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

One-Year Clinical Evaluation of a Fluoride, Calcium and Phosphate-Releasing New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions: A Randomized Clinical Trial.

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: cervical restoration

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nourhan K Mohamed, B.D.S; Phone Number: 01003787886; Email: nourhankhaled@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Maadi
    • Cairo, Maadi, Egypt, 11728
      • Nourhan Khaled Mohamed Samir
      • Contact: Nourhan K Mohamed, B.D.S.; Phone Number: 002 01003787886; Email: Nourhankhaled@dentistry.cu.edu.eg
      • Principal Investigator: Nourhan K Mohamed, B.D.S

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).; 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.	Procedure: cervical restoration; A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done.
Active Comparator: Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).; 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.	Procedure: cervical restoration; A class v cavity will be prepared after local anesthesia has been given as required. Rubber dam isolation will be done. Selective enamel etching and a universal adhesive agent (Beautibond, Shofu, Japan) will be applied over all the cavity surfaces. Followed by, placement of restorative material according to the randomization sequence. Finally, restoration finishing and polishing will be done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal adaptation	The restoration will be clinically assessed by visual inspection and explorer. Restorations will be given a score using modified USPHS criteria: Alfa: Closely adapted, no visible crevice Bravo: Visible crevice, the explorer will penetrate Charlie: Crevice in which dentin is exposed	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Discoloration	Clinical evaluation by visual inspection and mirror if needed using modified USPHS criteria. Restorations will be given the score: Alfa if No discoloration Bravo if Non penetrating marginal discoloration which can be polished away Charlie if Discoloration with penetration in pulpal direction.	one year
Retention	Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria : Alfa if restoration is retained and there is no loss of restoration. Charlie if loss of restoration.	one year
Secondary caries	Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if no recurrent caries is detected, charlie if recurrent caries is detected. .	one year
surface texture	Clinical evaluation by visual inspection and explorer. Restorations will be given a score according to modified USPHS criteria: Alfa if restoration is enamel-like surface Bravo if Surface rougher than enamel, clinically acceptable Charlie if Surface is unacceptably rough.	one year
postoperative sensitivity	Verbal evaluation by asking the patient. Restorations will be given a score according to modified USPHS criteria: Alfa if not present Bravo if sensitive but diminishing in intensity Charlie if constant sensitivity not diminishing.	one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2021
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 8, 2021
• Last Update Submitted That Met QC Criteria: November 25, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: cons2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Full protocol will be published online in Clinicaltrials.gov to avoid repetition, and keep the integrity of the research work.; Thesis will be discussed and defended in front of a judging committee.; The study will be published to report the results of this clinical trial.
• IPD Sharing Time Frame: 24 months
• IPD Sharing Access Criteria: open access
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

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