Effect of Adding Zirconium Oxide Nanoparticles to Printable Implant Overdenture

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT06116877

Collaborator

(none)

Enrollment

Location

Arms

17.3

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Prosthesis Durability	Procedure: implant supported overdenture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 3, 2022

Actual Primary Completion Date :

Apr 1, 2023

Actual Study Completion Date :

Aug 11, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University ,Faculty of dentistry	Mansoura		Egypt	P.O.Box:35516

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mansoura University

ClinicalTrials.gov Identifier:

NCT06116877

Other Study ID Numbers:

A03010322

First Posted:

Nov 3, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prosthesis Failure

Study Results

No Results Posted as of Nov 3, 2023