
Fluorides containing restorative materials have been advocated as the material of choice for restoring cervical lesions in high caries risk patients since this kind of material offers chemical bonding, fluoride release, and caries inhibiting potentials. Conventional Glass Ionomer and Resin modified glass ionomer restorative materials have high fluoride release and could be specified clinically to repair cervical lesions in high caries risk patients. However, clinical acceptance of these materials has been limited because of their low tensile strength, brittleness, and low resistance to wear (Somani et al., 2016).
Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent). Activa Presto light-cured material from Pulpdent is the company's newest product that features biomimicry as Activa Bioactive dual-cured material. It is available in a 1.2 mL syringe for easy application, and no longer need for a special dispensing gun to apply the material. Consequently, placement of the resin is precise and highly adaptive to the cavity margins. It is highly radiopaque (250%), so it can be easily followed on radiographs.
There are eight esthetic shades: A1, A2, A3, A3.5, B1, BW and two new darker cervical shades A4 and A6 which can be useful in geriatric patients. 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 (ACTIVA Presto - Pulpdent).
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 |
|---|---|---|
| New Bioactive Restorative Material | Experimental | Other: New Bioactive Restorative MaterialActiva Presto Bioactive restorative material |
| Resin Modified Glass Ionomer | Active comparator | Other: New Bioactive Restorative MaterialFuji II |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Cervical carious lesions anterior teeth and premolars.
- Age 20-40 years.
Key exclusion criteria (4 listed)
- Rampant caries.
- Pregnancy.
- Disabilities.
- Oral Dryness.
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 MaterialFilling material | Other | New Bioactive Restorative Material, Resin Modified Glass Ionomer |
Primary outcome
Surface texture
Time frame: 6 months
ordinal Criteria Scoring system (ordinal)
Surface texture
Time frame: 1 year
ordinal
2 secondary outcomes
Marginal adaptation
Time frame: 6 months
Marginal adaptation
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 27 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Clinical Performance Using Modified USPHS Criteria
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Diabetes Mellitus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Bioactive Restorative Material in people with Clinical Performance Using Modified USPHS Criteria, 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 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2020. 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. 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 Amera 1 Nabel, BDS (01099872098 ext. 12, anm2sg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface texture (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 27 Apr 2020.