Dental Caries
Conditions
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.
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.
Interventions
PROCEDUREcervical 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal adaptation | one year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Discoloration | one year | 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. |
| Retention | one year | 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. |
| Secondary caries | one year | 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. . |
| surface texture | one year | 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. |
| postoperative sensitivity | one year | 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. |
Countries
Egypt
Contacts
Primary ContactNourhan K Mohamed, B.D.S
Outcome results
None listed