CariesNCT05127343
Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants
A study testing Sealing deep pits and fissures in people with Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Sealing deep pits and fissures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2022to Feb 2023
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
- Cooperative patients who will allow the clinical applications
Who cannot join
- Uncooperative behaviour limiting the use of sealants throughout the procedure.
- Patients with history of medical diseases, drug therapies or any other serious relevant problem.
- Patients with well coalesced pits and fissures
- Patients allergic to sealant material
- Patients who underwent orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Heba Helal, Post Phd contact
Egypt1 site
Faculty of dentistry
Cairo, 11331
Iman I ElSayad, Professor, 0201005287368, iman.sayad@dentistry.cu.edu.eg
About this study
Official title: One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.
- Conditions
- Caries
- Being tested
- Sealing deep pits and fissures
- Keywords
- Pit and fissure sealant, Retention rate, Caries formation, Hydrophilic sealant
- 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.
Sealing deep pits and fissuresProcedure or surgery
Application of the pit and fissure sealant
| Study group | Role | What they receive |
|---|---|---|
| Resin based sealant (Ultraseal XT Hydro) | Active comparator | Not described Receives: Procedure: Sealing deep pits and fissures |
| Glass ionomer based sealant (Fugi Triage) | Active comparator | Not described Receives: Procedure: Sealing deep pits and fissures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
- Full retention (FR): The material is fully present on the occlusal surfaces
- Partially lost (PL): The material is present, but as a result of either wear or loss of the material, part of the previously sealed fissure, was exposed.
- Totally lost (TL): No trace of the material to be detected on the surface
Measured: Change from baseline at 3, 6, 12 months
Secondary outcomes (1)
Caries formation
Decayed: If the explorer caught on the tooth after insertion into the fissures
Measured: Change from baseline at 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study startFeb 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohamed El-Amir Hashim Sediek, Cairo University
- Investigators
- Iman I ElSayad, Professor, Study director, Cairo UniversityHeba Helal, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127343
- Sponsor's protocol ID
- CU-2021
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05127343
- Acronym / sponsor ID
- CU-2021
- Conditions
- Caries
- Keywords
- Pit and fissure sealant, Retention rate, Caries formation, Hydrophilic sealant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 19 Nov 2021 (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 clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin based sealant (Ultraseal XT Hydro) | Active comparator | Procedure: Sealing deep pits and fissures |
| Glass ionomer based sealant (Fugi Triage) | Active comparator | Procedure: Sealing deep pits and fissures |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
- Cooperative patients who will allow the clinical applications
Key exclusion criteria (5 listed)
- Uncooperative behaviour limiting the use of sealants throughout the procedure.
- Patients with history of medical diseases, drug therapies or any other serious relevant problem.
- Patients with well coalesced pits and fissures
- Patients allergic to sealant material
- Patients who underwent orthodontic treatment.
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 |
|---|---|---|
| Sealing deep pits and fissuresApplication of the pit and fissure sealant | Procedure or surgery | Glass ionomer based sealant (Fugi Triage), Resin based sealant (Ultraseal XT Hydro) |
Primary outcome
Retention rate
Time frame: Change from baseline at 3, 6, 12 months
* Full retention (FR): The material is fully present on the occlusal surfaces * Partially lost (PL): The material is present, but as a result of either wear or loss of the material, part of the previously sealed fissure, was exposed. * Totally lost (TL): No trace of the material to be detected on the surface
1 secondary outcome
Caries formation
Time frame: Change from baseline at 3, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Heba Helal, Post Phd contact
Iman I ElSayad, Professor study director
Cairo University
Heba Helal study director
Cairo 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 Sealing deep pits and fissures in people with Caries, run by Cairo University 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 3 inclusion and 5 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 19 Nov 2021. 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?
Contact Iman I ElSayad, Professor (0201005287368, iman.sayad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention rate (time frame: Change from baseline at 3, 6, 12 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 19 Nov 2021.