Bone Density and Marginal Bone Height Changes Around Dental Implants

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

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

Study Overview

• Status: Completed
• Conditions: Implant Site Reaction
• Intervention / Treatment: Procedure: Dental implants.

Detailed Description

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:

1. Patient selection: will be following inclusion and exclusion criteria.
2. 5 implants will be installed in the interforaminal area for each patient.
3. Digital impression, bite registration, try in and delivery of the final prosthesis for each group will follow the conventional methods.
4. 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.
5. 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12622
    • National Research Centre
  • Giza, Egypt, +20
    • M

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "digital milled implant supported removable partial overdenture; patients received digital milled implant supported removable partial overdenture.	Procedure: Dental implants.; 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
Active Comparator: "implant supported fixed bridge"; patients received an implant supported fixed bridge	Procedure: Dental implants.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of change of bone density around dental implants	bone density was assessed by cone beam computed tomography	on the first day,on 1 month ,3months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of change of bone height around dental implants	bone height was assessed by cone beam computed tomography	on the first day,on 1 month ,3months

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Investigators: Principal Investigator: Menatallah M. Elhotieby, Researcher, National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 5, 2023

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bone density; digital milled partial overdenture; Fixed bridge
• Other Study ID Numbers: National Research Centre

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No