Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture

Prosthesis Durability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116877
• Other study ID #: A03010322
• Status: Completed
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: August 11, 2023

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 11, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

Procedure:
• implant supported overdenture
mandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles

Locations

Country	Name	City	State
Egypt	Mansoura University ,Faculty of dentistry	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

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