Retention Rate of Giomer Pit and Fissure Sealant Applied With or Without Etching

Phase 4

Active, not recruiting

• Conditions: Caries Prevention
• Interventions: Drug: Giomer pit and fissure sealant without etching; Drug: Giomer pit and fissure sealant with etching

• Registration Number: NCT06509451
• Lead Sponsor: Cairo University

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-05-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-14
• Study First Posted: 2024-07-19
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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

Read More

Exclusion Criteria

1. ICDAS score > 1
2. Poor oral hygiene
3. Evidence of tempromandibular joint disorders or malocclusion

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Giomer pit and fissure sealant without etching	Giomer pit and fissure sealant without etching	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.
Giomer pit and fissure sealant with etching	Giomer pit and fissure sealant with etching	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.

Primary Outcome Measures

Name	Time	Method
retention rate	3 months, 6months , 1 year	To assess the sealant retention rate either total retention, partial loss or total loss

Trial Locations

Locations (1)

Faculty of dentistry, cairo university; 🇪🇬 Cairo, Egypt