Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to CariesNCT04560985
Evaluation of Retention for Hydrophilic and Hydrophobic Sealants in Uncooperative Children
A study testing Hydrophilic fissure sealant and Hydrophobic fissure sealant in people with Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries, run by King Abdulaziz University.
Trial summary
To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries
- What is being tested?
- Hydrophilic fissure sealant and Hydrophobic fissure sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Jan 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 with good health and without any systematic diseases history which may interfere with their oral hygiene.
- Children ranging in age from 6 to 9 years.
- Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II).
- Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale.
- Informed consent to the child's participation in the study signed by one of his/her parents/guardian.
- No children will be excluded on the basis of gender, race, social or economic status
Who cannot join
- Children with systemic diseases.
- Children with oral habits affecting occlusion.
- Children with any physical or mental disorders.
- Children with cavitated, defected, missed or restored contralateral tooth.
- Children with history of allergy to resin or latex.
- Teeth with restorations, cavitated lesion, hypoplasia and any developmental defects.
- Not approving to sign the consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial
To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children.
- Being tested
- Hydrophilic fissure sealant, Hydrophobic fissure sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrophilic fissure sealantOther
Hydrophilic fissure sealant on first molars
Hydrophobic fissure sealantOther
Hydrophobic fissure sealant on first molars
| Study group | Role | What they receive |
|---|---|---|
| Hydrophilic sealant | Experimental | UltraSeal XT hydro™ sealant ® Receives: Other: Hydrophilic fissure sealant |
| Hydrophobic sealant | Active comparator | Helioseal-F Sealant ® Receives: Other: Hydrophobic fissure sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Measured: At 3 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Measured: At 6 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Measured: At 12 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Measured: At 18 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Measured: At 24 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Measured: At 36 months
Secondary outcomes (6)
Caries scoring using Color, Coverage and Caries (CCC) system
Measured: At 3 months
Caries scoring using Color, Coverage and Caries (CCC) system
Measured: At 6 months
Caries scoring using Color, Coverage and Caries (CCC) system
Measured: At 12 months
Caries scoring using Color, Coverage and Caries (CCC) system
Measured: At 18 months
Caries scoring using Color, Coverage and Caries (CCC) system
Measured: At 24 months
Caries scoring using Color, Coverage and Caries (CCC) system
Measured: At 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to CariesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein A. Alharthy, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560985
- Sponsor's protocol ID
- 29-04-20
- Status last verified
- Sep 2020
- First submitted
- 5 Sep 2020
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Retention for Hydrophilic and Hydrophobic Resin-Based Sealants in Uncooperative Children: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04560985
- Acronym / sponsor ID
- 29-04-20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 23 Sep 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.
To evaluate and compare the retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants for sealing pits and fissures of permanent molars in uncooperative children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrophilic sealant | Experimental | Other: Hydrophilic fissure sealantUltraSeal XT hydro™ sealant ® |
| Hydrophobic sealant | Active comparator | Other: Hydrophobic fissure sealantHelioseal-F Sealant ® |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children with good health and without any systematic diseases history which may interfere with their oral hygiene.
- Children ranging in age from 6 to 9 years.
- Children with bilateral fully erupted mandibular first permanent molars with deep fissures having a score of 0 following the International Caries Detection and Assessment System II (ICDAS II).
- Uncooperative children with "definitely negative" or "negative" behavioral ratings according to the Frankl behavior classification scale.
- Informed consent to the child's participation in the study signed by one of his/her parents/guardian.
Key exclusion criteria (7 listed)
- Children with systemic diseases.
- Children with oral habits affecting occlusion.
- Children with any physical or mental disorders.
- Children with cavitated, defected, missed or restored contralateral tooth.
- Children with history of allergy to resin or latex.
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 |
|---|---|---|
| Hydrophilic fissure sealantHydrophilic fissure sealant on first molars | Other | Hydrophilic sealant |
| Hydrophobic fissure sealantHydrophobic fissure sealant on first molars | Other | Hydrophobic sealant |
Primary outcome
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Time frame: At 3 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Time frame: At 6 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Time frame: At 12 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Time frame: At 18 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Time frame: At 24 months
Sealant retention scoring using Color, Coverage and Caries (CCC) system
Time frame: At 36 months
6 secondary outcomes
Caries scoring using Color, Coverage and Caries (CCC) system
Time frame: At 3 months
Caries scoring using Color, Coverage and Caries (CCC) system
Time frame: At 6 months
Caries scoring using Color, Coverage and Caries (CCC) system
Time frame: At 12 months
Caries scoring using Color, Coverage and Caries (CCC) system
Time frame: At 18 months
Caries scoring using Color, Coverage and Caries (CCC) system
Time frame: At 24 months
Caries scoring using Color, Coverage and Caries (CCC) system
Time frame: At 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No
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 Hydrophilic fissure sealant and Hydrophobic fissure sealant in people with Sound Newly Erupted First Permanent Molars With Deep Fissures Susceptible to Caries, run by King Abdulaziz 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 6 inclusion and 7 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 23 Sep 2020. 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 Hussein Alharthy (+966 50 038 2288, dr.hussein30@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealant retention scoring using Color, Coverage and Caries (CCC) system (time frame: At 3 months). The study lists 6 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 23 Sep 2020.