Trials / Recruiting

RecruitingNCT07007572

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

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 14 (estimated)

Sponsor: Cairo University · Academic / Other
Sex: All
Age: 30 Years – 60 Years
Healthy volunteers: Accepted

Summary

This studies aims to compare the behavior of recently introduced resin reinforces compared to monolithic zirconia

Detailed description

The clinical success of implant-supported prostheses is significantly influenced by the material used, as it directly affects both prosthetic longevity and patient satisfaction. Monolithic zirconia, despite its widespread popularity, presents notable clinical challenges. Its excessive rigidity often leads to mechanical failures such as chipping, fractures, and increased wear of the opposing dentition. Moreover, zirconia's limited ability to absorb and dissipate occlusal forces can result in elevated stresses on implant components, contributing to screw loosening or fractures and necessitating frequent maintenance interventions. These complications not only escalate the overall cost of care but also negatively impact patient outcomes, leading to discomfort, inconvenience, and dissatisfaction. Consequently, there is a pressing need to explore alternative restorative materials that maintain strength and esthetic appeal while mitigating these clinical issues. Biomimetic reinforced resin composites, engineered to emulate the mechanical behavior of natural tooth structures, offer a promising solution. By more effectively absorbing and distributing occlusal forces, these materials may reduce stress on both prostheses and surrounding tissues. If clinically validated, biomimetic resins could lead to fewer mechanical complications, improved bone preservation, and enhanced overall durability of implant-supported prostheses. The clinical implications of adopting biomimetic reinforced resin are substantial; a material that reduces the frequency of repairs and replacements compared to monolithic zirconia would mark a significant advancement in prosthetic dentistry, offering clinicians a superior restorative option and improving patient satisfaction through more stable, long-term outcomes. To investigate this, mandibular Class II partially edentulous patients will be recruited from the outpatient clinic at the Department of Prosthodontics, Cairo University, based on specific inclusion criteria. After obtaining informed consent and conducting a comprehensive clinical examination, each patient will receive two implants in the edentulous area, restored initially with a screw-retained bridge made of milled monolithic zirconia. After six months, the zirconia bridge will be replaced with a milled resin-reinforced composite bridge. The sequence of material placement will be randomized for each participant, ensuring that each patient uses both materials sequentially without a washout period. Intraoral scans and digital bite registrations will be performed, and prostheses will be designed using CAD software. Fabrication will follow standardized milling techniques for both zirconia and resin-reinforced composite materials. Bone levels around the implants will be evaluated using long cone parallel periapical radiographs, with measurements recorded at 0 and 6 months during each material phase. This approach allows for direct comparison of the two materials' effects on peri-implant bone health. Biting forces will also be assessed using an occlusal force meter. A reference bite force will be measured on the intact side, followed by measurements on the intervention side after the placement of each restorative material. Each measurement will be repeated five times and averaged to ensure accuracy. All data regarding bone levels and biting forces will be recorded, tabulated, and statistically analyzed in the presence of an outcome assessor during clinical visits. Through this study design, it will be possible to evaluate the mechanical and biological performance of monolithic zirconia versus biomimetic reinforced resin composites in implant-supported prostheses.

Conditions

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Digitally-fabricated implant supported supra-structure fabricated from reinforced resin	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.
COMBINATION_PRODUCT	Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia	Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia

Timeline

Start date: 2024-12-31
Primary completion: 2026-01-01
Completion: 2026-03-01
First posted: 2025-06-06
Last updated: 2025-06-06

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07007572. Inclusion in this directory is not an endorsement.