Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 30 to 60

Reinforced resin versus monolithic zirconia for screw-retained implant prostheses: effects on bone height and biting force

Official title: 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

Run by Cairo University · NCT07007572 · Data updated 2026-11-12

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.

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Quick facts

PhasePhase 2
Study typeInterventional
Ages30 Years to 60 Years
SexAll
Enrollment14 (estimated)
SponsorCairo University
Academic / other
Locations2 sites (Cairo, Cairo Governorate and 1 other locations)
StatusRecruiting
StartedDecember 31, 2024
Main results expectedJanuary 1, 2026
Study endsMarch 1, 2026
Registry record updatedJune 6, 2025
Trial IDNCT07007572 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Faculty of Dentistry, Cairo University
    Cairo, Cairo Governorate, Egypt
    Recruiting
  • Faculty of Dentistry, Cairo University
    Cairo, Cairo Governorate, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.