NCT03779893

Brief Summary

This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination \& VistaCAM.

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
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2019

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

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

December 17, 2018

Last Update Submit

January 12, 2019

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

  • Retention of sealant

    rate of sealant loss

    one year

Secondary Outcomes (1)

  • Caries incidence

    one year

Study Arms (2)

conventional group

ACTIVE COMPARATOR

Conventional resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant is administrated

Combination Product: 3M™ Clinpro™ Sealant.

bioactive group

EXPERIMENTAL

Bioactive Pits \& fissures sealant BioCoat® by Premier®.

Combination Product: BioCoat® by Premier®.

Interventions

BioCoat® by Premier®.COMBINATION_PRODUCT

Bioactive pits and fissure sealant

bioactive group
3M™ Clinpro™ Sealant.COMBINATION_PRODUCT

conventional pits and fissure sealant

conventional group

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
  • years.
  • Males or Females.
  • Co-operative patients approving to participate in the trial.

You may not qualify if:

  • Patients younger than 19 years old or older than 40 years old.
  • Pregnancy.
  • Disabilities.
  • Systemic disease or severe medical complications.
  • Allergic history concerning methacrylate.
  • Rampant caries.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share