Back to resultsClinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars
Primary Purpose
Caries, Dental
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BioCoat® by Premier®.
3M™ Clinpro™ Sealant.
Sponsored by
About this trial
This is an interventional prevention trial for Caries, Dental
Eligibility Criteria
Inclusion Criteria of participants:
- 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 of participants:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conventional group
bioactive group
Arm Description
Conventional resin based Pits & fissures sealant 3M™ Clinpro™ Sealant is administrated
Bioactive Pits & fissures sealant BioCoat® by Premier®.
Outcomes
Primary Outcome Measures
Retention of sealant
rate of sealant loss
Secondary Outcome Measures
Caries incidence
rate of caries initiation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03779893
Brief Title
Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars
Official Title
Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
Conventional resin based Pits & fissures sealant 3M™ Clinpro™ Sealant is administrated
Arm Title
bioactive group
Arm Type
Experimental
Arm Description
Bioactive Pits & fissures sealant BioCoat® by Premier®.
Intervention Type
Combination Product
Intervention Name(s)
BioCoat® by Premier®.
Intervention Description
Bioactive pits and fissure sealant
Intervention Type
Combination Product
Intervention Name(s)
3M™ Clinpro™ Sealant.
Intervention Description
conventional pits and fissure sealant
Primary Outcome Measure Information:
Title
Retention of sealant
Description
rate of sealant loss
Time Frame
one year
Secondary Outcome Measure Information:
Title
Caries incidence
Description
rate of caries initiation
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria of participants:
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 of participants:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars
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