Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars

NCT ID: NCT03779893

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed.

With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.

Conditions

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Caries, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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conventional group

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

Group Type ACTIVE_COMPARATOR

3M™ Clinpro™ Sealant.

Intervention Type COMBINATION_PRODUCT

conventional pits and fissure sealant

bioactive group

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

Group Type EXPERIMENTAL

BioCoat® by Premier®.

Intervention Type COMBINATION_PRODUCT

Bioactive pits and fissure sealant

Interventions

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BioCoat® by Premier®.

Bioactive pits and fissure sealant

Intervention Type COMBINATION_PRODUCT

3M™ Clinpro™ Sealant.

conventional pits and fissure sealant

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Patients with bilateral caries susceptible fissures in molars showing no signs of caries.
* 19 - 40 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Fathi Abdelsalam

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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14011989

Identifier Type: -

Identifier Source: org_study_id

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