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

NCT07007572 | Recruiting Phase 2 DMC

• 1 other identifier: 31-12-24
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Biting Forces; Bone; Change, Diabetic (Manifestation); Color Stability; Disorder of Soft Tissue; Prosthetic Complications; Bacterial Overgrowth

Keywords

biting forces; Bacterial Adhesion; color stability; soft tissue response; prosthetic complication

Outcome Measures

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.

  6 months for each arm

Secondary Outcomes (1)

• Average Maximum Biting Force

  6 months for each arm

Study Arms (2)

patients who receives a screw retained monolithic zirconia bridge

ACTIVE COMPARATOR

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

Combination Product: Digitally-fabricated implant supported supra-structure fabricated from reinforced resin

patients who receives a screw retained resin reinforced bridge

EXPERIMENTAL

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

Combination Product: Digitally-fabricated implant supported supra-structure fabricated from monolithic zirconia

Interventions

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.

patients who receives a screw retained monolithic zirconia bridge

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

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

patients who receives a screw retained resin reinforced bridge

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 12613, Egypt

RECRUITING

Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 12613, Egypt

RECRUITING

Related Publications (6)

• Roh, K.-W. et al. (2019) 'A prospective clinical of lithium disilicate pressed zirconia and monolithic zirconia in posterior implant-supported prostheses: A 24-month follow-up', The Journal of Korean Academy of Prosthodontics, 57(2), p. 134. doi: 10.4047/jkap.2019.57.2.134.

  RESULT

• Nitschke I, Moede C, Hopfenmuller W, Sobotta BAJ, Koenig A, Jockusch J. Validation of a New Measuring Instrument for the Assessment of Bite Force. Diagnostics (Basel). 2023 Nov 21;13(23):3498. doi: 10.3390/diagnostics13233498.

  PMID: 38066739 RESULT

• Liu, Y., Wang, S. and Chen, J. (2023) 'Challenges of monolithic zirconia in implant prosthodontics: Biting forces and maintenance considerations', Journal of Prosthetic Dentistry, 132(1), pp. 75-82. Available at: https://www.journals.elsevier.com/the-journal- of-prosthetic-dentistry.

  RESULT

• Lee, K. H., Patel, M. A. and Smith, A. D. (2023) 'Enhancing function and esthetics in partial edentulism: The role of biomimetic materials', Journal of Prosthetic Dentistry, 130(2), pp. 150-158. Available at: https://www.journals.elsevier.com/the-journal-of-prosthetic- dentistry.

  RESULT

• Gomez, P. H. et al. (2023) 'Advances in resin composites: A review of biomimetic approaches in prosthetic dentistry', Journal of Prosthetic Dentistry. Available at: https://www.journals.elsevier.com/the-journal-of-prosthetic-dentistry.

  RESULT

• Ahmed, N., Patel, A. and Zhang, X. (2024) 'Prosthetic Rehabilitation of Edentulous Patients: A Systematic Review of Complications and Management', International Journal of Prosthodontics, 37(2), pp. 214-223. doi: 10.11607/ijp.7698.

  RESULT

Central Study Contacts

Mahmoud Saleh Fayed, Assistant lecturer

CONTACT

00201141565676; mahmoud.fayed@dentistry.cu.edu.eg

Reham Osman, Professor

CONTACT

rehambosman@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate lecturer- prosthodontics department- faculty of dentistry

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 6, 2025
• Study Start: December 31, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

EG (2)