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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07705633
Enrollment
44
Registered
2026-07-15
Start date
2025-02-28
Completion date
2026-01-01
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fissure Sealants, Pit and Fissure Sealants, Resin, Retention

Keywords

Remineralizing Agents, Resin Restorations, Sealants, Pit and Fissure Sealant

Brief summary

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.

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.

Interventions

DEVICEGroup 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

DEVICEGroup 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

DEVICEGroup 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

DEVICEGroup 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

Sponsors

Ismail Dahshan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Retention rate of two types of pit and fissure sealantsAfter 3 months, 6 months and 9 monthsAssessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria

Secondary

MeasureTime frameDescription
marginal integrity assessmentsAfter 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026