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Status unknownNCT05127343Updated Nov 19, 2021

Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants

An interventional study of Sealing deep pits and fissures in Caries, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
12 Years to 16 Years
Sex
All
01

Study summary

The aim of the study is to clinically evaluate the retention and caries formation of hydrophilic fissure sealants among adolescents after one year.

02

Conditions studied

  • Caries

Keywords

  • Pit and fissure sealant
  • Retention rate
  • Caries formation
  • Hydrophilic sealant
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
  • Healthy patients with no history of previous systematic diseases that can affect their oral health and sealant application.
  • Cooperative patients who will allow the clinical applications

Exclusion criteria

Exclusion Criteria:

  • Uncooperative behaviour limiting the use of sealants throughout the procedure.
  • Patients with history of medical diseases, drug therapies or any other serious relevant problem.
  • Patients with well coalesced pits and fissures
  • Patients allergic to sealant material
  • Patients who underwent orthodontic treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Resin based sealant (Ultraseal XT Hydro)

    Procedure: Sealing deep pits and fissures

  • Active comparator
    Glass ionomer based sealant (Fugi Triage)

    Procedure: Sealing deep pits and fissures

Interventions

  • ProcedureSealing deep pits and fissures

    Application of the pit and fissure sealant

06

What researchers measure

Primary outcomes

  1. Retention rate

    * Full retention (FR): The material is fully present on the occlusal surfaces * Partially lost (PL): The material is present, but as a result of either wear or loss of the material, part of the previously sealed fissure, was exposed. * Totally lost (TL): No trace of the material to be detected on the surface

    Time frame: Change from baseline at 3, 6, 12 months

Secondary outcomes

  1. Caries formation

    Decayed: If the explorer caught on the tooth after insertion into the fissures

    Time frame: Change from baseline at 3, 6, 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05127343
Lead sponsor
Cairo University
Responsible party
Ghada Mohamed El-Amir Hashim Sediek (Master's Degree student- Faculty of Dentistry, Cairo University) — Principal investigator
First posted
Nov 19, 2021
Start date
Feb 2022 (estimated)
Primary completion
Jul 2022 (estimated)
Completion
Feb 2023 (estimated)
Last update
Nov 19, 2021

Study contacts

Iman I ElSayad, Professor
Contact
iman.sayad@dentistry.cu.edu.eg
0201005287368
Heba Helal, Post Phd
Contact
heba.helal@dentistry.cu.edu.eg
Iman I ElSayad, Professor
study director · Cairo University
Heba Helal
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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