Compariing a Bioactive Resin Material Used As A Fissure Sealant To A Conventional Resin

Demineralization, Tooth Clinical Trial

Official title:

The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04052802
• Other study ID #: 812014
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2019
• Est. completion date: April 30, 2021

Study information

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

Clinical Trial Summary

The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.

Description:

Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.

The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients with good oral hygiene

• Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible

Exclusion Criteria:

• Medical Problems or Pregnancy

• Lack of patient's approval and compliance

• Presence of abnormal oral, medical, or mental condition

• Known allergy of resin-based materials

• Previous placements of sealants or restorations

• Bruxism or mal-occlusion

Related Conditions & MeSH terms

• Demineralization, Fissure
• Demineralization, Tooth
• Non-Cavitated Caries
• Tooth Demineralization

Intervention

Other:
• Fissure sealing
The materials will be applied to the demineralized fissures as stated in manufacturer's instructions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.	18 months
Secondary	Marginal integrity	The materials margins will be assessed for their marginal seal using FDI criteria using a WHO probe. Scoring will be made from 1-5 by FDI criteria then statistically analyzed	18 months
Secondary	Caries progression	The demineralized fissures will be monitored for caries arrest or progression. The assessment will be made by ICDAS II criteria comparing the scores from baseline.	18 months