Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture

Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture Acrylic Resin Base Material. Clinical Comparative Study

This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants

Study Overview

• Status: Completed
• Conditions: Prosthesis Durability
• Intervention / Treatment: Procedure: implant supported overdenture

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, P.O.Box:35516
    • Mansoura University ,Faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This will be achieved through medical history and clinical examination by physician.

  2. They will have completely edentulous jaws for at least 1 year. 3. They will be of angle's class I maxillo-mandibular relationship and have upper and lower completely edentulous arches.

  4. Residual alveolar ridges covered with healthy firm mucosa. 5. All included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone.

Exclusion Criteria:

• Patients with chronic systemic diseases that affect bone metabolism
• Uncontrolled diabetic patients
• Patients with TMJ dysfunction
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (I) non modified; Five patients will receive mandibular 2-implant retained overdentures of non-modified printable acrylic resin base material.	Procedure: implant supported overdenture; mandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles
Active Comparator: Group (II) modified; Five patients will receive mandibular 2-implant retained overdentures of modified printable acrylate resin base material with zirconium oxide nanoparticles.	Procedure: implant supported overdenture; mandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface roughness	Surface roughness: will be evaluated using profilometer device	one year
Microbiological assessment	Microbiological assessment of denture base surface microbiological analysis	one year
Peri-implant soft tissue health	was evaluated using scores for plaque and gingival bleeding	one year

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Estimated): November 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: A03010322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No