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

NCT06509451 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Giomer sealant with etching
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries Prevention

Outcome Measures

Primary Outcomes (1)

• retention rate

  To assess the sealant retention rate either total retention, partial loss or total loss

  3 months, 6months , 1 year

Study Arms (2)

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.

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.

Drug: Giomer pit and fissure sealant with etching

Interventions

Giomer pit and fissure sealant without etching DRUG

S-PRG filler containig pit and fissure sealant without etching step

Also known as: Beautisealant without etching

Giomer pit and fissure sealant without etching

Giomer pit and fissure sealant with etching DRUG

S-PRG filler containig pit and fissure sealant with etching step

Also known as: Beautisealant with etching

Giomer pit and fissure sealant with etching

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• ICDAS score \> 1
• Poor oral hygiene
• Evidence of tempromandibular joint disorders or malocclusion

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry, cairo university

Cairo, 11555, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39511504 DERIVED

MeSH Terms

Interventions

Pit and Fissure Sealants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Cairo

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)