Bone Density and Marginal Bone Height Changes Around Dental Implants

• Sponsor: National Research Centre, Egypt (Other)
• Overall Status: Completed
• CT.gov ID: NCT06151314
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site: 9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Implant Site Reaction	Device: implant supported removable partial overdenture	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Bone Density and Marginal Bone Height Changes Around Dental Implants Supporting and Retaining Different Types of Prostheses of Mandibular Kennedy Class VI
• Actual Study Start Date: Jan 1, 2023
• Actual Primary Completion Date: Apr 1, 2023
• Actual Study Completion Date: May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I patients received digital milled implant supported removable partial overdenture	Device: implant supported removable partial overdenture; implant supported fixed bridge
Active Comparator: Group II patients received digital milled implant supported fixed bridge	Device: implant supported removable partial overdenture; implant supported fixed bridge

Outcome Measures

Primary Outcome Measures

1. assessment of change of bone density around dental implants [on the first day,on 1 month ,3months]

   bone density was assessed by cone beam computed tomography

Secondary Outcome Measures

1. assessment of change of bone height around dental implants [on the first day,on 1 month ,3months]

   bone height was assessed by cone beam computed tomography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Research Centre	Cairo		Egypt	12622
2	M	Giza		Egypt	+20

Sponsors and Collaborators

• National Research Centre, Egypt

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Menatallah Mohamed Elhotieby, researcher, National Research Centre, Egypt
• ClinicalTrials.gov Identifier: NCT06151314
• Other Study ID Numbers: National Research Centre
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Menatallah Mohamed Elhotieby, researcher, National Research Centre, Egypt: digital milled partial overdenture; Bone density; Fixed bridge

Study Results

No Results Posted as of Nov 30, 2023