Peri Implant Marginal Bone Height and Bone Density

August 6, 2023 updated by: Menatallah Mohamed Elhotieby

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12622
        • National Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group 1
patients received mandibular implant supported removable overdenture
Device: assessment of change in bone height by cone beam computed tomography
bone height was measured at 1 ,30 ,90 days after denture insertion
Active Comparator: group 2
patients received mandibular implant supported fixed overdenture
Device: assessment of change in bone height by cone beam computed tomography
bone height was measured at 1 ,30 ,90 days after denture insertion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menatallah Mohamed Elhotieby

Investigators

  • Principal Investigator: Menatallah Elhotieby, Researcher, National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1431022023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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