Resin InfiltrationPhase 4NCT06729788
Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars
A Phase 4 study testing ICON resin infiltration Material group in vivo, Resin-based fissure sealant group in vivo and ICON resin infiltration in vitro in people with Resin Infiltration and Pit and Fissure Sealant, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Resin Infiltration, Pit and Fissure Sealant, Permanent Molars
- What is being tested?
- ICON resin infiltration Material group in vivo, Resin-based fissure sealant group in vivo and ICON resin infiltration in vitro
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2025to 24 Dec 2025
- Phase
- Phase 4
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age of the children from 6 to 8 years.
- Healthy children free from any systemic disease.
- Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
- The eruption time of these molars should not exceed 3 years.
- No sign of pain or active periodontal disease in the selected teeth.
Who cannot join
- Children with fillings or sealants in the selected teeth.
- Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
- Children with an allergy to any drug, such as resin restorative material.
- Children with Extremely poor oral hygiene.
- Hypoplastic teeth.
- Children with bruxism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Salsabeel M Abdelgaffar
Tanta, ELGharbia, 31527
Salsabeel M Abdelgaffar, B.D.S, +20 11 17010546, PG_170913@dent.tanta.edu.eg
Fatma A El-Hendawy, Professor
About this study
Official title: Evaluation of Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (In Vivo& In Vitro)
The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.
Read the detailed description
Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.
- Being tested
- ICON resin infiltration Material group in vivo, Resin-based fissure sealant group in vivo, ICON resin infiltration in vitro, Resin-based fissure sealant in vitro
- 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.
ICON resin infiltration Material group in vivoDrug
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK).
Resin-based fissure sealant group in vivoDrug
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)
ICON resin infiltration in vitroDrug
The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro
Resin-based fissure sealant in vitroDrug
The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro
| Study group | Role | What they receive |
|---|---|---|
| ICON resin infiltration group (in vivo) | Experimental | The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) Receives: Drug: ICON resin infiltration Material group in vivo |
| Resin-based fissure sealant group (in vivo) | Placebo comparator | The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) Receives: Drug: Resin-based fissure sealant group in vivo |
| ICON resin infiltration Material (in vitro) | Experimental | The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) Receives: Drug: ICON resin infiltration in vitro |
| Resin-based fissure sealant (in vitro) | Placebo comparator | The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)** Receives: Drug: Resin-based fissure sealant in vitro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
172 permanent mandibular molars out of 86 children will be randomly allocated into two equal groups. Group 1: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). Group 2: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).For application of ICON, an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source. A second layer of the Icon Infiltrate was applied and cured in the same way. For Heliosael application, The sealant will be carefully applied starting from the maximum depth of the central fissure up towards two. Sealant retention will be evaluated using Simonsen's criteria. (Completely present: no sealant ledge is present, Partially present: part of the sealed pit or fissure, Complete missing: no sealant ledge is present.
Measured: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months
Secondary outcomes (1)
Evaluate and compare the microleakage and penetration depth of the two sealant materials
20 teeth will be randomly assigned into two equal experimental groups . Experimental Group I: The fissure of selected teeth will be sealed with ICON resin infiltration. Experimental Group II: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).
After removal from the dye teeth will be rinsed with water, cleaned, and sectioned longitudinally through the center of the restorations in a buccolingual direction with a double-sided diamond disc and will be given a code number to permit blind evaluation. For each specimen, the dye penetration along the buccal and lingual margins on each sectioned surface will be digitally photographed at 10x under a stereomicroscope. The degree of microleakage was scored by a single observer.
Measured: thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start4 Jan 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion24 Dec 2025 (estimated)
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 Resin InfiltrationStudies of the same condition, open and under way.
- More trials run by Tanta 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabeel Mahmoud Abdelgaffar Shalaby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729788
- Sponsor's protocol ID
- Resin Infiltrate
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lam PPY, Sardana D, Ekambaram M, Lee GHM, Yiu CKY. Effectiveness of Pit and Fissure Sealants for Preventing and Arresting Occlusal Caries in Primary Molars: A Systematic Review and Meta-Analysis. J Evid Based Dent Pract. 2020 Jun;20(2):101404. doi: 10.1016/j.jebdp.2020.101404. Epub 2020 Jan 29.
PubMed 32473795
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (In Vivo& In Vitro)
- ClinicalTrials.gov ID
- NCT06729788
- Acronym / sponsor ID
- Resin Infiltrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Jan 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 11 Dec 2024 (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 this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.
Detailed description
Using the resin infiltration technique as a different approach for sealing pits and fissures creates a diffusion barrier as resin infiltrate tends to inhibit enamel pores that serve as diffusion channels for acids and dissolved minerals within the lesion body. A low-viscosity resin that can penetrate into caries lesions, which is referred to as resin infiltration technique. The mechanisms associated with this method depend on the infiltration of subsurface lesions with low-viscosity light-curing resins after eroding the highly mineralized surface layer and increasing penetration depth. This method is believed to overcome the limitations of sealant applications and is considered to be a better alternative for the treatment of initial caries lesions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICON resin infiltration group (in vivo) | Experimental | Drug: ICON resin infiltration Material group in vivoThe fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) |
| Resin-based fissure sealant group (in vivo) | Placebo comparator | Drug: Resin-based fissure sealant group in vivoThe fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) |
| ICON resin infiltration Material (in vitro) | Experimental | Drug: ICON resin infiltration in vitroThe fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) |
| Resin-based fissure sealant (in vitro) | Placebo comparator | Drug: Resin-based fissure sealant in vitroThe fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael)** |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age of the children from 6 to 8 years.
- Healthy children free from any systemic disease.
- Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
- The eruption time of these molars should not exceed 3 years.
- No sign of pain or active periodontal disease in the selected teeth.
Key exclusion criteria (6 listed)
- Children with fillings or sealants in the selected teeth.
- Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
- Children with an allergy to any drug, such as resin restorative material.
- Children with Extremely poor oral hygiene.
- Hypoplastic teeth.
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 |
|---|---|---|
| ICON resin infiltration Material group in vivoThe fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). | Drug | ICON resin infiltration group (in vivo) |
| Resin-based fissure sealant group in vivoThe fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) | Drug | Resin-based fissure sealant group (in vivo) |
| ICON resin infiltration in vitroThe fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK) in vitro | Drug | ICON resin infiltration Material (in vitro) |
| Resin-based fissure sealant in vitroThe fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael) in vitro | Drug | Resin-based fissure sealant (in vitro) |
Primary outcome
Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
Time frame: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months
172 permanent mandibular molars out of 86 children will be randomly allocated into two equal groups. Group 1: The fissure of selected teeth will be sealed with ICON resin infiltration Material (DMG Dental UK). Group 2: The fissure of selected teeth will be sealed with resin-based fissure sealant (Heliosael).For application of ICON, an ample amount of Icon-Infiltrate is applied into the fissure away from the direct light of the dental unit and let sit for 3 minutes. After excess removal, it will be cured with a light source. A second layer of the Icon Infiltrate was applied and cured in the same way. For Heliosael application, The sealant will be carefully applied starting from the maximum depth of the central fissure up towards two. Sealant retention will be evaluated using Simonsen's criteria. (Completely present: no sealant ledge is present, Partially present: part of the sealed pit or fissure, Complete missing: no sealant ledge is present.
1 secondary outcome
Evaluate and compare the microleakage and penetration depth of the two sealant materials
Time frame: thirty seconds for application of Heliosael.The children will be recalled at 3, 6, and 9 months
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 11 Dec 2024.
- Results publication: PubMed 32473795Lam PPY, Sardana D, Ekambaram M, Lee GHM, Yiu CKY. Effectiveness of Pit and Fissure Sealants for Preventing and Arresting Occlusal Caries in Primary Molars: A Systematic Review and Meta-Analysis. J Evid Based Dent Pract. 2020 Jun;20(2):101404. doi: 10.1016/j.jebdp.2020.101404. Epub 2020 Jan 29.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ICON resin infiltration Material group in vivo, Resin-based fissure sealant group in vivo and ICON resin infiltration in vitro in people with Resin Infiltration and Pit and Fissure Sealant, run by Tanta 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 5 inclusion and 6 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 11 Dec 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Salsabeel M Abdelgaffar, B.D.S (+20 11 17010546, PG_170913@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria. (time frame: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 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 NCT06729788, 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 11 Dec 2024.