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NCT Number: NCT06151314

Bone Density and Marginal Bone Height Changes Around Dental Implants

The increased benefits to the edentulous population from implant supported overdenture is overwhelming in terms of better quality of life, emotional stability, improved function, enhanced esthetics and clinical comfort.1-6 Implant supported prosthesis is considered a viable option for partially edentulous patients7. The oral rehabilitation of a long anterior mandibular edentulous span with a fixed or removable implant-supported prosthesis using appropriate prostheses have been a target in oral implant research for the last year. The longevity of any implant prosthesis depends on successful osseointegration and implant stability. Cone beam computed tomography (CBCT ) has also been used extensively for the follow-up of dental implants and is considered one of the tools for assessing implant success

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Key information

Conditions

Implant Site Reaction

Age range

40 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre, Cairo, Egypt

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About this study

This study will be conducted on 6 patients having mandibula Kennedy Class VI (anterior edentulous span) Each patient will receive 5 dental implants in the interforaminal area. The patients will be randomly categorized into two groups. According to the final restoration they will receive.

Group I: will receive a digital milled implant supported overdenture. While Group II will receive implant supported fixed bridge.

The marginal bone height changes and bone density around the dental implants will be evaluated at the time of prosthesis insertion, after one and three month.

Research Procedures:

  • Patient selection: will be following inclusion and exclusion criteria.
  • 5 implants will be installed in the interforaminal area for each patient.
  • Digital impression, bite registration, try in and delivery of the final prosthesis for each group will follow the conventional methods.
  • The marginal bone height changes and bone density around the dental implants using CBCT will be evaluated at the time of prosthesis insertion, after one and three month.
  • Statistical analysis: Data will be collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical Package for Social Science (SPSS)® Ver. 24. and Minitab ® statistical software Ver. 16.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • non smokers
  • Patients having long anterior mandibular edentulous span.
  • Highly cooperative and motivated patients.
  • Patients Systemically free from any immunosuppressive diseases.
  • Patients free from Diabetes, Hypertension, Cancer, any mental or physical diseases.
  • Patients not receiving any Radiotherapy or chemotherapy treatment.

Exclusion criteria

-Mandibular arch with thin knife edge, flat or flabby ridge, recent extractions, and foreign bodies.

Treatment and study plan

Dental implants.

Procedure

5 conventional implants measuring from 4 to 5 mm in width and 7 to 10mm in length according to the bone width were inserted in the mandible from right premolar area to left premolar area

Other names: OXY implants

Primary outcomes

  1. assessment of change of bone density around dental implants

    Time frame: on the first day,on 1 month ,3months

    bone density was assessed by cone beam computed tomography

Secondary outcomes

  1. assessment of change of bone height around dental implants

    Time frame: on the first day,on 1 month ,3months

    bone height was assessed by cone beam computed tomography

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

Bone Density and Marginal Bone Height Changes Around Dental Implants Supporting and Retaining Different Types of Prostheses of Mandibular Kennedy Class VI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2023
Registry last updated
Dec 21, 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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