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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Caries Prevention
• Intervention / Treatment: Drug: Giomer pit and fissure sealant without etching; Drug: Giomer pit and fissure sealant with etching

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)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11555
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Giomer pit and fissure sealant without etching; S-PRG filler containig pit and fissure sealant without etching step; Other Names: Beautisealant without etching
Experimental: 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.	Drug: Giomer pit and fissure sealant with etching; S-PRG filler containig pit and fissure sealant with etching step; Other Names: Beautisealant with etching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
retention rate	To assess the sealant retention rate either total retention, partial loss or total loss	3 months, 6months , 1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Cairo, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 14, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Giomer sealant with etching

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes