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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05127343
Other study ID # CU-2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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