Computer Guided Placement of Zygomatic Implants in Two Different Approaches

Not Applicable

Recruiting

• Conditions: Atrophic Maxilla; Zygomatic Implants
• Interventions: Procedure: Zygomatic implants

• Registration Number: NCT06129695
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Study Start: 2024-03-04
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer guided intra sinus approach for Zygomatic implant placement.	Zygomatic implants	After reflection of mucoperiosteal flap then the non-working tip of the coarse diamond bur will be inserted till the initial marking point and further preparation of osteotomy site will be performed along the lateral wall of maxillary sinus then sinus membrane will be reflected gently to get easily access for 3.5 mm drill or 4-4.5 mm diameter Zygomatic implant. The surgical stent will be inserted inside the patient's mouth; it will be adapted and held in place by the anchoring screws to Zygoma and osteotomy will progressively widened by using standard 2.9 mm diameter drill and 3.5 mm twist diameter drill. Depth indicator will be used to determine the length of Zygomatic implant. Zygomatic implant will be placed. The platform of Zygomatic implant will be emerged over and close to the top of the crest of the residual alveolar ridge near to first molar region. Closure will done with 3-0 silk suture.
Computer guided extra sinus approach for Zygomatic implant placement.	Zygomatic implants	After adequate exposure of surgical The surgical stent will inserted inside the patient's mouth; it will adapted and held in place by the anchoring screws to Zygoma and osteotomy will progressively widened by using standard 2.9 mm diameter drill and 3.5 mm twist diameter drill. Depth indicator will be used to determine the length of Zygomatic implant. Zygomatic implant that will placed. The platform of Zygomatic implant will be emerged over and close to the top of the crest of the residual alveolar ridge near to first molar region. Closure will done with 3-0 silk suture.

Primary Outcome Measures

Name	Time	Method
Pain by Visual Analogue Scale (VAS)	operation day and first week	1-10

Secondary Outcome Measures

Name	Time	Method
Crestal bone loss around zygomatic implants	after 6 months	To measure the crestal bone loss around Zygomatic implant by CBCT.
Post operative complications	1st week , first month , third month and sixth month	Assessment of the incidence of the postoperative complications in the two groups.

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt