New Bioactive Restorative Material vs GIC in Restoration of Proximal Lesions

Sponsor
Rana Ayman Kamal (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04365283
Collaborator
(none)
22
2
17.9

Study Details

Study Description

Brief Summary

ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.

Condition or Disease Intervention/Treatment Phase
  • Procedure: New Bioactive Restorative Material (ACTIVA Presto)
  • Other: High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)
N/A

Detailed Description

High caries risk patients are those who have high DMF index, high sugar intake, poor oral hygiene, inadequate salivary flow, low pH level, as well as deficient fluoride exposure.

Therefore, their management has to be adequate and proper. To overcome these setbacks, glass ionomer cements that have advantages such as similar coefficient of thermal expansion to natural tooth tissue, physicochemical adhesion to tooth structure, biocompatability, fluoride release, low shrinkage and low marginal leakage as well as anticaries properties and increased remineralization interproximally ,which is especially beneficial in high risk caries patients, have been considered as an alternative restorative material to composite and amalgam. To enhance the mechanical properties of GIs, their constituents have been modified Comparatively, resin-modified glass ionomer (RMGIs) with a longer working time, faster setting, higher early strength, and improved appearance and translucency. Unfortunately, the RMGI's mechanical properties of are different to resin composites. Progressive development of material sciences has resulted in the introduction of bioactive restorative materials. These materials can activate a tissue repair mechanism for or synthesis and elicit a response from teeth and surrounding environment. ACTIVA BioACTIVE products are allegedly the first dental resins with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. These bioactive materials actively participate in the cycles of ionic exchange that regulate the natural chemistry of our teeth and saliva and contribute to the maintenance of tooth structure and oral health. They are claimed to have the strength, esthetics and physical properties of composites and are more bioactive than glass ionomers, combining the best attributes of both materials without compromising either one.

Activa Presto light-cured material from Pulpdent is the company's latest product that features biomimicry as Activa Bioactive dual-cured material. The material diffuses fluoride, calcium, and phosphate ions that fortify the saliva and help replace essential minerals that are lost in the decay process. This highly esthetic, light-cured resin contains these ions in a stackable resin matrix that holds its shape and does not slump. This durable product is resistant to fracturing and wear, especially so on the thin areas of enamel bevels, and is indicated for all restorative procedures replacing dentin and/or enamel, anterior or posterior.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of New Bioactive Restorative Material Versus High Viscosity Glass Hybrid Reinforced Glass Ionomer in Restoration of Proximal Lesions: A Randomized Clinical Trial
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: New Bioactive Restorative Material

ACTIVA Presto restorative material

Procedure: New Bioactive Restorative Material (ACTIVA Presto)
New Bioactive Restorative Material

Active Comparator: High Viscosity Glass Hybrid Reinforced Glass Ionomer

EQUIA Forte restorative material

Other: High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)
High Viscosity Glass Hybrid Reinforced Glass Ionomer

Outcome Measures

Primary Outcome Measures

  1. Proximal Contact (modified USPHS criteria) [6 months]

    Ordinal(Alfa/Bravo/Charlie)

  2. Proximal Contact (modified USPHS criteria) [1 Year]

    Ordinal(Alfa/Bravo/Charlie)

Secondary Outcome Measures

  1. Retention(modified USPHS criteria) [6 Months]

    Ordinal(Alpha/Charlie)

  2. Retention(modified USPHS criteria) [1 Year]

    Ordinal(Alpha/Charlie)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Proximal lesions in posterior premolars and molars and Age 20-40 years

Exclusion Criteria:

Low caries risk patients. Lack of compliance Class V in molars Systemic diseases or severe medical complications. Pregnancy. Rampant caries Disabilities

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rana Ayman Kamal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rana Ayman Kamal, Resident, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Cairo University
ClinicalTrials.gov Identifier:
NCT04365283
Other Study ID Numbers:
  • 25091992
First Posted:
Apr 28, 2020
Last Update Posted:
Sep 22, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 22, 2020