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.
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.
Egypt1 site
Fayoum University
Al Fayyum, 63514
Arfa Sabry Gomma, Professor, +20842114095, ash02@fayoum.edu.eg
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?"
- Conditions
- Zygomatic Implants
- 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 group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Zygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy. Receives: 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. Receives: Procedure: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygomatic ImplantsStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haitham ahmed mohammed elmaergy, Fayoum University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Channel Shape Osteotomy Into Tunnel Shape Osteotomy for Zygomatic Implant. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07394179
- Acronym / sponsor ID
- Grafting with zygoma implants
- Conditions
- Zygomatic Implants
- Keywords
- Zygomatic implants, Grafting, Tunnel and channel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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?"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Group AZygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy. |
| group B | Placebo comparator | Procedure: Group BZygomatic implants placed in Channel shape osteotomy with only soft tissue augmentation by using buccal bad of fat. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Aafter 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 | Procedure or surgery | group A |
| Group Bafter 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 | Procedure or surgery | group B |
Primary outcome
1-soft tissue thickness 2-Soft tissue recession
Time frame: 6 months of healing
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
1 secondary outcome
Bone gain
Time frame: 6 months of healing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant
Severe Maxillary Atrophy
Enrolling by invitation
Failure Rate of Infra-Zygomatic Orthodontic Mini-Screws
Orthodontic Anchorage Procedures
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Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.