Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Resin Restorations

July 10, 2026 updated by: Ismail Dahshan

Clinical Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Preventive Resin Restorations

The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.

Primary objectives:

Assessment of retention rate and marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria and Simonsen's criteria.

Secondary objectives:

Assessment of stability of results after 3, 6 and 9months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental caries is one of the most common intraoral diseases, with serious consequences for both the individual patient and for the public in terms of medical, social, and economic concerns. The individual patient suffers from pain, dysfunction of the oral system, and reduced quality of life.

Caries predominantly attack the occlusal surfaces of premolars and molars during their eruption . On the other hand, smooth surface caries have shown a significant decline, likely a result of increased worldwide access to fluoride . In previous reports, an incomplete post-eruptive maturation , and the presence of narrow and deep fissures were blamed for the increased caries susceptibility of occlusal surfaces . It has been more than 40 years since the pit and fissure sealants were first used clinically. During this time, pit and fissure sealants have been shown to be effective in reducing the risk of occlusal caries . A study aimed to evaluate the effect of the previous application of a casein phosphopeptide-amorphous calcium phosphate paste (MI Paste, MI) and adhesive systems on the bond durability of a fissure sealant. Ninety-eight enamel blocks were obtained from proximal surfaces of erupted third molars.

Anthor study evaluated the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (Part I) and in vitro (Part II). Results showed no statistically significant differences between the test and control groups either clinically or in vitro. It is concluded that topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention .

The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Suez, Egypt
        • Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Absence of restorations or prior sealants on the teeth under study.
  • Patients have simple occlusal spot caries lesions
  • Age group 15 - 40 years.
  • Ability to return for periodic follow-up

Exclusion Criteria:

  • Patients with high DMFS.
  • Any fixed orthodontic appliances.
  • Smoking habit.
  • Pregnant and lactating mothers
  • Symptoms of dental pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
Device: Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
Experimental: Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
Device: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste
Group 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
Experimental: prevent seal, Itena, North America after treating with Biflourid Group
Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
Device: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid
Group 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
Experimental: prevent seal, Itena, North America after treating with MI Paste Group
Teeth treated with prevent seal, Itena, North America after treating with MI Paste, GC AmericaC America
Device: Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention rate of two types of pit and fissure sealants
Time Frame: After 3 months, 6 months and 9 months
Assessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
After 3 months, 6 months and 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal integrity assessments
Time Frame: After 3 months, 6 months and 9 months.
Assessment of marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
After 3 months, 6 months and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ismail Dahshan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 376/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It will be available if it needed

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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