Evaluation of Bone Changes Around Implants in Patients Treated With All on Four

NCT ID: NCT06723678

Last Updated: 2024-12-12

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

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2026-01-01

Brief Summary

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The Goal of the clinical trail is to evaluate the Bone height changes around two axially placed anterior implants and two distally inclined 30-degree angle posterior implants in comparison to two axially placed anterior implants and two distally inclined 45-degree angle posterior implants using cone beam CT (CBCT).

Patients will visit the clinic after the surgery and after the framework and denture insertion for check ups and during the follow up periods ( at denture insertion, 6 months and 12 months)

Detailed Description

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All patients will receive upper complete dentures and mandibular All on-4 screw-retained prosthesis. The upper complete denture will be mucosa supported and the lower will be All on-4 screw-retained prosthesis. Patients will be divided into two equal groups; Group I will receive two axially placed anterior implants and two distally inclined 30-degree angle posterior implants, while Group II will receive two axially placed anterior implants and two distally inclined 45-degree angle posterior implants.

Both groups will be functionally loaded after three months of insertion. Bone height changes around axial and distally inclined implants will be evaluated using cone beam CT (CBCT), All records will be taken at time of denture insertion, 6 and 12 months later.

Conditions

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Edentulous Alveolar Ridge In Mandible Complete Edentulism All on Four Technique Dental Implant Edentulous Jaws Edentulous Mouth

Keywords

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Completely edentulous patients Dental Implants All on four technique Fixed Detachable Prosthesis screw retained prosthesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Two distally inclined 45-degree angle posterior implants.

During the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants.

Group Type EXPERIMENTAL

Two distally inclined 45-degree angle posterior implants

Intervention Type PROCEDURE

During the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients.

Two distally inclined 30-degree angle posterior implants.

During the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants.

Group Type ACTIVE_COMPARATOR

Two distally inclined 30-degree angle posterior implants

Intervention Type PROCEDURE

During the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients

Interventions

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Two distally inclined 45-degree angle posterior implants

During the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients.

Intervention Type PROCEDURE

Two distally inclined 30-degree angle posterior implants

During the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients' ages must range from 50-65 years old.
* All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
* Patients should be free from any metabolic or bone disorders that contraindicate implant installation.
* All patients must have sufficient inter arch space

Exclusion Criteria

* Patients with oral or systemic diseases.
* Patients with xerostomia or excessive salivation.
* Patients with parafunctional habits (bruxism or clenching).
* Heavy smoker or alcoholic patients.
* Patients with history of temporo-mandibular dysfunction.
* Patients with brain disorders or psychiatric disorders
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Noha Taha Kamel Taha Alloush

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University Girls Branch

Cairo, Nasr City, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Noha T Kamel, Lecturer

Role: CONTACT

Phone: +201112295457

Email: [email protected]

Rehab A Soliman, Lecturer

Role: CONTACT

Phone: +201023235360

Email: [email protected]

Facility Contacts

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Noha T Kamel, lecturer

Role: primary

Rehab A Soliman, Lecturer

Role: backup

Other Identifiers

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P-PD-24-28

Identifier Type: -

Identifier Source: org_study_id