Transforming Channel Osteotomy Into Tunnel Osteotomy in Zygomatic Implant Preparation

NCT07394179 | Not Yet Recruiting DMC

• 1 other identifier: Grafting with zygoma implants
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The evolution of zygomatic implant techniques, from the original procedures to the Zygomatic Anatomy-Guided Approach (ZAGA), has significantly improved outcomes for patients with severe maxillary atrophy. Despite these advancements, challenges such as peri-implant tissue recession, sinus complications, and aesthetic concerns persist. Bone augmentation and soft tissue enhancement techniques, including sinus lifts, connective tissue grafts, and buccal fat pad utilization, have been employed to address these issues with varying degrees of success. However, the need for predictable and stable bone regeneration and soft tissue contouring remains critical for long-term implant success. The following study aims to assess bone gain, soft tissue contour, and stability after using bone lamina shell, providing a potential solution to enhance peri-implant tissue integrity and optimize functional and aesthetic outcomes in zygomatic implant rehabilitation

Conditions

Zygomatic Implants

Keywords

Zygomatic implants; Grafting; Tunnel and channel

Outcome Measures

Primary Outcomes (1)

• 1-soft tissue thickness 2-Soft tissue recession

  For soft tissue recession, a clinical visual exploration was performed, and defects were measured through a periodontal probe from fixed reference point (buccal surface of implant platform). For soft tissue thickness, a clinical method by using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe

  6 months of healing

Secondary Outcomes (1)

• Bone gain

  6 months of healing

Study Arms (2)

group A

ACTIVE COMPARATOR

Zygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy.

Procedure: Group A

group B

PLACEBO COMPARATOR

Zygomatic implants placed in Channel shape osteotomy with only soft tissue augmentation by using buccal bad of fat.

Procedure: Group B

Interventions

Group B PROCEDURE

after zygomatic implant placed with channel shape osteotomy ,Blunt dissection to buccal space to extract buccal pad of fat which will be mobilized and advanced to cover buccal surface of zygomatic implants and fixed over it with either suturing to palatal mucosa or with bone tacs

group B

Group A PROCEDURE

after zygomatic implant placed with channel shape osteotomy,Wetting, trimming and fixation of xenogenic lamina shell buccal to placed zygomatic implants in combination with xenogenic particulate form to fill all gaps between lamina from one side and native bone and implant from other side

group A

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 21 years. 2. Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 5mm in height, in the area immediately distal to the canine pillar) 3. Patients with at least more than half of the zygomatic implant platform diameter inside the alveolar bone crest.

You may not qualify if:

• Patients with systemic conditions contra-indicating general anesthesia. 2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
• \. Patients with acute maxillary sinus infection or maxillary sinus cyst. 4. Restricted mouth opening (less than 3cm inter-arch distance anteriorly).

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, 63514, Egypt

Location

Central Study Contacts

Hiatham Ahmed El maergy, Doctor

CONTACT

+201272251119; ha3591@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

EG (1)