Evaluation Of Marginal Bone Height Changes And Biting Force In Screw Retained Implant Prostheses Using Reinforced Resin Vs Monolithic Zirconium

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-60
SponsorCairo University

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Digitally-fabricated implant supported supra-structure fabricated from reinforced resin

    Combination product

    A 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 product

    Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: patients who receives a screw retained monolithic zirconia bridgeActive comparator 1 intervention
Group B: patients who receives a screw retained resin reinforced bridgeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months for each arm

Secondary outcomes

1

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.

Time frame
6 months for each arm

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.