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

NCT06723678 | Recruiting DMC

• 1 other identifier: P-PD-24-28
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bone Height Changes

  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.

Study Arms (2)

Two distally inclined 45-degree angle posterior implants.

EXPERIMENTAL

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

Two distally inclined 30-degree angle posterior implants.

ACTIVE COMPARATOR

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

Interventions

Two distally inclined 45-degree angle posterior implants 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 45-degree angle posterior implants.

Two distally inclined 30-degree angle posterior implants 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

Two distally inclined 30-degree angle posterior implants.

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Girls Branch

Cairo, Nasr City, 4450001, Egypt

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous; Mouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases

Central Study Contacts

Noha T Kamel, Lecturer

CONTACT

+201112295457; yunie0959@gmail.com

Rehab A Soliman, Lecturer

CONTACT

+201023235360; rehab.abdallah@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: November 26, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start Date: After publication End Date: 10 years
• Access Criteria: After publication through the corresponding author

Locations

EG (1)