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

Caries, Dental Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03779893
• Other study ID #: 14011989
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2019
• Est. completion date: March 2020

Study information

• Verified date: January 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: March 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

Combination Product:
• BioCoat® by Premier®.
Bioactive pits and fissure sealant
• 3M™ Clinpro™ Sealant.
conventional pits and fissure sealant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of sealant	rate of sealant loss	one year
Secondary	Caries incidence	rate of caries initiation	one year