Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
NCT ID: NCT05149209
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-12-15
2022-12-30
Brief Summary
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* The clinical evaluation will be done using modified USPHS criteria at baseline,3,6,9 and 12 months.
Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Nourhan Khaled Mohamed Samir
Resident at Conservative department
Locations
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Nourhan Khaled Mohamed Samir
Cairo, Maadi, Egypt
Countries
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Central Contacts
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Facility Contacts
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Nourhan K Mohamed, B.D.S.
Role: primary
Other Identifiers
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cons2021
Identifier Type: -
Identifier Source: org_study_id