NCT04272866

Brief Summary

The aim of the study is :-

  1. 1.To evaluate and compare the microleakage of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
  2. 2.To evaluate and compare the bond strength of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
  3. 3.To clinically evaluate and compare the retention of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).
  4. 4.To clinically evaluate and compare the caries prevention effect of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 3, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

February 1, 2020

Last Update Submit

February 13, 2020

Conditions

Caries Prevention

Keywords

Caries preventionPit and fissure sealantClinproTriageEmbrace

Outcome Measures

Primary Outcomes (2)

  • Retention of the sealants

    Retention of the sealants will be evaluated according to modified Simon's criteria

    6 months

  • Caries prevention effect of the sealants

    Caries prevention effects will be evaluated according to modified Simon's criteria

    6 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Teeth in this group will be sealed with clinpro sealant

Other: Clinpro sealant

Group2

EXPERIMENTAL

Teeth in this group will be sealed with embrace wetbond sealant

Other: Embrace wetbond sealant

Group3

EXPERIMENTAL

Teeth in this group will be sealed with triage sealant

Other: Triage sealant

Interventions

Clinpro sealantOTHER

Resin based sealant

Group 1
Embrace wetbond sealantOTHER

Moisture tolerant hydrophilic resin based sealant

Group2
Triage sealantOTHER

Glass ionomer sealant

Group3

Eligibility Criteria

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

You may qualify if:

  • First permanent molars fully erupted with deep and retentive fissures,free of caries and free of any periapical radiolucency.
  • Males and Females 3- Age group between 6-9 years 4- Medically free 5- High caries risk children

You may not qualify if:

  • Medically compromised children
  • Uncooperative children.
  • Children with abnormalities in occlusion
  • children with abnormal oral habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Clinpro Sealant

Study Officials

  • Sarah E Alieldin

    Faculty of dentistry ain shams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Instructor at pediatric dentistry department faculty of dentistry ain shams university

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 17, 2020

Study Start

July 3, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

EG(1)