Caries PreventionPhase 4NCT06509451
Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching
A Phase 4 study testing Giomer pit and fissure sealant without etching and Giomer pit and fissure sealant with etching in people with Caries Prevention, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same… Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Prevention
- What is being tested?
- Giomer pit and fissure sealant without etching and Giomer pit and fissure sealant with etching
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Aug 2024
- Phase
- Phase 4
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ICDAS score 0 or 1
- Satisfactory oral hygiene
- Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
- Satisfactory cooperative behavior
- Age between 15- 30 years old
- Males or females
- Subjects who signed informed consent
Who cannot join
- ICDAS score > 1
- Poor oral hygiene
- Evidence of tempromandibular joint disorders or malocclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention Rate of Giomer S-PRG Filler Containing Pit and Fissure Sealant Applied With or Without Etching by Using Split Mouth Technique: Randomized Clinical Trial
The aim of this study is to evaluate the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.
Read the detailed description
Study Settings:
The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant.
Recruitment:
Participants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.
Eligibility Criteria:
Inclusion Criteria:
- ICDAS score 0 or 1
- Satisfactory oral hygiene
- Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
- Satisfactory cooperative behavior
- Age between 15- 30 years old
- Males or females
- Subjects who signed informed consent
Exclusion Criteria:
- ICDAS score > 1
- Poor oral hygiene
- Evidence of tempromandibular joint disorders or malocclusion
Materials used in this trial are the Giomer S-PRG filler containing pit and fissure sealant (Beautisealant) and its self etching primer (Beauisealant primer).
Control group:
In the control group, an adequate amount of primer will be applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant will be applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.
Intervention Group:
In the intervention group, the same steps will be done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.
Outcome Assessment:
The results of sealant retention were assessed according to the following criteria (Simonsen):
A complete retention B partial loss (B1, without caries; B2, with caries) C complete loss (C1, without caries; C2, with caries)
- Conditions
- Caries Prevention
- Being tested
- Giomer pit and fissure sealant without etching, Giomer pit and fissure sealant with etching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer pit and fissure sealant without etchingDrug
Also called Beautisealant without etching
S-PRG filler containig pit and fissure sealant without etching step
Giomer pit and fissure sealant with etchingDrug
Also called Beautisealant with etching
S-PRG filler containig pit and fissure sealant with etching step
| Study group | Role | What they receive |
|---|---|---|
| Giomer pit and fissure sealant without etching | Active comparator | In the control group, an adequate amount of primer is applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant is applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions. Receives: Drug: Giomer pit and fissure sealant without etching |
| Giomer pit and fissure sealant with etching | Experimental | In the intervention group, the same steps are done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application. Receives: Drug: Giomer pit and fissure sealant with etching |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rate
To assess the sealant retention rate either total retention, partial loss or total loss
Measured: 3 months, 6months , 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion1 Aug 2024 (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 Caries PreventionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar abd elmageed ahmed, Cairo University
- Investigators
- Cairo, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509451
- Sponsor's protocol ID
- Giomer sealant with etching
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elmokanen MA, Gad HMA. Retention rate of giomer S-PRG filler containing pit and fissure sealant applied with or without etching: a randomized clinical trial. BMC Oral Health. 2024 Nov 7;24(1):1356. doi: 10.1186/s12903-024-05096-7.
PubMed 39511504
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Rate of Giomer S-PRG Filler Containing Pit and Fissure Sealant Applied With or Without Etching by Using Split Mouth Technique: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06509451
- Acronym / sponsor ID
- Giomer sealant with etching
- Conditions
- Caries Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 19 Jul 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 the retention rate of Giomer S-PRG filler containing pit and fissure sealant applied with or without etching by using split mouth technique.with null hypothesis that Giomer S-PRG filler containing pit and fissure sealant applied either with or without etching will have the same retention rate.
Detailed description
Study Settings:
The study will be carried out at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University in Egypt. Ethical approval is taken from the Research Ethics Committee of the faculty of Dentistry, Cairo University. Signed informed consent is signed by each participant.
Recruitment:
Participants are recruited from the patients' flow at the clinics of the Conservative Dentistry Department of Faculty of Dentistry, Cairo university.
Eligibility Criteria:
Inclusion Criteria:
- ICDAS score 0 or 1
- Satisfactory oral hygiene
- Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
- Satisfactory cooperative behavior
- Age between 15- 30 years old
- Males or females
- Subjects who signed informed consent
Exclusion Criteria:
- ICDAS score > 1
- Poor oral hygiene
- Evidence of tempromandibular joint disorders or malocclusion
Materials used in this trial are the Giomer S-PRG filler containing pit and fissure sealant (Beautisealant) and its self etching primer (Beauisealant primer).
Control group:
In the control group, an adequate amount of primer will be applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant will be applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions.
Intervention Group:
In the intervention group, the same steps will be done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application.
Outcome Assessment:
The results of sealant retention were assessed according to the following criteria (Simonsen):
A complete retention B partial loss (B1, without caries; B2, with caries) C complete loss (C1, without caries; C2, with caries)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Giomer pit and fissure sealant without etching | Active comparator | Drug: Giomer pit and fissure sealant without etchingIn the control group, an adequate amount of primer is applied onto the enamel surface with a microbrush, left undisturbed for 5 s and then air-dried gently to avoid blowing it away. Beautisealant is applied directly from the syringe into pits and fissures and light-cured for 10 s, according to the manufacturer's instructions. |
| Giomer pit and fissure sealant with etching | Experimental | Drug: Giomer pit and fissure sealant with etchingIn the intervention group, the same steps are done except for an additional initial etching step with phosphoric acid etching for 30 s (for the uncut enamel) before primer and sealant application. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ICDAS score 0 or 1
- Satisfactory oral hygiene
- Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
- Satisfactory cooperative behavior
- Age between 15- 30 years old
Key exclusion criteria (3 listed)
- ICDAS score > 1
- Poor oral hygiene
- Evidence of tempromandibular joint disorders or malocclusion
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 |
|---|---|---|
| Giomer pit and fissure sealant without etchingAlso: Beautisealant without etchingS-PRG filler containig pit and fissure sealant without etching step | Drug | Giomer pit and fissure sealant without etching |
| Giomer pit and fissure sealant with etchingAlso: Beautisealant with etchingS-PRG filler containig pit and fissure sealant with etching step | Drug | Giomer pit and fissure sealant with etching |
Primary outcome
retention rate
Time frame: 3 months, 6months , 1 year
To assess the sealant retention rate either total retention, partial loss or total loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 39511504Elmokanen MA, Gad HMA. Retention rate of giomer S-PRG filler containing pit and fissure sealant applied with or without etching: a randomized clinical trial. BMC Oral Health. 2024 Nov 7;24(1):1356. doi: 10.1186/s12903-024-05096-7.
- Individual participant dataSharing planned: No
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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.
Cairo principal investigator
Cairo University
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 Giomer pit and fissure sealant without etching and Giomer pit and fissure sealant with etching in people with Caries Prevention, 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 7 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: status not confirmed, as of the sponsor's last update on 30 Jul 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. 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?
Results are not available in the source record.
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?
retention rate (time frame: 3 months, 6months , 1 year). 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 NCT06509451, 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 30 Jul 2024.