Pits and Fissures SealantNCT05988801
Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars
A study testing Glass ionomer sealant and Resin based sealant in people with Pits and Fissures Sealant, run by Cairo University.
Trial summary
evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pits and Fissures Sealant
- What is being tested?
- Glass ionomer sealant and Resin based sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Nov 2024
- 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
- • Children aged between 6 to 9 years
- Children with deeply stained fissures of the first permanent molars.
- First permanent molars are completely erupted
- The patient's willingness to receive treatment
Who cannot join
- • Special child, a child with compromised systemic health.
- First permanent molars covered by operculum.
- Children with high salivary flow when isolation will be impossible
Trial locations and contacts
No sites are listed yet.
Yasmin Mohamed Yousry, Lecturer contact
About this study
Official title: Clinical and Radiographic Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars: A Randomized Clinical Trial.
evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars
Read the detailed description
GIC has a hydrophilic nature which makes it compatible with clinical situations when isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture. Glass ionomers release fluoride, which promotes enamel remineralization and has an antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which is critical in the case of young patients and patients with disabilities.
- Conditions
- Pits and Fissures Sealant
- Being tested
- Glass ionomer sealant, Resin based sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass ionomer sealantOther
glass ionomer-based sealant material
Resin based sealantOther
resin-based sealant material
| Study group | Role | What they receive |
|---|---|---|
| Glass ionomer sealant | Experimental | glass ionomer based sealant material Receives: Other: Glass ionomer sealant |
| Resin sealant | Active comparator | resin-based sealant material Receives: Other: Resin based sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal discoloration
Marginal discoloration will be measured with visual examination and recorded in Alfa: Lack of discoloration, Bravo: Margin discoloration, and Charlie: Discoloration under the sealant.
Measured: 6 months
Secondary outcomes (2)
sealant retention
Sealant retention will be measured with a mouth mirror and probe and recorded in total retention or partial loss or complete loss
Measured: 6 months
Dental Caries
The absence or presence of any signs of dental caries or periapical infection will be measured with a periapical X-ray
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 posted14 Aug 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pits and Fissures SealantStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abrar Hossam Ahmed Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988801
- Sponsor's protocol ID
- Glass Ionomer VS Resin sealant
- Status last verified
- Aug 2023
- First submitted
- 13 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05988801
- Acronym / sponsor ID
- Glass Ionomer VS Resin sealant
- Conditions
- Pits and Fissures Sealant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars
Detailed description
GIC has a hydrophilic nature which makes it compatible with clinical situations when isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture. Glass ionomers release fluoride, which promotes enamel remineralization and has an antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which is critical in the case of young patients and patients with disabilities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glass ionomer sealant | Experimental | Other: Glass ionomer sealantglass ionomer based sealant material |
| Resin sealant | Active comparator | Other: Resin based sealantresin-based sealant material |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Children aged between 6 to 9 years
Key exclusion criteria (3 listed)
- • Special child, a child with compromised systemic health.
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 |
|---|---|---|
| Glass ionomer sealantglass ionomer-based sealant material | Other | Glass ionomer sealant |
| Resin based sealantresin-based sealant material | Other | Resin sealant |
Primary outcome
Marginal discoloration
Time frame: 6 months
Marginal discoloration will be measured with visual examination and recorded in Alfa: Lack of discoloration, Bravo: Margin discoloration, and Charlie: Discoloration under the sealant.
2 secondary outcomes
sealant retention
Time frame: 6 months
Dental Caries
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- 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.
Yasmin Mohamed Yousry, Lecturer contact
Questions about this trial
What is this clinical trial studying?
A study testing Glass ionomer sealant and Resin based sealant in people with Pits and Fissures Sealant, 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 3 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 14 Aug 2023. 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 Abrar Hossam Ahmed, Masters student (00201012979732, abrar.saleh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal discoloration (time frame: 6 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 14 Aug 2023.