Zygomatic ImplantsRCT BFP ZAGANCT06968780
Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants
A study testing Buccal Fat Pad and Palatal Rotation Scarf Graft in people with Zygomatic Implants and Atrophic Maxilla, run by Cairo University at 1 site in Egypt.
Trial summary
Over the past 20 years, the demand for oral rehabilitation among edentulous patients has steadily increased. Traditionally, individuals with edentulous maxillae were treated using removable complete dentures. However, these often result in poor patient satisfaction due to instability and functional limitations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zygomatic Implants, Atrophic Maxilla, Soft Tissue Defect
- What is being tested?
- Buccal Fat Pad and Palatal Rotation Scarf Graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of age 18 years or more, who can understand and sign an informed consent.
- Patients with severely atrophic edentulous upper arch (Cawood \& Howell class IV, V, VI) that could not be restored by standard axial implants without augmentation.
- Patients with severely atrophic edentulous upper arch (Bedrossian classification inadequate bone in zones II or III or all three zones) that could not be restored by standard axial implants without augmentation.
- Good systemic health (ASA score I-II)
- Highly motivated patients with good compliance to oral hygiene habits.
Who cannot join
- Patients with cardiovascular disease or pulmonary disease or medical systemic condition that does not permit the surgical procedure under general anesthesia (ASA III, IV, V and VI).
- Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- Heavy smokers. (> 20 cigarettes daily)
- Patient with psychiatric problems, severe bruxism, or other parafunctional habits.
- Acute maxillary sinus infection or untreated maxillary sinus cyst.
- Malignancy or pathology in Maxilla or Zygoma.
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, 1 recruiting
- Recruiting
Cairo University
Cairo, Giza Governorate, 12613
Ramy R El-Bialy, PhD, Assoc. Prof, +201006608988, ramy.elbeialy@dentistry.cu.edu.eg
About this study
Official title: Buccal Pad of Fat Graft vs. Palatal Rotation Scarf Graft for Soft Tissue Enhancement and Prevention of Dehiscence Around Zygomatic Implants Placed in Patients With Severely Atrophic Maxilla: A Randomized Clinical Trial
Over the past 20 years, the demand for oral rehabilitation among edentulous patients has steadily increased. Traditionally, individuals with edentulous maxillae were treated using removable complete dentures. However, these often result in poor patient satisfaction due to instability and functional limitations. Dental rehabilitation with implants in the maxillary arch presents unique challenges, primarily due to the anatomical complexity of the maxilla and the need for adequate residual ridge dimensions for successful implant placement.
Following the extraction of maxillary teeth, patients experience rapid and progressive alveolar bone loss in both vertical and horizontal dimensions. This resorption is largely attributed to the absence of teeth and periodontal ligament fibers support, which are essential for transmitting mechanical forces that maintain bone homeostasis. In addition, the loss of maxillary molars accelerates pneumatization/expansion of the maxillary sinus, further reducing available bone volume. Contributing factors such as ill-fitting dentures and systemic health conditions can exacerbate this process, complicating implant placement even further.
To overcome these limitations, oral and maxillofacial surgeons have developed a range of advanced techniques, including tilted implants, sinus floor elevation, short implants, pterygoid implants, and most notably, zygomatic implants. Zygomatic implants bypass the atrophic alveolar ridge entirely by anchoring into the dense zygomatic bone, offering a reliable solution for patients with severely resorbed maxillae who are not candidates for conventional implant therapy.
Read the detailed description
The study aims to compare two different soft tissue augmentation techniques-buccal fat pad graft and palatal rotation scarf graft-to determine which method is more effective in enhancing soft tissue volume, improving tissue stability, and preventing dehiscence around zygomatic implants. Both grafts have shown promise in separate clinical applications, but this head-to-head comparison it will help in identifying the more optimal and predictable graft technique, the research aims to improve clinical outcomes, reduce complications, and enhance the long-term success of zygomatic implants in challenging clinical scenarios.
- Being tested
- Buccal Fat Pad, Palatal Rotation Scarf Graft
- Keywords
- ZAGA, Zygomatic Implants, Buccal Fat Pad, BFP, Palatal Rotation Graft, PRG, Scarf Graft, Atrophic Maxilla, Soft tissue Recession, Dehiscence, RCT, Zygoma, Implant
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal Fat PadProcedure or surgery
Also called Buccal pad of fat, BFP
BFP has a long successful history in oral surgery for its use in closure of Oroantral communication and taking advantage of the fact that it contains progenitor stem cells showing similar phenotype with (ASC) adipose-derived stem cells characteristics, which can similarly differentiate into the chondrogenic, adipogenic, or osteogenic lineage. Making them an invaluable reservoir for tissue engineering.
Palatal Rotation Scarf GraftProcedure or surgery
Also called Scarf Graft, Palatal pedicled graft, Palatal graft flap
This technique uses tissue from the palatal area, which has a rich blood supply placed around the neck of the zygomatic implant aiming to protect the mucosal tissues buccal to the exteriorized implants from capillary compression and subsequent soft tissue recession. The palatal rotation scarf graft has been proven to provide a robust, resilient soft tissue flap with good potential for long-term stability and esthetic outcomes around implants.
| Study group | Role | What they receive |
|---|---|---|
| Zygomatic implants placed using ZAGA approach & Buccal Fat Pad | Experimental | All patients involved in this study will be divided into two groups, each group will receive Zygomatic implants (Exteriorized ZAGA approach) alone (dual bilateral, quad) or in combination with axial implants if bone permits(hybrid). The first group (Control Group) will be treated with the buccal pad of fat graft, while the other (Study Group) is going to be treated by the palatal scarf graft after implant placement.
BFP has a long successful history in oral surgery for its use in closure of Oroantral communication and taking advantage of the fact that it contains progenitor stem cells showing similar phenotype with (ASC) adipose-derived stem cells characteristics, which can similarly differentiate into the chondrogenic, adipogenic, or osteogenic lineage. Making them an invaluable reservoir for tissue engineering. Receives: Procedure: Buccal Fat Pad |
| Zygomatic implants placed using ZAGA approach & Palatal Rotation Scarf Graft | Experimental | All patients involved in this study will be divided into two groups, each group will receive Zygomatic implants (Exteriorized ZAGA approach) alone (dual bilateral, quad) or in combination with axial implants if bone permits(hybrid). The first group (Control Group) will be treated with the buccal pad of fat graft, while the other (Study Group) is going to be treated by the palatal scarf graft after implant placement.
This technique uses tissue from the palatal area, which has a rich blood supply placed around the neck of the zygomatic implant aiming to protect the mucosal tissues buccal to the exteriorized implants from capillary compression and subsequent soft tissue recession. The palatal rotation scarf graft has been proven to provide a robust, resilient soft tissue flap with good potential for long-term stability and esthetic outcomes around implants Receives: Procedure: Palatal Rotation Scarf Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant Soft-Tissue Recessions (PSTR), Condition & Quality
Incidence of dehiscence and peri-implantitis based on clinical examination, reference photographs obtained, signs of infection, keratinized soft tissue thickness using periodontal probe.
Measured: 6 months
Secondary outcomes (1)
Implant Survival Rate
ORIS Success Criteria of Zygomatic Implants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zygomatic ImplantsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Superiority test. 2. Randomized Controlled Clinical Trial. 3. Parallel group study. 4. Allocation Ratio 1:1.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Mohamed Allam, Cairo University
- Investigators
- Ramy R El-Beialy, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968780
- Sponsor's protocol ID
- ZYGO-RCT-BFPvsPRG-2025
- Acronym
- RCT BFP ZAGA
- Status last verified
- Dec 2025
- First submitted
- 5 May 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcomes results
Publications
Blanco-Ruiz S, Molinero-Mourelle P, Blanco-Ruiz M, Fernandez-Tresguerres FG, Blanco-Samper S, Lopez-Quiles J. Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot study. Med Oral Patol Oral Cir Bucal. 2023 Jul 1;28(4):e371-e377. doi: 10.4317/medoral.25792.
PubMed 37330966
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buccal Pad of Fat Graft vs. Palatal Rotation Scarf Graft for Soft Tissue Enhancement and Prevention of Dehiscence Around Zygomatic Implants Placed in Patients With Severely Atrophic Maxilla: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06968780
- Acronym / sponsor ID
- RCT BFP ZAGA / ZYGO-RCT-BFPvsPRG-2025
- Keywords
- ZAGA, Zygomatic Implants, Buccal Fat Pad, BFP, Palatal Rotation Graft, PRG, Scarf Graft, Atrophic Maxilla
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 May 2025 (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.
Over the past 20 years, the demand for oral rehabilitation among edentulous patients has steadily increased. Traditionally, individuals with edentulous maxillae were treated using removable complete dentures. However, these often result in poor patient satisfaction due to instability and functional limitations. Dental rehabilitation with implants in the maxillary arch presents unique challenges, primarily due to the anatomical complexity of the maxilla and the need for adequate residual ridge dimensions for successful implant placement.
Following the extraction of maxillary teeth, patients experience rapid and progressive alveolar bone loss in both vertical and horizontal dimensions. This resorption is largely attributed to the absence of teeth and periodontal ligament fibers support, which are essential for transmitting mechanical forces that maintain bone homeostasis. In addition, the loss of maxillary molars accelerates pneumatization/expansion of the maxillary sinus, further reducing available bone volume. Contributing factors such as ill-fitting dentures and systemic health conditions can exacerbate this process, complicating implant placement even further.
To overcome these limitations, oral and maxillofacial surgeons have developed a range of advanced techniques, including tilted implants, sinus floor elevation, short implants, pterygoid implants, and most notably, zygomatic implants. Zygomatic implants bypass the atrophic alveolar ridge entirely by anchoring into the dense zygomatic bone, offering a reliable solution for patients with severely resorbed maxillae who are not candidates for conventional implant therapy.
Detailed description
The study aims to compare two different soft tissue augmentation techniques-buccal fat pad graft and palatal rotation scarf graft-to determine which method is more effective in enhancing soft tissue volume, improving tissue stability, and preventing dehiscence around zygomatic implants. Both grafts have shown promise in separate clinical applications, but this head-to-head comparison it will help in identifying the more optimal and predictable graft technique, the research aims to improve clinical outcomes, reduce complications, and enhance the long-term success of zygomatic implants in challenging clinical scenarios.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. Superiority test. 2. Randomized Controlled Clinical Trial. 3. Parallel group study. 4. Allocation Ratio 1:1.
| Arm | Type | Receives |
|---|---|---|
| Zygomatic implants placed using ZAGA approach & Buccal Fat Pad | Experimental | Procedure: Buccal Fat PadAll patients involved in this study will be divided into two groups, each group will receive Zygomatic implants (Exteriorized ZAGA approach) alone (dual bilateral, quad) or in combination with axial implants if bone permits(hybrid). The first group (Control Group) will be treated with the buccal pad of fat graft, while the other (Study Group) is going to be treated by the palatal scarf graft after implant placement. BFP has a long successful history in oral surgery for its use in closure of Oroantral communication and taking advantage of the fact that it contains progenitor stem cells showing similar phenotype with (ASC) adipose-derived stem cells characteristics, which can similarly differentiate into the chondrogenic, adipogenic, or osteogenic lineage. Making them an invaluable reservoir for tissue engineering. |
| Zygomatic implants placed using ZAGA approach & Palatal Rotation Scarf Graft | Experimental | Procedure: Palatal Rotation Scarf GraftAll patients involved in this study will be divided into two groups, each group will receive Zygomatic implants (Exteriorized ZAGA approach) alone (dual bilateral, quad) or in combination with axial implants if bone permits(hybrid). The first group (Control Group) will be treated with the buccal pad of fat graft, while the other (Study Group) is going to be treated by the palatal scarf graft after implant placement. This technique uses tissue from the palatal area, which has a rich blood supply placed around the neck of the zygomatic implant aiming to protect the mucosal tissues buccal to the exteriorized implants from capillary compression and subsequent soft tissue recession. The palatal rotation scarf graft has been proven to provide a robust, resilient soft tissue flap with good potential for long-term stability and esthetic outcomes around implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient of age 18 years or more, who can understand and sign an informed consent.
- Patients with severely atrophic edentulous upper arch (Cawood \& Howell class IV, V, VI) that could not be restored by standard axial implants without augmentation.
- Patients with severely atrophic edentulous upper arch (Bedrossian classification inadequate bone in zones II or III or all three zones) that could not be restored by standard axial implants without augmentation.
- Good systemic health (ASA score I-II)
- Highly motivated patients with good compliance to oral hygiene habits.
Key exclusion criteria (6 listed)
- Patients with cardiovascular disease or pulmonary disease or medical systemic condition that does not permit the surgical procedure under general anesthesia (ASA III, IV, V and VI).
- Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- Heavy smokers. (> 20 cigarettes daily)
- Patient with psychiatric problems, severe bruxism, or other parafunctional habits.
- Acute maxillary sinus infection or untreated maxillary sinus cyst.
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 |
|---|---|---|
| Buccal Fat PadAlso: Buccal pad of fat, BFPBFP has a long successful history in oral surgery for its use in closure of Oroantral communication and taking advantage of the fact that it contains progenitor stem cells showing similar phenotype with (ASC) adipose-derived stem cells characteristics, which can similarly differentiate into the chondrogenic, adipogenic, or osteogenic lineage. Making them an invaluable reservoir for tissue engineering. | Procedure or surgery | Zygomatic implants placed using ZAGA approach & Buccal Fat Pad |
| Palatal Rotation Scarf GraftAlso: Scarf Graft, Palatal pedicled graft, Palatal graft flapThis technique uses tissue from the palatal area, which has a rich blood supply placed around the neck of the zygomatic implant aiming to protect the mucosal tissues buccal to the exteriorized implants from capillary compression and subsequent soft tissue recession. The palatal rotation scarf graft has been proven to provide a robust, resilient soft tissue flap with good potential for long-term stability and esthetic outcomes around implants. | Procedure or surgery | Zygomatic implants placed using ZAGA approach & Palatal Rotation Scarf Graft |
Primary outcome
Peri-implant Soft-Tissue Recessions (PSTR), Condition & Quality
Time frame: 6 months
Incidence of dehiscence and peri-implantitis based on clinical examination, reference photographs obtained, signs of infection, keratinized soft tissue thickness using periodontal probe.
1 secondary outcome
Implant Survival Rate
Time frame: 6 months
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 12 Dec 2025.
- Background: PubMed 37330966Blanco-Ruiz S, Molinero-Mourelle P, Blanco-Ruiz M, Fernandez-Tresguerres FG, Blanco-Samper S, Lopez-Quiles J. Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot study. Med Oral Patol Oral Cir Bucal. 2023 Jul 1;28(4):e371-e377. doi: 10.4317/medoral.25792.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Outcomes results
Related trials for Zygomatic Implants
Active, not recruiting
Evaluation of Two Mini-implant Diameters in the Infra-zygomatic Crest Region.
Implant Stability
Not yet recruiting
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
Recruiting
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
Atrophic Edentulous Maxilla, Zygomatic Implants
Recruiting
Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla
Atrophic Edentulous Maxilla, Zygomatic Implants
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.
Ramy R El-Beialy, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buccal Fat Pad and Palatal Rotation Scarf Graft in people with Zygomatic Implants and Atrophic Maxilla, run by Cairo 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. 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. 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 Khaled M Allam, DDS (+201122189816, khaled-allam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant Soft-Tissue Recessions (PSTR), Condition & Quality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968780, which also lists 1 linked publication.
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 12 Dec 2025.