Pit and Fissure CariesNCT03628729
Investigation of the Incidence of Caries in Pits and Fissures Sealed With Bioactive Sealant Compared to Fluoride Releasing Resin Based Pit and Fissure Sealant
A study testing Embrace™ WetBond™ Pit & Fissure Sealant and Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA in people with Pit and Fissure Caries, run by Cairo University.
Trial summary
This study will be conducted to investigate the incidence of caries in pits and fissures sealed with a bioactive sealant compared to a fluoride releasing resin based pits and fissures sealant in preventive treatment procedures in adult population over a six months period. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Caries
- What is being tested?
- Embrace™ WetBond™ Pit & Fissure Sealant and Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jan 2019
- 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients should be 16-25 Years old
- Patient should have good oral hygiene and general health with at least 2 •sound intact occlusal surfaces of first and/or second molar teeth in each quadrant of maxilla or mandible.
Who cannot join
- Known allergy to any of the resins used
- Clinically detectable caries
- Previously placed sealants or restorations
- Bruxism or malocclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Incidence of Caries in Pits and Fissures Sealed With Bioactive Sealant
This study will be conducted to investigate the incidence of caries in pits and fissures sealed with a bioactive sealant compared to a fluoride releasing resin based pits and fissures sealant in preventive treatment procedures in adult population over a six months period.
Read the detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Tarek Heiba. The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 40 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be randomly divided into two groups according to type of sealant (S) where in group S1, pits and fissures will be sealed with bioactive pits-and-fissure sealant; while group S2, pits and fissures will be sealed with fluoride releasing resin based pits and fissures sealant. Each restoration will be assessed after three, six months,The tooth will be illuminated with a violet light approximately 405 nm thus stimulating both prophyrins to emit red light that contains less energy. the denser the bacteria colonization on tooth's surface, the more intense the red fluorescent signal; in contrast sound enamel sent out a green fluorescent signal. These light signals are recorded by the highly developed optics and analyzed by the device's software. The software filters and quantifies the fluorescence emitted by the dental tissue and converts the relationship between green and red.
- Conditions
- Pit and Fissure Caries
- Being tested
- Embrace™ WetBond™ Pit & Fissure Sealant, Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embrace™ WetBond™ Pit & Fissure SealantOther
pit and fissure sealant that contain the precursor in the formation of hydroxyapatite which is Amorphous Calcium Phosphate (ACP) ,which has anti-cariogenic effect as well as remineralization potential as it contain bioactive material which stimulate crystal growth within the lesion by increasing the concentration of calcium and phosphate ions
Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USAOther
Fluoride releasing resin based pits and fissures sealant
| Study group | Role | What they receive |
|---|---|---|
| Embrace™ WetBond™ Pit & Fissure Sealant. | Experimental | pits and fissures will be sealed with bioactive pits-and-fissure sealant Receives: Other: Embrace™ WetBond™ Pit & Fissure Sealant |
| Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA | Active comparator | Pits and fissures will be sealed by fluoride releasing resin based pits and fissures sealant Receives: Other: Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries incidence
development of pit and fissure caries
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pit and Fissure CariesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 40 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be randomly divided into two groups according to type of sealant (S) where in group S1, pits and fissures will be sealed with bioactive pits-and-fissure sealant; while group S2, pits and fissures will be sealed with fluoride releasing resin based pits and fissures sealant. Each restoration will be assessed after three, six months.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed tarek heiba, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628729
- Sponsor's protocol ID
- CEBD-CU-2018-07-17
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Incidence of Caries in Pits and Fissures Sealed With Bioactive Sealant
- ClinicalTrials.gov ID
- NCT03628729
- Acronym / sponsor ID
- CEBD-CU-2018-07-17
- Conditions
- Pit and Fissure Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 14 Aug 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 investigate the incidence of caries in pits and fissures sealed with a bioactive sealant compared to a fluoride releasing resin based pits and fissures sealant in preventive treatment procedures in adult population over a six months period.
Detailed description
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Tarek Heiba. The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 40 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be randomly divided into two groups according to type of sealant (S) where in group S1, pits and fissures will be sealed with bioactive pits-and-fissure sealant; while group S2, pits and fissures will be sealed with fluoride releasing resin based pits and fissures sealant. Each restoration will be assessed after three, six months,The tooth will be illuminated with a violet light approximately 405 nm thus stimulating both prophyrins to emit red light that contains less energy. the denser the bacteria colonization on tooth's surface, the more intense the red fluorescent signal; in contrast sound enamel sent out a green fluorescent signal. These light signals are recorded by the highly developed optics and analyzed by the device's software. The software filters and quantifies the fluorescence emitted by the dental tissue and converts the relationship between green and red.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 40 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be randomly divided into two groups according to type of sealant (S) where in group S1, pits and fissures will be sealed with bioactive pits-and-fissure sealant; while group S2, pits and fissures will be sealed with fluoride releasing resin based pits and fissures sealant. Each restoration will be assessed after three, six months.
| Arm | Type | Receives |
|---|---|---|
| Embrace™ WetBond™ Pit & Fissure Sealant. | Experimental | Other: Embrace™ WetBond™ Pit & Fissure Sealantpits and fissures will be sealed with bioactive pits-and-fissure sealant |
| Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA | Active comparator | Other: Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USAPits and fissures will be sealed by fluoride releasing resin based pits and fissures sealant |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients should be 16-25 Years old
- Patient should have good oral hygiene and general health with at least 2 •sound intact occlusal surfaces of first and/or second molar teeth in each quadrant of maxilla or mandible.
Key exclusion criteria (4 listed)
- Known allergy to any of the resins used
- Clinically detectable caries
- Previously placed sealants or restorations
- Bruxism or malocclusion
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 |
|---|---|---|
| Embrace™ WetBond™ Pit & Fissure Sealantpit and fissure sealant that contain the precursor in the formation of hydroxyapatite which is Amorphous Calcium Phosphate (ACP) ,which has anti-cariogenic effect as well as remineralization potential as it contain bioactive material which stimulate crystal growth within the lesion by increasing the concentration of calcium and phosphate ions | Other | Embrace™ WetBond™ Pit & Fissure Sealant. |
| Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USAFluoride releasing resin based pits and fissures sealant | Other | Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA |
Primary outcome
caries incidence
Time frame: six months
development of pit and fissure caries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Pit and Fissure Caries
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Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
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Evaluation of the Clinical Success of Hydrophilic Fissure Sealants
Pit and Fissure Caries (Disorder), Pit and Fissure Sealants
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Comparison of the Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Schoolchildren
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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 Embrace™ WetBond™ Pit & Fissure Sealant and Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA in people with Pit and Fissure Caries, 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 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 16 Aug 2018. 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 mohamed heiba (01000568165, m.tarek.heiba@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caries incidence (time frame: six 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 16 Aug 2018.