Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06509451

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry, cairo university

Cairo, 11555, Egypt

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Giomer pit and fissure sealant without etching

Drug

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

Other names: Beautisealant without etching

Giomer pit and fissure sealant with etching

Drug

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

Other names: Beautisealant with etching

Primary outcomes

  1. retention rate

    Time frame: 3 months, 6months , 1 year

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.