Caries; InitialNCT04929327
Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting
A study testing Self etch Pit and fissure sealant application (prevent seal), Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting and Total etch resin based sealant ultraseal xt in people with Caries; Initial and Pit and Fissure Caries, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to clinically assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Initial, Pit and Fissure Caries
- What is being tested?
- Self etch Pit and fissure sealant application (prevent seal), Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting and Total etch resin based sealant ultraseal xt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2021to Dec 2021
- 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).
Who cannot join
- An individual with no previous caries experience and well coalesced pits and fissures.
- Partially erupted teeth.
- Teeth with cavitation or caries of the dentin.
- Teeth with dental fluorosis, Hypocalcification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting Versus Total Etch Resin Based Sealant in High Caries Risk Patients After One Year Follow up
The aim of the study is to clinically assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up.
- Conditions
- Caries; Initial, Pit and Fissure Caries
- Being tested
- Self etch Pit and fissure sealant application (prevent seal), Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting, Total etch resin based sealant ultraseal xt
- Keywords
- Pit and fissure sealant, Sandblasting, Air abrasion, Retention rate
- 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.
Self etch Pit and fissure sealant application (prevent seal)Procedure or surgery
Sealing deep pits and fissures
Self etch Pit and fissure sealant application (prevent seal) with prior sandblastingProcedure or surgery
Sandblasting before Sealing deep pits and fissures
Total etch resin based sealant ultraseal xtProcedure or surgery
Sealing deep pits and fissures
| Study group | Role | What they receive |
|---|---|---|
| Self-etch resin based sealant | Active comparator | Self-etch resin based sealant (prevent seal) without prior sandblasting. Receives: Procedure: Self etch Pit and fissure sealant application (prevent seal) |
| Prior Sandblasting | Active comparator | Self-etch resin based sealant prevent seal) with prior sandblasting. Receives: Procedure: Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting |
| Total-etch resin based sealant | Active comparator | Total-etch resin based sealant (ultraseal XT) (Ultradent Pro. Inc., USA) Receives: Procedure: Total etch resin based sealant ultraseal xt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate
•Full retention (FR): the material was fully present on the occlusal surfaces •Partially lost (PL): the material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. •Totally lost (TL): no trace of the material was detected on the surface.
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 posted18 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; InitialStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Hussien Abbass Zein El-Abdeen Ebeady, Cairo University
- Investigators
- Rawda Hesham H. Abd ElAziz, Post Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929327
- Sponsor's protocol ID
- CU-5-2021
- Status last verified
- Jun 2021
- First submitted
- 30 May 2021
- Last updated
- 18 Jun 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting Versus Total Etch Resin Based Sealant in High Caries Risk Patients After One Year Follow up
- ClinicalTrials.gov ID
- NCT04929327
- Acronym / sponsor ID
- CU-5-2021
- Conditions
- Caries; Initial, Pit and Fissure Caries
- Keywords
- Pit and fissure sealant, Sandblasting, Air abrasion, Retention rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jun 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 assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-etch resin based sealant | Active comparator | Procedure: Self etch Pit and fissure sealant application (prevent seal)Self-etch resin based sealant (prevent seal) without prior sandblasting. |
| Prior Sandblasting | Active comparator | Procedure: Self etch Pit and fissure sealant application (prevent seal) with prior sandblastingSelf-etch resin based sealant prevent seal) with prior sandblasting. |
| Total-etch resin based sealant | Active comparator | Procedure: Total etch resin based sealant ultraseal xtTotal-etch resin based sealant (ultraseal XT) (Ultradent Pro. Inc., USA) |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).
Key exclusion criteria (4 listed)
- An individual with no previous caries experience and well coalesced pits and fissures.
- Partially erupted teeth.
- Teeth with dental fluorosis, Hypocalcification
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 |
|---|---|---|
| Self etch Pit and fissure sealant application (prevent seal)Sealing deep pits and fissures | Procedure or surgery | Self-etch resin based sealant |
| Self etch Pit and fissure sealant application (prevent seal) with prior sandblastingSandblasting before Sealing deep pits and fissures | Procedure or surgery | Prior Sandblasting |
| Total etch resin based sealant ultraseal xtSealing deep pits and fissures | Procedure or surgery | Total-etch resin based sealant |
Primary outcome
Retention rate
Time frame: Change from baseline at 3, 6, 12 months
•Full retention (FR): the material was fully present on the occlusal surfaces •Partially lost (PL): the material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. •Totally lost (TL): no trace of the material was detected on the surface.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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.
Rawda Hesham H. Abd ElAziz, Post Phd 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 Self etch Pit and fissure sealant application (prevent seal), Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting and Total etch resin based sealant ultraseal xt in people with Caries; Initial and Pit and Fissure 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 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 18 Jun 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 Rawda Hesham H Abd ElAziz, Post Phd (01001097200, rawda.hesham@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 18 Jun 2021.