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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06116877
Other study ID # A03010322
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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