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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Egypt1 site
  • Faculty of dentistry ain shams university

    Cairo

Other trials in Egypt

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 :-

  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. 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.
  3. 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).
  4. 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

  1. Teeth will be divided equally into 3 groups randomly according to the type of sealant used.
  2. Pit and fissure sealant application will be conducted by a single operator.
  3. 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.
  4. 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

  1. The occlusal surface will be dried and etched with 37% phosphoric acid gel for 30 s
  2. Thorough rinsing for 30 s using an oil-free air-water syringe.
  3. Clinpro™ Sealant then applied with the brush applicator and light cured for 20 s using visible light cure unit.

Group 2(Embrace WetBond sealant)

  1. Etching the teeth for 15 seconds with a phosphoric-acid etchant.
  2. Then rinse the etchant from the teeth with an air-water spray for 10 seconds,
  3. 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.
  4. 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.
  5. 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)

  1. 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.
  2. 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.
  3. The material is self-curing, but a light-curing device can be used for 20 to 40 seconds to hasten setting.
  4. 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.

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 groups in NCT04272866
Study groupRoleWhat they receive
Group 1Active comparatorTeeth in this group will be sealed with clinpro sealant
Receives: Other: Clinpro sealant
Group2ExperimentalTeeth in this group will be sealed with embrace wetbond sealant
Receives: Other: Embrace wetbond sealant
Group3ExperimentalTeeth 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.

  1. Retention of the sealants

    Retention of the sealants will be evaluated according to modified Simon's criteria

    Measured: 6 months

  2. 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.

  1. First posted17 Feb 2020
  2. Study start3 Jul 2019
  3. Primary completionMar 2020 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

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)
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

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.

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