Caries, DentalPhase 1/2NCT03779893
Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars
A Phase 1/2 study testing BioCoat® by Premier®. and 3M™ Clinpro™ Sealant. in people with Caries, Dental, run by Cairo University.
Trial summary
This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- BioCoat® by Premier®. and 3M™ Clinpro™ Sealant.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Mar 2020
- Phase
- Phase 1/2
- 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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
- 19 - 40 years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
Who cannot join
- Patients younger than 19 years old or older than 40 years old.
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
- Rampant caries.
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- Heavy smoking.
- Xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
About this study
Official title: Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial
This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination \& VistaCAM.
Read the detailed description
In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.
With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.
- Conditions
- Caries, Dental
- Being tested
- BioCoat® by Premier®., 3M™ Clinpro™ Sealant.
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCoat® by Premier®.Combination product
Bioactive pits and fissure sealant
3M™ Clinpro™ Sealant.Combination product
conventional pits and fissure sealant
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | Conventional resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant is administrated Receives: Combination Product: 3M™ Clinpro™ Sealant. |
| bioactive group | Experimental | Bioactive Pits \& fissures sealant BioCoat® by Premier®. Receives: Combination Product: BioCoat® by Premier®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of sealant
rate of sealant loss
Measured: one year
Secondary outcomes (1)
Caries incidence
rate of caries initiation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fathi Abdelsalam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779893
- Sponsor's protocol ID
- 14011989
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2018
- Last updated
- 15 Jan 2019
- 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 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03779893
- Acronym / sponsor ID
- 14011989
- Conditions
- Caries, Dental
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 Dec 2018 (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.
This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination \& VistaCAM.
Detailed description
In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.
With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Combination Product: 3M™ Clinpro™ Sealant.Conventional resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant is administrated |
| bioactive group | Experimental | Combination Product: BioCoat® by Premier®.Bioactive Pits \& fissures sealant BioCoat® by Premier®. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
- 19 - 40 years.
- Males or Females.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (10 listed)
- Patients younger than 19 years old or older than 40 years old.
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Allergic history concerning methacrylate.
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 |
|---|---|---|
| BioCoat® by Premier®.Bioactive pits and fissure sealant | Combination product | bioactive group |
| 3M™ Clinpro™ Sealant.conventional pits and fissure sealant | Combination product | conventional group |
Primary outcome
Retention of sealant
Time frame: one year
rate of sealant loss
1 secondary outcome
Caries incidence
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BioCoat® by Premier®. and 3M™ Clinpro™ Sealant. in people with Caries, Dental, 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 10 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 15 Jan 2019. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Retention of sealant (time frame: one 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 15 Jan 2019.