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Bone Density and Marginal Bone Height Changes Around Dental Implants

NCT ID: NCT06151314

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-05

Brief Summary

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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

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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.

Conditions

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Implant Site Reaction

Keywords

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digital milled partial overdenture Bone density Fixed bridge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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"digital milled implant supported removable partial overdenture

patients received digital milled implant supported removable partial overdenture.

Group Type ACTIVE_COMPARATOR

Dental implants.

Intervention Type 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

"implant supported fixed bridge"

patients received an implant supported fixed bridge

Group Type ACTIVE_COMPARATOR

Dental implants.

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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OXY implants

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Menatallah Mohamed Elhotieby

researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Menatallah M. Elhotieby, Researcher

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, , Egypt

Site Status

M

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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National Research Centre

Identifier Type: -

Identifier Source: org_study_id