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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06129695
Other study ID # A.A.D
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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Active, not recruiting NCT05400044 - Assessment of Bone Quality and Quantity for Three Dimensional Bone Augmentation for Maxilla Using Patient Specific Titanium Meshes Loaded With Bone Marrow Aspirate Mixed With Xenograft Versus Xenograft Mixed With Autografts Only: a Randomized Clinical Trial N/A
Completed NCT03268512 - Effect of L-PRF and A-PRF in Ridge Preservation N/A

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