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NCT05974215 Clinical Trial

Peri Implant Marginal Bone Height and Bone Density

Implant Site Reaction Clinical Trial

Official title:
Peri Implant Marginal Bone Height and Density Supporting Different Prosthesis Restoring Single Edentulous Mandible

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05974215
Other study ID # 1431022023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date July 5, 2023

Study information
Verified date August 2023
Source National Research Centre, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effect of mandibular implant supported removable overdenture on bone height and density and compare it with implant supported fixed overdenture in single mandibular overdenture.

Description:

In this study 10 patients will be selected following inclusion and exclusion criteria. In each group 5 patients (each patient will receive 6 implants) will be divided randomly into two groups. Group I patients will receive mandibular implant supported removable overdenture, while Group II will receive mandibular implant supported fixed overdenture. All patients will be given the usual home care instructions about wearing and caring of dentures and opposing arch. Regarding dentures, removal of them at night and cleaning with denture brush and mild soap will be required. Measurements of Bone height and Bone density will be obtained by using Cone Beam Computed Tomography (CBCT). Measurements will be obtained at denture insertion, after 1 month and after 3 months.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 5, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 50 Years
Eligibility Inclusion Criteria: - Non-smoker Patients - Highly cooperative and motivated patients. - Patients Systemically free from any immunosuppressive diseases. Exclusion Criteria: - Diabetic, hypertensive, cancer patients. - Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions and foreign bodies. - Patients with temporo-mandibular joint disorders and bad oral habits.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• assessment of change in bone height by cone beam computed tomography
bone height was measured at 1 ,30 ,90 days after denture insertion

Locations
Country Name City State
Egypt National Research Centre Cairo

Sponsors (1)
Lead Sponsor Collaborator
Menatallah Mohamed Elhotieby

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary assessment of change of bone height around dental implants bone height was assessed by cone beam computed tomography on the first day, on 30th day, 90th day
Primary assessment of change of bone density around dental implants bone density was assessed by cone beam computed tomography on the first day, on 30th day, 90th day
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