NCT07705633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

April 14, 2026

Last Update Submit

July 10, 2026

Conditions

RetentionFissure SealantsResinPit and Fissure Sealants

Keywords

Remineralizing AgentsResin RestorationsSealantsPit and Fissure Sealant

Outcome Measures

Primary Outcomes (1)

  • Retention rate of two types of pit and fissure sealants

    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 Outcomes (1)

  • marginal integrity assessments

    After 3 months, 6 months and 9 months.

Study Arms (4)

Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group

EXPERIMENTAL

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

Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group

EXPERIMENTAL

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

prevent seal, Itena, North America after treating with Biflourid Group

EXPERIMENTAL

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

prevent seal, Itena, North America after treating with MI Paste Group

EXPERIMENTAL

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

Interventions

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

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

Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group
Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI PasteDEVICE

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

Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group
Group 3 : Teeth treated with prevent seal, Itena, North America after treating with BiflouridDEVICE

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

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

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

prevent seal, Itena, North America after treating with MI Paste Group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez canal university

Suez, Egypt

Location

MeSH Terms

Conditions

Van der Woude syndrome

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

April 14, 2026

First Posted

July 15, 2026

Study Start

February 28, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

It will be available if it needed

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

EG(1)