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

NCT05149209 | Unknown DMC

• 1 other identifier: cons2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Marginal Discoloration

  one year

• Retention

  one year

• Secondary caries

  one year

• surface texture

  one year

• postoperative sensitivity

  one year

Study Arms (2)

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

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

cervical restoration PROCEDURE

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.

Fluoride, calcium and phosphate-releasing new bioactive material (Activa™ Presto, Pulpdent®, USA).; Fluoride-releasing hybrid restorative material (Giomer, Shofu, Japan).

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female gender.
• Only co-operative patients will be approved to participate in the trial.
• Medically free adult patients.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Nourhan Khaled Mohamed Samir

Cairo, Maadi, 11728, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Nourhan K Mohamed, B.D.S

CONTACT

01003787886; nourhankhaled@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants will be blinded to the technique used since the patient will attend the same number of visits and he can not differentiate between different restorative materials. The operator cannot be blinded because of the difference in the application procedures of each restorative material. The outcome assessor will be blinded to the material used. This will be performed by M.S. and Y.H. Therefore the assessors mustn't be included in the preclinical assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Conservative department

Model Details: Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 30, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 24 months
• Access Criteria: open access

Locations

EG (1)