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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
a)Inclusion Criteria of participants:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nourhan K Mohamed, B.D.S | Contact | 01003787886 | nourhankhaled@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nourhan Khaled Mohamed Samir | Cairo | Maadi | 11728 | Egypt |
24 months
open access
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.
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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.
|
| 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 |