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OpenTrials
Completed

NCT Number: NCT06129695

Computer Guided Placement of Zygomatic Implants in Two Different Approaches

Evaluation of computer guided placement of Zygomatic implants utilizing intra sinus versus extra sinus surgical approach for the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable approach for Zygomatic implant placement with the least postoperative complications

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, 12311, Egypt

About this study

During the last ten years, there has been an increase in the number of edentulous patients looking for and seeking out rehabilitation. Formerly, individuals with edentulous maxilla and mandibles were rehabilitated with removable complete dentures, but it was associated with poor patients' satisfaction.

Alveolar bone atrophy results from loss of bony support due to the physiological process that naturally takes place after tooth loss, especially in the upper arch. Due to its shape and structure, the maxilla is an extremely challenging arch to reconstruct with dental implants.

Oral and Maxillofacial surgeons began utilizing alternative methods to replace missing teeth with osseointegrated dental implants in atrophic maxilla. As a result, different methods were developed for handling of this issue, including tilted implants, sinus elevation, the use of Pterygoid implants, the use of short implants and Zygomatic implants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
  • Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
  • Lacking posterior maxillary bone support due to significant sinus pneumatistion
  • Good systemic health (ASA score I-II)
  • Highly motivated patients.

Exclusion criteria

  • Patient not willing to give his/her informed consent.
  • Patients with systemic disease that did not permit the surgical procedure (including general anaesthesia).
  • Patients with uncontrolled diabetes or under bisphosphonate therapy.
  • Heavy smoker.(> 20 cigarettes daily)
  • Patient with psychiatric problems, severe bruxism or other parafunctional habits.
  • Acute sinusitis.
  • Malignancy or pathology in Maxilla or Zygoma.

Treatment and study plan

Zygomatic implants

Procedure

the ideal way to support implant-based restorative procedures for full and partially edentulous patients who are missing bone in the upper posterior maxilla.

Primary outcomes

  1. Pain by Visual Analogue Scale (VAS)

    Time frame: operation day and first week

    1-10

Secondary outcomes

  1. Crestal bone loss around zygomatic implants

    Time frame: after 6 months

    To measure the crestal bone loss around Zygomatic implant by CBCT.

  2. Post operative complications

    Time frame: 1st week , first month , third month and sixth month

    Assessment of the incidence of the postoperative complications in the two groups.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Computer Guided Placement of Zygomatic Implants for Reconstruction of Atrophic Maxilla Utilizing Two Different Approaches: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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