Clinical trial NCT06151314: Bone Density and Marginal Bone Height Changes Around Dental Implants
Official title: Bone Density and Marginal Bone Height Changes Around Dental Implants Supporting and Retaining Different Types of Prostheses of Mandibular Kennedy Class VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Site Reaction
Keywords: digital milled partial overdenture
Bone density
Fixed bridge
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 18
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: assessment of change of bone density around dental implants
timeFrame: on the first day,on 1 month ,3months
Secondary outcomes:
measure: assessment of change of bone height around dental implants
timeFrame: on the first day,on 1 month ,3months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
city: Giza
country: Egypt
facility: M
Study officials:
affiliation: National Research Centre, Egypt
name: Menatallah M. Elhotieby, Researcher
role: PRINCIPAL_INVESTIGATOR
References: