Reinforced resin versus monolithic zirconia for screw-retained implant prostheses: effects on bone height and biting force
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
This will test whether reinforced resin or monolithic zirconia implant-supported prostheses lead to better marginal bone preservation and biting force in adults needing mandibular screw-retained restorations.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 2 sites (Cairo, Cairo Governorate and 1 other locations) |
| Trial ID | NCT07007572 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional trial compares digitally fabricated screw-retained mandibular implant supra-structures made from biomimetic reinforced resin versus monolithic zirconia. Eligible adults (30–60) with partially edentulous mandibular Class II arches and a fully dentate opposing maxilla will receive one of the two suprastructures and be followed over scheduled visits. Primary outcomes are radiographic marginal bone height changes and intra-oral biting force measurements, with secondary outcomes including prosthetic complications, soft tissue response, color stability, and bacterial adhesion. The trial aims to determine whether a more biomimetic resin material can reduce mechanical complications and improve clinical durability compared with rigid zirconia.
Who should consider this trial
Good fit: Adults aged 30–60 with partially edentulous mandibular Class II arches who require fixed screw-retained implant restorations, have a fully dentate opposing maxilla, healthy mucosa and bone, and no medical contraindications to implant placement.
Not a fit: Patients with Parkinson's disease, xerostomia, allergy to resin or zirconia, active oral inflammation, insufficient bone, medical contraindications to implants, or who smoke more than 10 cigarettes per day are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, reinforced resin prostheses could reduce mechanical failures and maintenance, better preserve surrounding bone, and improve patient comfort and prosthesis longevity.
How similar studies have performed: Monolithic zirconia is widely used and its mechanical limitations are documented, while biomimetic reinforced resin composites are promising but currently have limited long-term clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Age range (30-60 years). * Cooperative patients those are willing to attend all follow-up periods. * Patients with healthy attached mucosa of appropriate thickness free from any inflammation. * Patients with healthy bone of appropriate thickness, width and height free from any inflammation. * Patients without any medical conditions that contraindicates implant placement. Exclusion Criteria: * 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. * Patients smoking more than 10 cigarettes per day. * Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections. * Patients with large irregular bony exostosis. * Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Where this trial is running
Cairo, Cairo Governorate and 1 other locations
- Faculty of Dentistry, Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
- Faculty of Dentistry, Cairo University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud Saleh Fayed, Assistant lecturer
- Email: mahmoud.fayed@dentistry.cu.edu.eg
- Phone: 00201141565676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.