Bone Density and Marginal Bone Height Changes Around Dental Implants

Implant Site Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06151314
• Other study ID #: National Research Centre
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 5, 2023

Study information

• Verified date: December 2023
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 5, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Implant Site Reaction

Intervention

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

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo
Egypt	M	Giza

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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