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

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

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.

Study Overview

• Status: Unknown
• Conditions: Demineralization, Tooth; Demineralization, Fissure; Non-Cavitated Caries
• Intervention / Treatment: Other: Fissure sealing

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bioactive resin (Giomer); This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures	Other: Fissure sealing; The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
Experimental: Conventional resin; This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures	Other: Fissure sealing; The materials will be applied to the demineralized fissures as stated in manufacturer's instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2019
• Primary Completion (Anticipated): March 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization
• Other Study ID Numbers: 812014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will be assessed collectively for ll participants and statistically analyzed and published with the results. Other data can be provided apon request if ethically approved.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No