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

December 8, 2024 updated by: Noha Taha Kamel Taha Alloush, Al-Azhar University

Radiographic Evaluation of Crestal Bone Changes Around Implants in Patients Treated With Delayed Loaded All on Four (Randomized Clinical Trail)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Nasr City
      • Cairo, Nasr City, Egypt, 4450001
        • Recruiting
        • Al-Azhar University Girls Branch
        • Contact:
        • Contact:
        • Principal Investigator:
          • Noha T Kamel, Lecturer
        • Sub-Investigator:
          • Rehab A Soliman, Lecturer
        • Sub-Investigator:
          • Sara A Elkady, Lecturer
        • Sub-Investigator:
          • Maiada M Awadd, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Height Changes
Time Frame: All records will be taken at time of denture insertion, 6 and 12 months later.
Bone height changes around axially placed anterior implants and distally inclined posterior implants will be evaluated using cone beam CT (CBCT)
All records will be taken at time of denture insertion, 6 and 12 months later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 8, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-PD-24-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and Clinical Study Report

IPD Sharing Time Frame

Start Date: After publication End Date: 10 years

IPD Sharing Access Criteria

After publication through the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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