NCT05988801

Brief Summary

evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin sealant in the pits and fissures sealing of the first permanent molars

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

July 13, 2023

Last Update Submit

August 9, 2023

Conditions

Pits and Fissures Sealant

Outcome Measures

Primary Outcomes (1)

  • Marginal discoloration

    Marginal discoloration will be measured with visual examination and recorded in Alfa: Lack of discoloration, Bravo: Margin discoloration, and Charlie: Discoloration under the sealant.

    6 months

Secondary Outcomes (2)

  • sealant retention

    6 months

  • Dental Caries

    6 months

Study Arms (2)

Glass ionomer sealant

EXPERIMENTAL

glass ionomer based sealant material

Other: Glass ionomer sealant

Resin sealant

ACTIVE COMPARATOR

resin-based sealant material

Other: Resin based sealant

Interventions

Glass ionomer sealantOTHER

glass ionomer-based sealant material

Glass ionomer sealant
Resin based sealantOTHER

resin-based sealant material

Resin sealant

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 6 to 9 years
  • Children with deeply stained fissures of the first permanent molars.
  • First permanent molars are completely erupted
  • The patient's willingness to receive treatment

You may not qualify if:

  • Special child, a child with compromised systemic health.
  • First permanent molars covered by operculum.
  • Children with high salivary flow when isolation will be impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Abrar Hossam Ahmed, Masters student

CONTACT

00201012979732abrar.saleh@dentistry.cu.edu.eg

Yasmin Mohamed Yousry, Lecturer

CONTACT

Yasmin.Yousry@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 14, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

November 1, 2024

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share