Clinical trial NCT05149209: Evaluation of a New Bioactive Material Versus a Fluoride-Releasing Hybrid Restorative Material in Cervical Lesions
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Marginal adaptation
timeFrame: one year
Secondary outcomes:
measure: Marginal Discoloration
timeFrame: one year
measure: Retention
timeFrame: one year
measure: Secondary caries
timeFrame: one year
measure: surface texture
timeFrame: one year
measure: postoperative sensitivity
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nourhan Khaled Mohamed Samir
state: Maadi
Study officials:
References: