Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants

NCT ID: NCT05127343

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2023-02-28

Brief Summary

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

Detailed Description

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Conditions

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Caries

Keywords

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Pit and fissure sealant Retention rate Caries formation Hydrophilic sealant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Resin based sealant (Ultraseal XT Hydro)

Group Type ACTIVE_COMPARATOR

Sealing deep pits and fissures

Intervention Type PROCEDURE

Application of the pit and fissure sealant

Glass ionomer based sealant (Fugi Triage)

Group Type ACTIVE_COMPARATOR

Sealing deep pits and fissures

Intervention Type PROCEDURE

Application of the pit and fissure sealant

Interventions

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Sealing deep pits and fissures

Application of the pit and fissure sealant

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohamed El-Amir Hashim Sediek

Master's Degree student- Faculty of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iman I ElSayad, Professor

Role: STUDY_DIRECTOR

Cairo University

Heba Helal

Role: STUDY_DIRECTOR

Cairo University

Locations

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Faculty of dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Iman I ElSayad, Professor

Role: CONTACT

Phone: 0201005287368

Email: [email protected]

Heba Helal, Post Phd

Role: CONTACT

Email: [email protected]

Facility Contacts

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Iman I ElSayad, Professor

Role: primary

Other Identifiers

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CU-2021

Identifier Type: -

Identifier Source: org_study_id