Peri Implant Marginal Bone Height and Bone Density

NCT ID: NCT05974215

Last Updated: 2023-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-07-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Implant Site Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group 1 mandibular implant supported overdenture group 2 mandibular implant supported fixed overdenture
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
each patient was not informed about type of received restoration

Study Groups

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group 1

patients received mandibular implant supported removable overdenture

Group Type ACTIVE_COMPARATOR

assessment of change in bone height by cone beam computed tomography

Intervention Type DEVICE

bone height was measured at 1 ,30 ,90 days after denture insertion

group 2

patients received mandibular implant supported fixed overdenture

Group Type ACTIVE_COMPARATOR

assessment of change in bone height by cone beam computed tomography

Intervention Type DEVICE

bone height was measured at 1 ,30 ,90 days after denture insertion

Interventions

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assessment of change in bone height by cone beam computed tomography

bone height was measured at 1 ,30 ,90 days after denture insertion

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Menatallah Mohamed Elhotieby

OTHER

Sponsor Role lead

Responsible Party

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Menatallah Mohamed Elhotieby

researcher fixed and removable prosthodontics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Menatallah Elhotieby, Researcher

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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1431022023

Identifier Type: -

Identifier Source: org_study_id

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