Computer Guided Placement of Zygomatic Implants in Two Different Approaches

NCT06129695 | Recruiting

• 1 other identifier: A.A.D
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Atrophic Maxilla; Zygomatic Implants

Keywords

Zygoamtic implants, Dental implants, Atrophic maxilla, Intra sinus, Extra sinus and Full mouth rehabilitation

Outcome Measures

Primary Outcomes (1)

• Pain by Visual Analogue Scale (VAS)

  1-10

  operation day and first week

Secondary Outcomes (2)

• Crestal bone loss around zygomatic implants

  after 6 months

• Post operative complications

  1st week , first month , third month and sixth month

Study Arms (2)

Computer guided intra sinus approach for Zygomatic implant placement.

EXPERIMENTAL

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.

Procedure: Zygomatic implants

Computer guided extra sinus approach for Zygomatic implant placement.

ACTIVE COMPARATOR

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.

Procedure: Zygomatic implants

Interventions

Zygomatic implants PROCEDURE

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

Computer guided extra sinus approach for Zygomatic implant placement.; Computer guided intra sinus approach for Zygomatic implant placement.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 12311, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 22575179 BACKGROUND

• 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.

  PMID: 17618933 BACKGROUND

• 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.

  PMID: 36212616 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Central Study Contacts

Abdulrahman Adnan Aldakka, B.D.S

CONTACT

00201026451243; abdulrahman.adnan@dentistry.cu.edu.eg

Ramy Ragab El-Beialy, PhD

CONTACT

ramy.elbeialy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each patient will be given a code by the researcher and the observers will be blind to which group this case belong. Patients, radiographic outcome assessor and statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree candidate

Model Details: 1. Randomized Controlled Clinical Trial. 2. Parallel group study. 3. Allocation Ratio 1:1.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: March 4, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 1, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

EG (1)