Dental CariesNCT06003452
Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults
A study testing surface treatment with Bioactive Glass Air Abrasion in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Prevention of oral diseases is preferable to treatment and is the key method of achieving cost effectiveness for oral health improvement programs. Various preventive strategies for dental caries have been tried and are still being developed. Read more about this study
- Who is it for?
- Ages 17 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- surface treatment with Bioactive Glass Air Abrasion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Apr 2025
- 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 17 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young adult Patients Aged 17-22.
- Good oral hygiene (plaque index score 0 or 1).
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Patients approving to participate in the study.
Who cannot join
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Prevention of oral diseases is preferable to treatment and is the key method of achieving cost effectiveness for oral health improvement programs. Various preventive strategies for dental caries have been tried and are still being developed. The occlusal pits and fissures of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure surfaces, which favours stagnation of bacteria and substrates. Fissure sealing has been shown to be an evidence-based caries preventive method for protecting the occlusal surfaces against caries. Non- sealed teeth need to be restored approximately 50% more frequently compared to their sealed counterpart. Sealants are effective caries preventive agents as long as they remain bonded to teeth.
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application.A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive.
Read the detailed description
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application. A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive3.
A new bioactive hybrid material (giomer) that combined the advantages of resin composites with glass ionomer cements has been introduced, it based on pre-reacted glass ionomer (PRG) filler technology in which fluoroaluminosilicate glass particles that have previously reacted with the polyacrylic acid were dispersed in resin. Giomer based pit and fissure sealant using self-etch primer eliminates phosphoric acid etch and rinse, thus conserving the enamel and reducing chair side time. However, retention of self-etch adhesive as compared to conventional sealants is questionable4.
A new method for sealant application using air- abrasive technology is less technique sensitive and allows for further cleaning of the grooves prior to sealant placement. The abrasive particles used in air abrasion effectively remove organic plug material from the grooves and allow for deeper penetration of the sealant material into the grooves5.
Aim of the study:
The aim of study is to evaluate retention rate and caries prevention of giomer based sealant with and without pre-treatment by bioactive glass air abrasion in young adults over one year
PICOTS:
(P) Patient/Population: Deep retentive fissures ( ICDAS 0,1,2) in second and third molars for 17-22 years old patients.
(I) Intervention: Giomer Based Sealant With Prior BioactiveGlass Air Abrasion. (C) Comparator: Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion.
(O) Outcome:
Prioritization of Outcome
Outcome Method of Measurement (with reference)
Unit of Measurement
- ry Outcome: Loss of retention Simonsen's criteria
- 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.
- ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha: Absence of the caries Charlie: Presence of the caries (T) Time :- T0 :- Baseline T1:- 3 months Study Design: Two parallel arms randomized clinical trial. Study Framework: Superiority framework
Hypothesis:
The null hypothesis tested in this study is that there will be no difference either in the retention rate or caries prevention of giomer based sealant with and without treatment by bioactive glass air abrasion in young adults
Research question:
In deep retentive fissures, Will the use of bioactive glass air abrasion particles improve the retention rate and caries prevention of the giomer based sealant?
Methodology :
In Group 1: the self-etch primer (BeautiSealant Primer, Shofu, Japan) will be applied to the occlusal fissures with a fine micro brush. After waiting for 5 s, gently air blow for about 3 sec and then dry with stronger stream of air until a thin and uniform bonding layer is obtained. The giomer sealant. In Group 2: occlusal surface will be subjected to 5s of bioglass (AquaCare- Velopex International) , then sealant (BeautiSealant Paste, Shofu, Japan) will be applied as aforementioned steps and light-cured for 20 s. In both groups, the surfaces were checked with an explorer to ensure that no voids were present. The occlusion was checked and, if necessary, adjusted.
- Conditions
- Dental Caries
- Being tested
- surface treatment with Bioactive Glass Air Abrasion
- Keywords
- Fissure sealant, Bio-active glass, caries prevention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface treatment with Bioactive Glass Air AbrasionProcedure or surgery
giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion
| Study group | Role | What they receive |
|---|---|---|
| Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion | Active comparator | giomer based fissure sealnt will be applied without surface treatment Receives: Procedure: surface treatment with Bioactive Glass Air Abrasion |
| Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion | Experimental | giomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion Receives: Procedure: surface treatment with Bioactive Glass Air Abrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of sealant's retention
Simonsen's criteria 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: 6 months
Secondary outcomes (1)
Secondary Caries
Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries
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 posted22 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yomna sayed khallaf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003452
- Sponsor's protocol ID
- Fissure sealnt
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2023
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khallaf YS, Hassanein OE, Adly AM, Kamal D. Clinical performance of a giomer-based pit and fissure sealant with and without air-abrasion pretreatment: a 12-month randomized clinical trial. BMC Oral Health. 2026 Sep 3;26(1):1662. doi: 10.1186/s12903-026-09691-8.
PubMed 42687162
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Rate And Caries Prevention Of Giomer Based Sealant With And Without Pre-Treatment With Bioactive Glass Air Abrasion In Young Adults
- ClinicalTrials.gov ID
- NCT06003452
- Acronym / sponsor ID
- Fissure sealnt
- Conditions
- Dental Caries
- Keywords
- Fissure sealant, Bio-active glass, caries prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 22 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.
Prevention of oral diseases is preferable to treatment and is the key method of achieving cost effectiveness for oral health improvement programs. Various preventive strategies for dental caries have been tried and are still being developed. The occlusal pits and fissures of posterior teeth are highly susceptible to caries because of the anatomy of pit and fissure surfaces, which favours stagnation of bacteria and substrates. Fissure sealing has been shown to be an evidence-based caries preventive method for protecting the occlusal surfaces against caries. Non- sealed teeth need to be restored approximately 50% more frequently compared to their sealed counterpart. Sealants are effective caries preventive agents as long as they remain bonded to teeth.
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application.A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive.
Detailed description
It has been proposed that sealants should be placed on both sound teeth and incipient non-cavitated carious lesions on permanent teeth of high caries risk patients in order to prevent the onset of caries and its progression. According to the American Dental Association Guidelines for the use of pit and fissure sealants, ICDAS II codes 0, 1 and 2 are recommended for sealant application. A variety of dental materials have been used as sealants using different application techniques. Their effectiveness depends on the formation of a complete seal and is increased by correct technique and moisture control, appropriate follow-up and resealing as necessary. Resin-based conventional sealants are preferred choice, however use of phosphoric acid demineralizes the enamel layer and have elongated treatment time and is more technique sensitive3.
A new bioactive hybrid material (giomer) that combined the advantages of resin composites with glass ionomer cements has been introduced, it based on pre-reacted glass ionomer (PRG) filler technology in which fluoroaluminosilicate glass particles that have previously reacted with the polyacrylic acid were dispersed in resin. Giomer based pit and fissure sealant using self-etch primer eliminates phosphoric acid etch and rinse, thus conserving the enamel and reducing chair side time. However, retention of self-etch adhesive as compared to conventional sealants is questionable4.
A new method for sealant application using air- abrasive technology is less technique sensitive and allows for further cleaning of the grooves prior to sealant placement. The abrasive particles used in air abrasion effectively remove organic plug material from the grooves and allow for deeper penetration of the sealant material into the grooves5.
Aim of the study:
The aim of study is to evaluate retention rate and caries prevention of giomer based sealant with and without pre-treatment by bioactive glass air abrasion in young adults over one year
PICOTS:
(P) Patient/Population: Deep retentive fissures ( ICDAS 0,1,2) in second and third molars for 17-22 years old patients.
(I) Intervention: Giomer Based Sealant With Prior BioactiveGlass Air Abrasion. (C) Comparator: Giomer Based Sealant Without Prior Bioactive Glass Air Abrasion.
(O) Outcome:
Prioritization of Outcome
Outcome Method of Measurement (with reference)
Unit of Measurement
- ry Outcome: Loss of retention Simonsen's criteria
- 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.
- ry Outcomes Secondary Caries Modified USPHS criteria7 Alpha: Absence of the caries Charlie: Presence of the caries (T) Time :- T0 :- Baseline T1:- 3 months Study Design: Two parallel arms randomized clinical trial. Study Framework: Superiority framework
Hypothesis:
The null hypothesis tested in this study is that there will be no difference either in the retention rate or caries prevention of giomer based sealant with and without treatment by bioactive glass air abrasion in young adults
Research question:
In deep retentive fissures, Will the use of bioactive glass air abrasion particles improve the retention rate and caries prevention of the giomer based sealant?
Methodology :
In Group 1: the self-etch primer (BeautiSealant Primer, Shofu, Japan) will be applied to the occlusal fissures with a fine micro brush. After waiting for 5 s, gently air blow for about 3 sec and then dry with stronger stream of air until a thin and uniform bonding layer is obtained. The giomer sealant. In Group 2: occlusal surface will be subjected to 5s of bioglass (AquaCare- Velopex International) , then sealant (BeautiSealant Paste, Shofu, Japan) will be applied as aforementioned steps and light-cured for 20 s. In both groups, the surfaces were checked with an explorer to ensure that no voids were present. The occlusion was checked and, if necessary, adjusted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion | Active comparator | Procedure: surface treatment with Bioactive Glass Air Abrasiongiomer based fissure sealnt will be applied without surface treatment |
| Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion | Experimental | Procedure: surface treatment with Bioactive Glass Air Abrasiongiomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion |
Who may qualify
- Ages
- 17 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Young adult Patients Aged 17-22.
- Good oral hygiene (plaque index score 0 or 1).
- Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
- Patients approving to participate in the study.
Key exclusion criteria (3 listed)
- Patients with known allergic or adverse reaction to the tested materials.
- Systematic disease that may affect participation.
- Xerostomic patients.
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 |
|---|---|---|
| surface treatment with Bioactive Glass Air Abrasiongiomer based fissure sealnt will be applied after surface treatment With Bioactive Glass Air Abrasion | Procedure or surgery | Giomer Based Sealant With Pre-Treatment With Bioactive Glass Air Abrasion, Giomer Based Sealant Without Pre-Treatment With Bioactive Glass Air Abrasion |
Primary outcome
Loss of sealant's retention
Time frame: 6 months
Simonsen's criteria 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.
1 secondary outcome
Secondary Caries
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 42687162Khallaf YS, Hassanein OE, Adly AM, Kamal D. Clinical performance of a giomer-based pit and fissure sealant with and without air-abrasion pretreatment: a 12-month randomized clinical trial. BMC Oral Health. 2026 Sep 3;26(1):1662. doi: 10.1186/s12903-026-09691-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surface treatment with Bioactive Glass Air Abrasion in people with Dental 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 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: finished, as of the sponsor's last update on 3 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Loss of sealant's retention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003452, which also lists 1 linked publication.
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 3 Feb 2026.