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Zygomatic ImplantsNCT07394179

Transforming Channel Osteotomy Into Tunnel Osteotomy in Zygomatic Implant Preparation

A study testing Group A and Group B in people with Zygomatic Implants, run by Fayoum University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Zygomatic Implants
What is being tested?
Group A and Group B
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteEgypt
Study dates
1 Feb 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1 -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.

Who cannot join

  • 1 - 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).
  • 3. Patients with acute maxillary sinus infection or maxillary sinus cyst. 4. Restricted mouth opening (less than 3cm inter-arch distance anteriorly).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hiatham Ahmed El maergy, Doctor contact

+201272251119

ha3591@fayoum.edu.eg

Egypt1 site
  • Fayoum University

    Al Fayyum, 63514

    Arfa Sabry Gomma, Professor, +20842114095, ash02@fayoum.edu.eg

Other trials in Egypt

About this study

Official title: Transforming Channel Shape Osteotomy Into Tunnel Shape Osteotomy for Zygomatic Implant. A Randomized Control Trial

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

Read the detailed description

The term "tunnel osteotomy" is used because the alveolar osseous entry point has a floor, lateral walls, and a more or less complete roof. When a tunnel osteotomy was chosen, the sinus membrane was perforated at the time of completion of the antrostomy. The objective was to achieve osseointegration at the neck level also to seal the sinus entrance in the long-term using: (1) a stable zygomatic implant with (2) a suitable threaded neck section (3) bordered by enough bone at the coronal entry, (4) stabilized by adequate apical zygomatic anchorage; and (5) connected to a rigid prosthesis that provides adequate masticatory load distribution. The "tunnel osteotomy" was also employed in ZAGA Type 3 cases when the alveolar bone adopts a triangular, buccally inclined, profile and the maxillary anterior wall was concave(23).

When inadequate residual bone architecture at the crestal level (less than 4 mm of thickness) was measured, the coronal osteotomy was buccally shifted to prevent future sinus or nasal-oral communication/fistula. Implant beds were designed to be carved as much as possible into both the buccal alveolar and maxillary wall bone with the limits of sinus lining integrity. This osteotomy type is known as a "channel osteotomy" and is noted when lateral walls and floor are present but with no roof(23).

On analyzing the evolution of the abovementioned technique (ZAGA), it is seen that the position of the neck of the zygomatic implants has been mobilized laterally from an intrasinus position to an extrasinus position. Different anterior techniques have thus sought to avoid maxillary sinus complications(19,24,25). However, hard and soft tissue infective and aesthetic complications (exposure of the implant threads) were detected(26-28).

Peri-implant hard and soft tissues are crucial for avoiding complications around conventional implants. Two aspects have been studied in this regard: buccal cortical bone and the thickness and width of the peri-implant keratinized mucosa. On the one hand, a recent systematic review has reported that a buccal cortical thickness of close to 2 mm was associated with less vertical bone resorption and less mucosal recession(29).

On the other hand, the presence of sufficient keratinized mucosa thickness exerts a protective effect against marginal bone loss(30,31). These abovementioned concepts to minimum necessary peri-implant tissues could be extrapolated to zygomatic implants. A number of techniques for bone and soft tissue enhancement around zygomatic implants have been described, with high success rates.

Regarding bone regeneration, a sinus lift during the zygomatic implant placement has been proposed (32). Regarding soft tissue enhancement, dissection of the buccal fat pad and the ZAGA "Scarf Graft" (pediculate connective tissue grafting [26]) have been utilized to prevent buccal mucosal recession(33). Chow et al. described a simultaneous sinus lift for reducing oroantral communications and subsequent maxillary sinus infections in zygomatic implants(34).

Hinze et al. with Chow's technique described an increase in peri-implant bone around the coronal part of the implant (buccal bone 1.4 ± 0.5 mm and palatal bone 4.3 ± 0.4 mm) at 6 months which same results of Peñarrocha et al study showed similar bone gained width(34,35).

Peri-implant bone defects or thin buccal/palatal corticals were regenerated with a mixture of particulate synthetic bone graft (beta-phosphate tricalcium (KeraOs ®, Keramat, Spain)) with autogenous bone and resorbable collagen membranes (Creos Xenoprotect ®, Nobel Biocare, Sweden) fixed with surgical pins (Meisinger ®, Sanhigia, Spain). Management of the soft tissue without flap pressure was achieved through two-plane suturing (horizontal double and simple stitches). Bone regeneration was performed palatal, buccal or palatal and buccal(35).

Palatal rotated connective tissue flaps or free connective tissue grafts were performed to improve buccal soft tissues around the zygomatic implants. Palatal rotated flaps were fixed buccally to the zygomatic implants using resorbable sutures through small perforations created in the bone alveolar crest mesial and distal of the zygomatic implant. Free connective tissue grafts were collected from the palatal flap and fixed buccally around the coronal part of the zygomatic implants by two surgical pins(35).

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.

PICOTS Population: people with atrophic maxilla. Intervention: Zygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy.

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

Outcomes:

Outcome name How to be measured Primary

Secondary • Soft tissue

  • Bone gain • Measuring soft tissue thickness
  • Measuring soft tissue recession.
  • Measuring bone width from postoperative cone beam CT.

Time: the patient will be asked to make postoperative CT after 6 months of the surgery.

Study Design: A prospective Randomized clinical trial (two arms).

Research question:

Does the use of a xenogenic malleable bone shell in zygomatic implant rehabilitation improve bone gain, soft tissue contour and stability, thereby enhancing peri-implant tissue integrity and optimizing functional and aesthetic outcomes?"

Being tested
Group A, Group B
Keywords
Zygomatic implants, Grafting, Tunnel and channel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group AProcedure or surgery

    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 BProcedure or surgery

    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

Study groups in NCT07394179
Study groupRoleWhat they receive
group AActive comparatorZygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy.
Receives: Procedure: Group A
group BPlacebo comparatorZygomatic implants placed in Channel shape osteotomy with only soft tissue augmentation by using buccal bad of fat.
Receives: Procedure: Group B

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months of healing

Secondary outcomes (1)
  1. Bone gain

    CBCT used to determine bone gain in group A

    Measured: 6 months of healing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394179
Sponsor's protocol ID
Grafting with zygoma implants
Status last verified
Feb 2026
First submitted
4 Dec 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Group A and Group B in people with Zygomatic Implants, run by Fayoum University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hiatham Ahmed El maergy, Doctor (+201272251119, ha3591@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-soft tissue thickness 2-Soft tissue recession (time frame: 6 months of healing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.

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