Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05127343
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Caries	Procedure: Sealing deep pits and fissures	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: One Year Clinical Comparison Between Resin Based and Glass Ionomer Based Hydrophilic Fissure Sealants Among Adolescents: A Randomized Clinical Trial
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Resin based sealant (Ultraseal XT Hydro)	Procedure: Sealing deep pits and fissures; Application of the pit and fissure sealant
Active Comparator: Glass ionomer based sealant (Fugi Triage)	Procedure: Sealing deep pits and fissures; Application of the pit and fissure sealant

Outcome Measures

Primary Outcome Measures

1. Retention rate [Change from baseline at 3, 6, 12 months]

   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

Secondary Outcome Measures

1. Caries formation [Change from baseline at 3, 6, 12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry	Cairo		Egypt	11331

Sponsors and Collaborators

• Cairo University

Investigators

• Study Director: Iman I ElSayad, Professor, Cairo University
• Study Director: Heba Helal, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ghada Mohamed El-Amir Hashim Sediek, Master's Degree student- Faculty of Dentistry, Cairo University
• ClinicalTrials.gov Identifier: NCT05127343
• Other Study ID Numbers: CU-2021
• First Posted: Nov 19, 2021
• Last Update Posted: Nov 19, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ghada Mohamed El-Amir Hashim Sediek, Master's Degree student- Faculty of Dentistry, Cairo University: Pit and fissure sealant; Retention rate; Caries formation; Hydrophilic sealant

Study Results

No Results Posted as of Nov 19, 2021