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Bioactive Restorative vs GIC Modified Glass Ionomer in Restoration of Cervical Lesions: Randomized Controlled Trial (ActivaPresto)

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Clinical Performance Using Modified USPHS Criteria

Treatments

Other: New Bioactive Restorative Material

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent).

Full description

The resin composites used with bonding agents are popularly used for the restoration of cervical lesions. These materials exhibit high strength and physical properties as well as good esthetic property but they don't offer the chemical bonding and fluoride release potentials necessary for managing high caries risk patients (Khoroushi et al., 2012).

Fluorides containing restorative materials have been advocated as the material of choice for restoring cervical lesions in high caries risk patients since this kind of material offers chemical bonding, fluoride release, and caries inhibiting potentials. Conventional Glass Ionomer and Resin modified glass ionomer restorative materials have high fluoride release and could be specified clinically to repair cervical lesions in high caries risk patients. However, clinical acceptance of these materials has been limited because of their low tensile strength, brittleness, and low resistance to wear (Somani et al., 2016).

Bioactive restorative materials are relatively new in dentistry. Activa BioACTIVE (Pulpdent Corporation, Watertown, MA) dual cured material is the first dental restoratives with a bioactive resin matrix, shock-absorbing resin component and reactive glass ionomer fillers designed to mimic the physical and chemical properties of natural teeth. It is a highly esthetic bioactive hydrophilic composite that bonds chemically to teeth, seals against 4 microleakage and releases more calcium, phosphate, and fluoride. It is delivered via a dualbarrel, automix syringe using a special dispensing gun. The company states that Activa is more bioactive than glass ionomers while more durable and fracture resistant than composites (ACTIVA BioACTIVE RESTORATIVE - Pulpdent). Activa Presto light-cured material from Pulpdent is the company's newest product that features biomimicry as Activa Bioactive dual-cured material. It is available in a 1.2 mL syringe for easy application, and no longer need for a special dispensing gun to apply the material. Consequently, placement of the resin is precise and highly adaptive to the cavity margins. It is highly radiopaque (250%), so it can be easily followed on radiographs.

There are eight esthetic shades: A1, A2, A3, A3.5, B1, BW and two new darker cervical shades A4 and A6 which can be useful in geriatric patients. 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 (ACTIVA Presto - Pulpdent).

Enrollment

36 estimated patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Cervical carious lesions anterior teeth and premolars.
  2. Age 20-40 years.

Exclusion criteria

  1. Rampant caries.
  2. Pregnancy.
  3. Disabilities.
  4. Oral Dryness.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

36 participants in 2 patient groups

New Bioactive Restorative Material
Experimental group
Description:
Activa Presto Bioactive restorative material
Treatment:
Other: New Bioactive Restorative Material
Resin Modified Glass Ionomer
Active Comparator group
Description:
Fuji II
Treatment:
Other: New Bioactive Restorative Material

Trial contacts and locations

1

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Central trial contact

Amera 1 Nabel, BDS

Data sourced from clinicaltrials.gov

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