Clinical trial NCT06129695: Computer Guided Placement of Zygomatic Implants in Two Different Approaches
Official title: Evaluation of Computer Guided Placement of Zygomatic Implants for Reconstruction of Atrophic Maxilla Utilizing Two Different Approaches: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophic Maxilla
Zygomatic Implants
Keywords: Zygoamtic implants, Dental implants, Atrophic maxilla, Intra sinus, Extra sinus and Full mouth rehabilitation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Randomized Controlled Clinical Trial.
2. Parallel group study.
3. Allocation Ratio 1:1.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain by Visual Analogue Scale (VAS)
timeFrame: operation day and first week
Secondary outcomes:
measure: Crestal bone loss around zygomatic implants
timeFrame: after 6 months
measure: Post operative complications
timeFrame: 1st week , first month , third month and sixth month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
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.
citation: 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.
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.