Caries PreventionNCT04272866
Comparing Bond Strength,Microleakage and Clinical Performance of Three Pit and Fissure Sealants
A study testing Clinpro sealant, Embrace wetbond sealant and Triage sealant in people with Caries Prevention, run by Sarah Emad Ali El-Din at 1 site in Egypt.
Trial summary
The aim of the study is :- 1. To evaluate and compare the microleakage of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro. 2. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Prevention
- What is being tested?
- Clinpro sealant, Embrace wetbond sealant and Triage sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2019to Mar 2020
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1- First permanent molars fully erupted with deep and retentive fissures,free of caries and free of any periapical radiolucency.
- 2- Males and Females 3- Age group between 6-9 years 4- Medically free 5- High caries risk children
Who cannot join
- Medically compromised children
- Uncooperative children.
- Children with abnormalities in occlusion
- children with abnormal oral habits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Bond Strength,Microleakage and the Clinical Performance of Three Different Pit and Fissure Sealants (An in Vitro,in Vivo Study)
The aim of the study is :-
- To evaluate and compare the microleakage of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
- To evaluate and compare the bond strength of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
- To clinically evaluate and compare the retention of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).
- To clinically evaluate and compare the caries prevention effect of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).
Read the detailed description
Total of 60 first permanent molar in male and female children aged between 6-9 years included in this prospective study will be selected randomly from the outpatient Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Ain Shams University.
Informed consent will be signed for each case by the patient's parent or guardian after thorough explanation of the study.
Procedural Steps:
In vivo
- Teeth will be divided equally into 3 groups randomly according to the type of sealant used.
- Pit and fissure sealant application will be conducted by a single operator.
- A thorough oral prophylaxis of both upper and lower arches was done, followed by polishing using a slurry of pumice and rotating brush to ensure removal of debris from fissures.
- The occlusal surfaces were then thoroughly cleaned with water to remove all traces of pumice. Isolation of permanent first molars will be obtained using cotton rolls and a saliva ejector.
Group 1(Clinpro sealant)Active control
- The occlusal surface will be dried and etched with 37% phosphoric acid gel for 30 s
- Thorough rinsing for 30 s using an oil-free air-water syringe.
- Clinpro™ Sealant then applied with the brush applicator and light cured for 20 s using visible light cure unit.
Group 2(Embrace WetBond sealant)
- Etching the teeth for 15 seconds with a phosphoric-acid etchant.
- Then rinse the etchant from the teeth with an air-water spray for 10 seconds,
- followed by very light drying of the treated surfaces. With Embrace Wet-Bond, the typical dull, frosted appearance of the etched surface is not desired. Rather, the surface should be lightly dried and very slightly moist with a glossy appearance. To accomplish this, a cotton pellet should be used to remove the excess moisture There should be no visible pooling or drops of water on the tooth surfaces.
- Applying the Embrace WetBond sealant to the occlusal surface using the supplied applicator tip After dispensing, use a brush applicator to place the sealant, covering all pits and fissures and extending onto the cusp ridges. The final sealant thickness upon application should be at least 0.3 mm.
- After application, light-cure the sealant for 10 seconds, holding the light-curing probe at right angles to the occlusal surface as close as possible using a high-intensity curing light.
Group 3 (Fuji Triage sealant)
- The occlusal surfaces conditioned with Dentin Conditioner for 20 s and then rinsed for another 20 s, followed by drying by blotting with a cotton pellet and gently blowing with an air syringe. The surfaces appeared moist and not desiccated.
- Fuji Triage sealant will then applied to the occlusal surface using a plastic-filling instrument and a disposable nylon brush to spread it into the pits and fissures.
- The material is self-curing, but a light-curing device can be used for 20 to 40 seconds to hasten setting.
- When the material loses its glossy appearance, one drop of Fuji Coat is dispensed The coating is applied with a brush to the treated surface and adjacent areas, and light curing is applied .
Articulating paper was used to check the occlusion and any premature contacts were adjusted. The patients were instructed not to eat or drink anything for 30 min, and not to bite or chew on hard substances for the rest of the day. The patients were recalled after a time interval of 1 and 6 months to evaluate the retention and development of caries using Modified Simonsen's criteria.
Criteria for evaluation: (Modified simonsen's criteria) Score 0: No loss of sealant and no evidence of caries Score 1: Partial loss of sealant and no evidence of caries Score 2: Partial loss of sealant and evidence of caries. Score 3: Complete loss of sealant and no evidence of caries Score 4: Complete loss of sealant and evidence of caries. On recall at 3 and 6th month interval, the sealants were evaluated by visual and tactile examination with a sharp probe for retention. The teeth were visually inspected for caries. The data obtained were tabulated and subjected to statistical analysis.
- Conditions
- Caries Prevention
- Being tested
- Clinpro sealant, Embrace wetbond sealant, Triage sealant
- Keywords
- Caries prevention, Pit and fissure sealant, Clinpro, Triage, Embrace
- 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.
Clinpro sealantOther
Resin based sealant
Embrace wetbond sealantOther
Moisture tolerant hydrophilic resin based sealant
Triage sealantOther
Glass ionomer sealant
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Teeth in this group will be sealed with clinpro sealant Receives: Other: Clinpro sealant |
| Group2 | Experimental | Teeth in this group will be sealed with embrace wetbond sealant Receives: Other: Embrace wetbond sealant |
| Group3 | Experimental | Teeth in this group will be sealed with triage sealant Receives: Other: Triage sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the sealants
Retention of the sealants will be evaluated according to modified Simon's criteria
Measured: 6 months
Caries prevention effect of the sealants
Caries prevention effects will be evaluated according to modified Simon's criteria
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start3 Jul 2019
- Primary completionMar 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 PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Emad Ali El-Din
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Emad Ali El-Din, Ain Shams University
- Investigators
- Sarah E Alieldin, Principal investigator, Faculty of dentistry ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272866
- Sponsor's protocol ID
- PED 18-9M
- Status last verified
- Feb 2020
- First submitted
- 1 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Bond Strength,Microleakage and the Clinical Performance of Three Different Pit and Fissure Sealants (An in Vitro,in Vivo Study)
- ClinicalTrials.gov ID
- NCT04272866
- Acronym / sponsor ID
- PED 18-9M
- Conditions
- Caries Prevention
- Keywords
- Caries prevention, Pit and fissure sealant, Clinpro, Triage, Embrace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sarah Emad Ali El-DinUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 17 Feb 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.
The aim of the study is :-
- To evaluate and compare the microleakage of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
- To evaluate and compare the bond strength of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
- To clinically evaluate and compare the retention of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).
- To clinically evaluate and compare the caries prevention effect of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).
Detailed description
Total of 60 first permanent molar in male and female children aged between 6-9 years included in this prospective study will be selected randomly from the outpatient Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Ain Shams University.
Informed consent will be signed for each case by the patient's parent or guardian after thorough explanation of the study.
Procedural Steps:
In vivo
- Teeth will be divided equally into 3 groups randomly according to the type of sealant used.
- Pit and fissure sealant application will be conducted by a single operator.
- A thorough oral prophylaxis of both upper and lower arches was done, followed by polishing using a slurry of pumice and rotating brush to ensure removal of debris from fissures.
- The occlusal surfaces were then thoroughly cleaned with water to remove all traces of pumice. Isolation of permanent first molars will be obtained using cotton rolls and a saliva ejector.
Group 1(Clinpro sealant)Active control
- The occlusal surface will be dried and etched with 37% phosphoric acid gel for 30 s
- Thorough rinsing for 30 s using an oil-free air-water syringe.
- Clinpro™ Sealant then applied with the brush applicator and light cured for 20 s using visible light cure unit.
Group 2(Embrace WetBond sealant)
- Etching the teeth for 15 seconds with a phosphoric-acid etchant.
- Then rinse the etchant from the teeth with an air-water spray for 10 seconds,
- followed by very light drying of the treated surfaces. With Embrace Wet-Bond, the typical dull, frosted appearance of the etched surface is not desired. Rather, the surface should be lightly dried and very slightly moist with a glossy appearance. To accomplish this, a cotton pellet should be used to remove the excess moisture There should be no visible pooling or drops of water on the tooth surfaces.
- Applying the Embrace WetBond sealant to the occlusal surface using the supplied applicator tip After dispensing, use a brush applicator to place the sealant, covering all pits and fissures and extending onto the cusp ridges. The final sealant thickness upon application should be at least 0.3 mm.
- After application, light-cure the sealant for 10 seconds, holding the light-curing probe at right angles to the occlusal surface as close as possible using a high-intensity curing light.
Group 3 (Fuji Triage sealant)
- The occlusal surfaces conditioned with Dentin Conditioner for 20 s and then rinsed for another 20 s, followed by drying by blotting with a cotton pellet and gently blowing with an air syringe. The surfaces appeared moist and not desiccated.
- Fuji Triage sealant will then applied to the occlusal surface using a plastic-filling instrument and a disposable nylon brush to spread it into the pits and fissures.
- The material is self-curing, but a light-curing device can be used for 20 to 40 seconds to hasten setting.
- When the material loses its glossy appearance, one drop of Fuji Coat is dispensed The coating is applied with a brush to the treated surface and adjacent areas, and light curing is applied .
Articulating paper was used to check the occlusion and any premature contacts were adjusted. The patients were instructed not to eat or drink anything for 30 min, and not to bite or chew on hard substances for the rest of the day. The patients were recalled after a time interval of 1 and 6 months to evaluate the retention and development of caries using Modified Simonsen's criteria.
Criteria for evaluation: (Modified simonsen's criteria) Score 0: No loss of sealant and no evidence of caries Score 1: Partial loss of sealant and no evidence of caries Score 2: Partial loss of sealant and evidence of caries. Score 3: Complete loss of sealant and no evidence of caries Score 4: Complete loss of sealant and evidence of caries. On recall at 3 and 6th month interval, the sealants were evaluated by visual and tactile examination with a sharp probe for retention. The teeth were visually inspected for caries. The data obtained were tabulated and subjected to statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Clinpro sealantTeeth in this group will be sealed with clinpro sealant |
| Group2 | Experimental | Other: Embrace wetbond sealantTeeth in this group will be sealed with embrace wetbond sealant |
| Group3 | Experimental | Other: Triage sealantTeeth in this group will be sealed with triage sealant |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1- First permanent molars fully erupted with deep and retentive fissures,free of caries and free of any periapical radiolucency.
- 2- Males and Females 3- Age group between 6-9 years 4- Medically free 5- High caries risk children
Key exclusion criteria (4 listed)
- Medically compromised children
- Uncooperative children.
- Children with abnormalities in occlusion
- children with abnormal oral 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 |
|---|---|---|
| Clinpro sealantResin based sealant | Other | Group 1 |
| Embrace wetbond sealantMoisture tolerant hydrophilic resin based sealant | Other | Group2 |
| Triage sealantGlass ionomer sealant | Other | Group3 |
Primary outcome
Retention of the sealants
Time frame: 6 months
Retention of the sealants will be evaluated according to modified Simon's criteria
Caries prevention effect of the sealants
Time frame: 6 months
Caries prevention effects will be evaluated according to modified Simon's criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Sarah E Alieldin principal investigator
Faculty of dentistry ain shams 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 Clinpro sealant, Embrace wetbond sealant and Triage sealant in people with Caries Prevention, run by Sarah Emad Ali El-Din 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 17 Feb 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?
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 the sealants (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 17 Feb 2020.