Computer Guided Placement of Zygomatic Implants in Two Different Approaches

Atrophic Maxilla Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129695
• Other study ID #: A.A.D
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Abdulrahman Adnan Aldakka, B.D.S
• Phone: 00201026451243
• Email: abdulrahman.adnan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: November 1, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Atrophic Maxilla
• Atrophy

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Davo R, Malevez C, Rojas J. Immediate function in the atrophic maxilla using zygoma implants: a preliminary study. J Prosthet Dent. 2007 Jun;97(6 Suppl):S44-51. doi: 10.1016/S0022-3913(07)60007-9. Erratum In: J Prosthet Dent. 2008 Mar;99(3):167. — View Citation

Ishak MI, Abdul Kadir MR, Sulaiman E, Abu Kasim NH. Finite element analysis of different surgical approaches in various occlusal loading locations for zygomatic implant placement for the treatment of atrophic maxillae. Int J Oral Maxillofac Surg. 2012 Sep;41(9):1077-89. doi: 10.1016/j.ijom.2012.04.010. Epub 2012 May 9. — View Citation

Jain DK, Pal US, Mohammad S, Mehrotra D, Katrolia R, Shandilya S, Yadav L, Tiwari AK. Comparative evaluation of extrasinus versus intrasinus approach for zygomatic implant placement. J Oral Biol Craniofac Res. 2022 Nov-Dec;12(6):863-872. doi: 10.1016/j.jobcr.2022.08.030. Epub 2022 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain by Visual Analogue Scale (VAS)	1-10	operation day and first week
Secondary	Crestal bone loss around zygomatic implants	To measure the crestal bone loss around Zygomatic implant by CBCT.	after 6 months
Secondary	Post operative complications	Assessment of the incidence of the postoperative complications in the two groups.	1st week , first month , third month and sixth month

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