About this trial
This studies aims to compare the behavior of recently introduced resin reinforces compared to monolithic zirconia
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mandibular Class II, partially edentulous patients that enables measuring the marginal bone height changes and values of biting forces intra-orally.
Fully dentulous edentulous opposing Maxillary arch.
Patients with normal class I jaw relationship.
Patients that require fixed restorations for functional and esthetic reasons
Disqualifiers
Patients with Parkinson's disease
Patients with xerostomia.
Patients with a history of allergy to resins and/ or zirconia.
Patients with a medical systematic condition that contraindicate implant placement.
Trial design
Crossover
Treatments tested in this trial
Digitally-fabricated implant supported supra-structure fabricated from reinforced resin
Combination productA comprehensive clinical examination with an understanding of patients' chief complaints and needs will be carried out. For each patient, two implants will be placed in the edentulous area, and the patient will receive a screw-retained bridge supported by both implants made of milled monolithic zirconia (Dental Direkt Zirconia, Germany). After 6 months, the zirconia restoration will be replaced with a milled resin-reinforced composite (Nanoska G Plus, USA), allowing the same patient to use the new restoration for another 6 months. Randomization will be performed to determine the sequence of bridge material for each participant. Accordingly, the two restorations will be sequentially delivered to each participant with no gap (wash-up period) between them. Consent will be signed by the selected participants after explaining the detailed information of the trial.
Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia
Combination productDigitally-fabricated implant supported supra-structure fabricated from monolithic zirconia
Treatment groups
Trial outcomes
Primary outcomes
Measurement of the Bone height changes (bone level)
Change in marginal bone height (in millimeters) measured using long cone parallel peri-apical radiographs at baseline and 6 months for each prosthetic material phase (monolithic zirconia and resin-reinforced). Radiographs will be taken at four time points: Start of phase 1 (zirconia, baseline) End of phase 1 (zirconia, 6 months) Start of phase 2 (resin-reinforced, baseline) End of phase 2 (resin-reinforced, 6 months) Bone level will be assessed on the mesial and distal surfaces of each implant using a standardized radiographic protocol.
Secondary outcomes
Average Maximum Biting Force
Average maximum static biting force (in Newtons) recorded using an occlusal force meter. For each prosthetic material phase (monolithic zirconia and resin-reinforced), patients will bite on the sensor five times per side. The average value from the intervention side (restored side) will be compared with that of the intact side. Measurements will be taken after prosthetic delivery for both phases and compared using statistical analysis to assess relative performance. Time Points: After placement of zirconia prosthesis After placement of resin-reinforced prosthesis Tool Used: Occlusal force meter with digital sensor, positioned on molars of both the intact and intervention sides.
Sponsors and contacts
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