Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions

Cairo University (CU)

Status: Unknown

Conditions: Dental Caries

Treatments: Procedure: cervical restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT05149209

cons2021

Details and patient eligibility

About

• This study will be conducted to evaluate and compare the clinical performance of fluoride, calcium, and phosphate-releasing new bioactive material versus a fluoride-releasing hybrid restorative material in cervical lesions for one-year follow-up.
• The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.

Full description

two groups of 30 patients will receive cervical restorations by using calcium and phosphate releasing hybrid restorative material (Activa™ Presto, Pulpdent®, USA), or a fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan). Then these restorations will be evaluated at baseline, 3 months, 6 months, 9 months, and 12 months according to modified USPHS criteria in terms of marginal adaptation, Marginal discoloration, recurrent caries, retention, surface texture, and Post-operative sensitivity.

• Examination and selection of all patients will be done according to inclusion and exclusion criteria.
• A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation followed by the placement of restorative material according to the randomization sequence.
• For the intervention: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride, calcium, and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA) using a 19-gauge applicator tip on the syringe and light-curing for 20 seconds between each 2mm layer.
• For the control group: selective etching to enamel and universal bond agent to all the cavity will be applied first, followed by filling of the cavity with fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan) and will be light polymerized using a light-emitting diode (LED) light-curing unit for 10 seconds between each 2mm layer.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a)Inclusion Criteria of participants:

  • Male or female gender.
  • Only co-operative patients will be approved to participate in the trial.
  • Medically free adult patients.
  • The age range of the patients is 18-40 years. b)Inclusion Criteria of teeth:
  • Small to moderate cervical lesion.
  • Vital upper or lower teeth with no signs of irreversible pulpitis.
  • Caries extension shouldn't exceed mesiodistal width and inciso(occluso)-gingival length not exceed incisal (occlusal) one third.

Exclusion criteria

• a)Exclusion criteria of participants:

  • Allergic history concerning methacrylates

  • Pregnancy

  • Heavy smoking; xerostomia

  • Lack of compliance

  • Patients with disabilities.

  • Patients having systemic diseases or severe medically compromised.

  • Patients with severe bruxism, clenching, or temporomandibular joint disorders.

    b)Exclusion criteria of the teeth:

  • Deep defects (close to the pulp, less than 1 mm distance).

  • Periapical pathology or signs of pulpal pathology.

  • Possible prosthodontic restoration of teeth.

  • Heavy occlusion and occlusal contacts or history of bruxism.

  • Pulpitis, non-vital or endodontically treated teeth.

  • Sever periodontal affection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).

Experimental group

Description:

ACTIVA Presto is a novel bioactive material with a mineral-enriched hydrophilic resin base and a patented rubberized component that resists abrasion and wear with high release and recharge of not only fluoride but also calcium and phosphate ions. It doesn't contain BIS-GMA, Bisphenol A, or BPA derivatives.

Treatment:

Procedure: cervical restoration

Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).

Active Comparator group

Description:

Giomer is a hybrid restorative material that contains a resin base and pre-reacted glass ionomer. S-PRG (surface reaction type) technology provides some properties of GI such as fluoride release and recharge which helps prevent recurrent caries.

Treatment:

Procedure: cervical restoration