Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-05 @ 6:26 PM
Study NCT ID:
NCT06509451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching
Sponsor:
Cairo University
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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:
1. ICDAS score 0 or 1
2. Satisfactory oral hygiene
3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
4. Satisfactory cooperative behavior
5. Age between 15- 30 years old
6. Males or females
7. Subjects who signed informed consent
Exclusion Criteria:
1. ICDAS score \> 1
2. Poor oral hygiene
3. 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)
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:
1. ICDAS score 0 or 1
2. Satisfactory oral hygiene
3. Normal salivary characteristics (consistency, pH, flow rate, buffering capacity)
4. Satisfactory cooperative behavior
5. Age between 15- 30 years old
6. Males or females
7. Subjects who signed informed consent
Exclusion Criteria:
1. ICDAS score \> 1
2. Poor oral hygiene
3. 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: