Dental CariesNCT07612540
Retention and Caries Prevention of Giomer Sealant With or Without Diode Laser Pre-treatment: A Randomized Controlled Trial
A study testing phosphoric acid pretreatment in people with Dental Caries, run by Cairo University at 3 sites in Egypt.
Trial summary
This randomized controlled trial evaluates the effect of diode laser pre-treatment on the retention and caries prevention of giomer-based fissure sealants in young adults aged 17-22 years. 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?
- phosphoric acid pretreatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites
Faculty of Dentistry Cairo University
Cairo
Faculty of Dentistry
Cairo
Yomna
Cairo
About this study
Official title: Retention Rate and Caries Prevention of Giomer Based Sealant With and Without Diode Laser Pre-treatment in Young Adults: A Randomized Controlled Trial
This randomized controlled trial evaluates the effect of diode laser pre-treatment on the retention and caries prevention of giomer-based fissure sealants in young adults aged 17-22 years. The study compares sealant application with and without diode laser conditioning on molars with ICDAS 0-2 fissures over a 12-month follow-up period. Primary outcome is sealant retention using Simonsen's criteria, while secondary outcome is caries prevention using modified USPHS criteria. The study hypothesizes that diode laser pre-treatment may improve sealant retention and enhance caries prevention by modifying enamel surface characteristics and improving sealant penetration.
Read the detailed description
The protocol investigates whether diode laser pre-treatment can improve the clinical performance of a giomer-based fissure sealant in young adults. The study is designed as a two-arm randomized controlled clinical trial evaluating sealant retention and caries prevention over a 12-month period.
The background emphasizes that pits and fissures of posterior teeth are highly susceptible to caries, and fissure sealants are an evidence-based preventive approach. Giomer sealants combine the advantages of resin composites and glass ionomer materials through S-PRG filler technology, offering fluoride release and simplified application using self-etch primer systems. However, concerns remain regarding their long-term retention. Diode laser enamel pre-treatment is proposed to enhance enamel surface roughness, improve sealant penetration, and increase resistance to acid dissolution, potentially improving retention and caries prevention.
The study aims to compare giomer-based sealant application with and without diode laser pre-treatment in patients aged 17-22 years having deep retentive fissures with ICDAS scores 0-2 in second and third molars. Primary outcome is sealant retention assessed using Simonsen's criteria, while secondary outcome is caries prevention evaluated using modified USPHS criteria at baseline, 6 months, and 12 months.
The null hypothesis states that diode laser pre-treatment will not significantly affect retention rate or caries prevention compared with conventional application. The protocol includes detailed sample size calculation based on previous literature, resulting in 37 teeth per group after adjustment for dropouts. Statistical analysis will include chi-square and Cochran's Q tests with significance set at p ≤ 0.05.
Eligibility criteria include healthy young adults with good oral hygiene and absence of parafunctional habits. Teeth with fractures, existing restorations, secondary caries, developmental defects, or periodontal compromise are excluded.
Methodologically, participants are randomly allocated using opaque sealed envelopes. In the control group, self-etch primer is applied before placement of BeautiSealant. In the laser group, a 940-nm diode laser is first applied to the occlusal surface, followed by the same primer and sealant application protocol. All restorations are light-cured and clinically evaluated for voids and occlusion
- Conditions
- Dental Caries
- Being tested
- phosphoric acid pretreatment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphoric acid pretreatmentOther
Also called laser pretreatment
surface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser
| Study group | Role | What they receive |
|---|---|---|
| Giomer Based Sealant Without Pre Treatmen | Active comparator | Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied without surface treatment Receives: Other: phosphoric acid pretreatment |
| Giomer Based Sealant With etchant Pre Treatmen | Active comparator | Giomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied with phosphoric acid surface treatment Receives: Other: phosphoric acid pretreatment |
| Giomer Based Sealant With laser Pre Treatmen | Active comparator | Giomer Based Sealant with laser Pre Treatment giomer based fissure sealnt will be applied with laser surface treatment Receives: Other: phosphoric acid pretreatment |
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: 1 year
Secondary outcomes (1)
Secondary Caries
Modified USPHS ( United States Public Health Service) criteria Alpha: Absence of the caries Charlie: Presence of the caries
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (estimated)
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
- NCT07612540
- Sponsor's protocol ID
- Fissure sealant
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 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 Diode Laser Pre-treatment in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07612540
- Acronym / sponsor ID
- Fissure sealant
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 May 2026 (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.
This randomized controlled trial evaluates the effect of diode laser pre-treatment on the retention and caries prevention of giomer-based fissure sealants in young adults aged 17-22 years. The study compares sealant application with and without diode laser conditioning on molars with ICDAS 0-2 fissures over a 12-month follow-up period. Primary outcome is sealant retention using Simonsen's criteria, while secondary outcome is caries prevention using modified USPHS criteria. The study hypothesizes that diode laser pre-treatment may improve sealant retention and enhance caries prevention by modifying enamel surface characteristics and improving sealant penetration.
Detailed description
The protocol investigates whether diode laser pre-treatment can improve the clinical performance of a giomer-based fissure sealant in young adults. The study is designed as a two-arm randomized controlled clinical trial evaluating sealant retention and caries prevention over a 12-month period.
The background emphasizes that pits and fissures of posterior teeth are highly susceptible to caries, and fissure sealants are an evidence-based preventive approach. Giomer sealants combine the advantages of resin composites and glass ionomer materials through S-PRG filler technology, offering fluoride release and simplified application using self-etch primer systems. However, concerns remain regarding their long-term retention. Diode laser enamel pre-treatment is proposed to enhance enamel surface roughness, improve sealant penetration, and increase resistance to acid dissolution, potentially improving retention and caries prevention.
The study aims to compare giomer-based sealant application with and without diode laser pre-treatment in patients aged 17-22 years having deep retentive fissures with ICDAS scores 0-2 in second and third molars. Primary outcome is sealant retention assessed using Simonsen's criteria, while secondary outcome is caries prevention evaluated using modified USPHS criteria at baseline, 6 months, and 12 months.
The null hypothesis states that diode laser pre-treatment will not significantly affect retention rate or caries prevention compared with conventional application. The protocol includes detailed sample size calculation based on previous literature, resulting in 37 teeth per group after adjustment for dropouts. Statistical analysis will include chi-square and Cochran's Q tests with significance set at p ≤ 0.05.
Eligibility criteria include healthy young adults with good oral hygiene and absence of parafunctional habits. Teeth with fractures, existing restorations, secondary caries, developmental defects, or periodontal compromise are excluded.
Methodologically, participants are randomly allocated using opaque sealed envelopes. In the control group, self-etch primer is applied before placement of BeautiSealant. In the laser group, a 940-nm diode laser is first applied to the occlusal surface, followed by the same primer and sealant application protocol. All restorations are light-cured and clinically evaluated for voids and occlusion
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Giomer Based Sealant Without Pre Treatmen | Active comparator | Other: phosphoric acid pretreatmentGiomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied without surface treatment |
| Giomer Based Sealant With etchant Pre Treatmen | Active comparator | Other: phosphoric acid pretreatmentGiomer Based Sealant Without Pre Treatment With laser giomer based fissure sealnt will be applied with phosphoric acid surface treatment |
| Giomer Based Sealant With laser Pre Treatmen | Active comparator | Other: phosphoric acid pretreatmentGiomer Based Sealant with laser Pre Treatment giomer based fissure sealnt will be applied with laser surface treatment |
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.
Key exclusion criteria (3 listed)
- •Patients with known allergic or adverse reaction to the tested materials.
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 |
|---|---|---|
| phosphoric acid pretreatmentAlso: laser pretreatmentsurface treatment with Bioactive Glass Air Abrasion giomer based fissure sealnt will be applied after surface treatment With laser | Other | Giomer Based Sealant With etchant Pre Treatmen, Giomer Based Sealant With laser Pre Treatmen, Giomer Based Sealant Without Pre Treatmen |
Primary outcome
Loss of sealant's retention
Time frame: 1 year
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: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phosphoric acid pretreatment in people with Dental Caries, run by Cairo University at 3 sites 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: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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: 1 year). 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 28 May 2026.