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Completed

NCT Number: NCT07705633

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

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Key information

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suez canal university

Suez, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid

Device

Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany

Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste

Device

Group 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America

Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid

Device

Group 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany

Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste

Device

Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ismail Dahshan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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