Completely Versus Partially Guided Zygomatic Implant

NCT06227351 | Completed

• 1 other identifier: Zygomatic Implant
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is evaluation of accuracy of completely versus partially limiting computer generated surgical three-dimensional guides during placement of zygoma implants in patients with atrophic maxillae.

Conditions

Maxillary Deficiency; Alveolar Bone Loss

Keywords

zygomatic implant; guided surgery; deficient maxilla

Outcome Measures

Primary Outcomes (1)

• Implant position

  Comparing the position of implant post-operatively with the virtual planning pre-operatively.

  one week after the surgery.

Secondary Outcomes (1)

• Surgery duration

  from the start of surgery to the completion of surgery.

Study Arms (2)

completely limiting computer generated surgical three-dimensional guide

ACTIVE COMPARATOR

patients in this group will receive zygomatic implant placed in a completely fully guided technique using surgical guide,keys and sleeves.

Procedure: completely limiting computer generated surgical three-dimensional guide

Partially limiting computer generated surgical three-dimensional guide

ACTIVE COMPARATOR

patients in this group will receive zygomatic implant placed in a partially guided technique using surgical guide.The first drill only will be used with the guide then the guide will be removed and the whole procedure with the remaining drills will be completed in a free hand technique.

Procedure: Partially limiting computer generated surgical three-dimensional guide

Interventions

completely limiting computer generated surgical three-dimensional guide PROCEDURE

Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full thickness flap to expose the maxilla up to the fronto-zygomatic notch. According to the zygoma anatomy-guided approach classification and previously planned surgery using Cone beam C.T lateral window and sinus foor lifting will be decided to be done or not. After securing the surgical templates in its proper position, sequential osteotomy drilling will be performed in a steady in and out movement under copious sterile saline irrigation.The drills will be entering the maxilla palatally and puncturing the alveolar crest to reach the buccal side.The drills will be visualized through the bony window created until it reaches the zygomatic bone.Sequential drills with the uses of guided tubes,sleeves and keys will be used to guarantee that the implant have been placed in a fully completely guided manner.Afterwards the zygomatic implants will be placed.

completely limiting computer generated surgical three-dimensional guide

Partially limiting computer generated surgical three-dimensional guide PROCEDURE

Long mid-crestal incision from the right to the left maxillary tuberosity and raising a full -thickness flap to expose the maxilla up to the fronto-zygomatic notch. According to zygoma anatomy-guided approach classification and previously planned surgery using cone beam C.T.lateral window and sinus floor lifting will be decided to be done or not.After securing the surgical templates,The first drill only will be used using the guide then it will be removed and the other drills will be completed in a free hand without the use of guide to guarantee that the implant will be placed in partially guided manner.Afterwards the zygomatic implants will be placed.

Partially limiting computer generated surgical three-dimensional guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years.
• Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 4 mm in height, in the area immediately distal to the canine pillar).

You may not qualify if:

• Patients with systemic conditions contra-indicating general anesthesia.
• Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
• Patients with acute maxillary sinus infection or maxillary sinus cyst.
• Restricted mouth opening (less than 3 cm inter-arch distance anteriorly).

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum university

Al Fayyum, 63514, Egypt

Location

MeSH Terms

Conditions

Retrognathia; Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Resorption; Bone Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant in the Department of Oral and Maxillofacial Surgery

Model Details: This is a prospective randomized (1:1) clinical trial study formed of 2 competitive groups where 12 implants will be placed in 2 groups (6 for each group) to compare the accuracy of completely limiting computer generated surgical three-dimensional guide versus partially limiting computer generated surgical three-dimensional guide during placement of zygomatic implants in patients with atrophic maxillae.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: February 5, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)