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Completed

NCT Number: NCT05974215

Peri Implant Marginal Bone Height and Bone Density

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.

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Key information

Conditions

Implant Site Reaction

Age range

40 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, 12622, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

assessment of change in bone height by cone beam computed tomography

Device

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Menatallah Mohamed Elhotieby

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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