Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants

Caries Clinical Trial

Official title:

One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05127343
• Other study ID #: CU-2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2022
• Est. completion date: February 2023

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: Iman I ElSayad, Professor
• Phone: 0201005287368
• Email: iman.sayad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: February 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries

Intervention

Procedure:
• Sealing deep pits and fissures
Application of the pit and fissure sealant

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline at 3, 6, 12 months
Secondary	Caries formation	Decayed: If the explorer caught on the tooth after insertion into the fissures	Change from baseline at 3, 6, 12 months