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
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 |
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
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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
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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