Atrophic Edentulous MaxillaNCT07574606
Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
A study testing Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad in people with Atrophic Edentulous Maxilla and Zygomatic Implants, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Background and Rationale The rehabilitation of the severely atrophied maxilla utilizing zygomatic implants is a highly predictable and effective treatment modality. However, managing the peri-implant soft tissue in these complex cases remains a significant clinical challenge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrophic Edentulous Maxilla, Zygomatic Implants, Dental Implant
- What is being tested?
- Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Nov 2025to Aug 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
- Patients ≥18 years with severely atrophic maxilla.
- Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
- Indicated for zygomatic implant-supported fixed prosthesis.
- Sufficient mouth opening for zygomatic implants placement.
- Patients willing to sign informed consent and attend follow-ups.
Who cannot join
- Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
- Heavy smokers
- Previous radiotherapy or bisphosphonate therapy.
- Active sinus or nasal infection.
- Severe parafunctional habits (e.g., bruxism).
- Pregnant or lactating women.
- Patients with psychiatric disorders affecting compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an contact
aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER contact
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt
Cairo, New Cairo, 11835
lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor, 00201099925769, laziz@fue.edu.eg
mohamed abdelhamid maarouf eid, bachelor
About this study
Background and Rationale The rehabilitation of the severely atrophied maxilla utilizing zygomatic implants is a highly predictable and effective treatment modality. However, managing the peri-implant soft tissue in these complex cases remains a significant clinical challenge. Because zygomatic implants frequently emerge through thin, non-keratinized, and mobile alveolar mucosa rather than thick, attached gingiva, the peri-implant environment is highly susceptible to complications. Inadequate soft tissue thickness can lead to mucosal recession, exposure of the implant collar, plaque accumulation, and ultimately peri-implantitis, which threatens the long-term success of the prosthesis.
To mitigate these risks and achieve an optimal permucosal seal, soft tissue augmentation is often required. Vascularized soft tissue grafts are preferred in these compromised anatomical sites due to their robust blood supply and enhanced healing capacity. The Buccal Fat Pad (BFP) flap is a well-documented and frequently utilized technique for this purpose; however, its volume can be unpredictable, and it may be unavailable due to prior surgeries or anatomical deficiencies. Therefore, evaluating robust alternatives, such as the Palatal Pedicle Flap (PPF)-which utilizes the thick, keratinized palatal mucosa-is critical for optimizing surgical outcomes.
Read more
Study Design and Methodology This study is structured as a prospective, randomized controlled clinical trial utilizing a split-mouth design. The split-mouth approach is strategically chosen to eliminate inter-subject biological and immunological variability, allowing each patient to effectively serve as their own control. Patients presenting with a severely resorbed maxilla requiring bilateral zygomatic implant placement will be enrolled.
Following successful implant placement, the right and left maxillary quadrants will be randomized. One side will be assigned to receive soft tissue augmentation using the standard Buccal Fat Pad (BFP) flap, while the contralateral side will be assigned to receive the Palatal Pedicle Flap (PPF).
Surgical Intervention Overview All surgical procedures will be performed under appropriate anesthesia following standard sterile protocols.
For the BFP side: The buccal fat pad will be accessed via a vestibular mucosal incision, carefully bluntly dissected, mobilized, and advanced over the zygomatic implant collar without tension.
For the PPF side: A palatal pedicle flap will be meticulously outlined, elevated with its vascular supply intact, rotated, and adapted around the contralateral implant collar.
Both flaps will be secured using appropriate resorbable sutures to ensure tension-free primary closure and optimal tissue adaptation around the implant abutment interface. Post-operative care will adhere to standard institutional guidelines, including the prescription of appropriate analgesics, antibiotics, and antimicrobial mouth rinses.
Clinical Significance By systematically comparing the healing trajectories, tissue stability, and functional outcomes of the BFP and PPF techniques over a 6-month period, this trial aims to provide definitive, evidence-based guidance for soft tissue management in zygomatic implantology. Furthermore, it seeks to validate the PPF as a reliable and predictable reconstructive alternative in clinical scenarios where the buccal fat pad is deemed insufficient or inaccessible.
- Conditions
- Atrophic Edentulous Maxilla, Zygomatic Implants, Dental Implant, Soft Tissue Augmentation at Dental Implants, Soft Tissue Coverage, Buccal Fat Pad
- Being tested
- Palatal pedicle over zygomatic implant, covering zygomatic implants using buccal fat pad
- Keywords
- atophic edentulous maxilla, zygomatic implants, dental implants, soft tissue augmentation at dental implant site, soft tissue coverage, buccal fat pad, palatal pedicle flap, zygomatic implant recession
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal pedicle over zygomatic implantProcedure or surgery
a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone. From the palatal side
covering zygomatic implants using buccal fat padProcedure or surgery
covering the exposed part of the zygomatic implant using buccal fat pad from the buccal side.
| Study group | Role | What they receive |
|---|---|---|
| Palatal pedicle flap coverage over zygomatic implant | Active comparator | a palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone. From the palatal side Receives: Procedure: Palatal pedicle over zygomatic implant |
| Buccal fat pad coverage over zygomatic implant from the buccal side | Active comparator | Buccal fat pad coverage over zygomatic implant from the buccal side Receives: Procedure: covering zygomatic implants using buccal fat pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue thickness over the implant collar measured using a periodontal probe at 3 points on the buccal, surface mesial and distal to the implant platform.
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 posted8 May 2026
- Study start3 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Edentulous MaxillaStudies of the same condition, open and under way.
- 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
- Model description
- 12 implants in total: 6 implants covered with Palatal Pedicle Flap (Group A) 6 implants covered with Buccal Fat Pad (Group B) Intervention: After placement of zygomatic implants, soft tissue around the implant collar will be covered using either: Palatal Pedicle Flap (PPF) Buccal Fat Pad (BFP)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Safwat Abdelhamed, Future University in Egypt
- Investigators
- ahmed abozekry, associate professor, Study director, oral and maxillofacial surgery at FUEomar magdy el awady, bachelor, Principal investigatorRamy Ragab El beialy, Professor, Study chair, Cairo university in egypt oral and maxillofacial department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574606
- Sponsor's protocol ID
- FUE.REC(87)/11-2025
- Status last verified
- May 2026
- First submitted
- 6 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Soft Tissue Thickness Over Zygomatic Implants in Atrophied Maxilla Covered With Buccal Fat Pad vs. Palatal Pedicle Flap
- ClinicalTrials.gov ID
- NCT07574606
- Acronym / sponsor ID
- FUE.REC(87)/11-2025
- Conditions
- Atrophic Edentulous Maxilla, Zygomatic Implants, Dental Implant, Soft Tissue Augmentation at Dental Implants, Soft Tissue Coverage, Buccal Fat Pad
- Keywords
- atophic edentulous maxilla, zygomatic implants, dental implants, soft tissue augmentation at dental implant site, soft tissue coverage, buccal fat pad, palatal pedicle flap, zygomatic implant recession
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 May 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.
Background and Rationale The rehabilitation of the severely atrophied maxilla utilizing zygomatic implants is a highly predictable and effective treatment modality. However, managing the peri-implant soft tissue in these complex cases remains a significant clinical challenge. Because zygomatic implants frequently emerge through thin, non-keratinized, and mobile alveolar mucosa rather than thick, attached gingiva, the peri-implant environment is highly susceptible to complications. Inadequate soft tissue thickness can lead to mucosal recession, exposure of the implant collar, plaque accumulation, and ultimately peri-implantitis, which threatens the long-term success of the prosthesis.
To mitigate these risks and achieve an optimal permucosal seal, soft tissue augmentation is often required. Vascularized soft tissue grafts are preferred in these compromised anatomical sites due to their robust blood supply and enhanced healing capacity. The Buccal Fat Pad (BFP) flap is a well-documented and frequently utilized technique for this purpose; however, its volume can be unpredictable, and it may be unavailable due to prior surgeries or anatomical deficiencies. Therefore, evaluating robust alternatives, such as the Palatal Pedicle Flap (PPF)-which utilizes the thick, keratinized palatal mucosa-is critical for optimizing surgical outcomes.
Study Design and Methodology This study is structured as a prospective, randomized controlled clinical trial utilizing a split-mouth design. The split-mouth approach is strategically chosen to eliminate inter-subject biological and immunological variability, allowing each patient to effectively serve as their own control. Patients presenting with a severely resorbed maxilla requiring bilateral zygomatic implant placement will be enrolled.
Following successful implant placement, the right and left maxillary quadrants will be randomized. One side will be assigned to receive soft tissue augmentation using the standard Buccal Fat Pad (BFP) flap, while the contralateral side will be assigned to receive the Palatal Pedicle Flap (PPF).
Surgical Intervention Overview All surgical procedures will be performed under appropriate anesthesia following standard sterile protocols.
For the BFP side: The buccal fat pad will be accessed via a vestibular mucosal incision, carefully bluntly dissected, mobilized, and advanced over the zygomatic implant collar without tension.
For the PPF side: A palatal pedicle flap will be meticulously outlined, elevated with its vascular supply intact, rotated, and adapted around the contralateral implant collar.
Both flaps will be secured using appropriate resorbable sutures to ensure tension-free primary closure and optimal tissue adaptation around the implant abutment interface. Post-operative care will adhere to standard institutional guidelines, including the prescription of appropriate analgesics, antibiotics, and antimicrobial mouth rinses.
Clinical Significance By systematically comparing the healing trajectories, tissue stability, and functional outcomes of the BFP and PPF techniques over a 6-month period, this trial aims to provide definitive, evidence-based guidance for soft tissue management in zygomatic implantology. Furthermore, it seeks to validate the PPF as a reliable and predictable reconstructive alternative in clinical scenarios where the buccal fat pad is deemed insufficient or inaccessible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 12 implants in total: 6 implants covered with Palatal Pedicle Flap (Group A) 6 implants covered with Buccal Fat Pad (Group B) Intervention: After placement of zygomatic implants, soft tissue around the implant collar will be covered using either: Palatal Pedicle Flap (PPF) Buccal Fat Pad (BFP)
| Arm | Type | Receives |
|---|---|---|
| Palatal pedicle flap coverage over zygomatic implant | Active comparator | Procedure: Palatal pedicle over zygomatic implanta palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone. From the palatal side |
| Buccal fat pad coverage over zygomatic implant from the buccal side | Active comparator | Procedure: covering zygomatic implants using buccal fat padBuccal fat pad coverage over zygomatic implant from the buccal side |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥18 years with severely atrophic maxilla.
- Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
- Indicated for zygomatic implant-supported fixed prosthesis.
- Sufficient mouth opening for zygomatic implants placement.
- Patients willing to sign informed consent and attend follow-ups.
Key exclusion criteria (7 listed)
- Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
- Heavy smokers
- Previous radiotherapy or bisphosphonate therapy.
- Active sinus or nasal infection.
- Severe parafunctional habits (e.g., bruxism).
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 |
|---|---|---|
| Palatal pedicle over zygomatic implanta palatal pedicle is scored from the palatal mucosa with the greater palatine artery and is rotated to cover the zygomatic implant at the area of the zygomatic implant collar/zaga critical zone. From the palatal side | Procedure or surgery | Palatal pedicle flap coverage over zygomatic implant |
| covering zygomatic implants using buccal fat padcovering the exposed part of the zygomatic implant using buccal fat pad from the buccal side. | Procedure or surgery | Buccal fat pad coverage over zygomatic implant from the buccal side |
Primary outcome
Soft tissue thickness over the implant collar measured using a periodontal probe at 3 points on the buccal, surface mesial and distal to the implant platform.
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 20 May 2026.
- Individual participant dataSharing planned: Yes
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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.
waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an contact
aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER contact
ahmed abozekry, associate professor study director
oral and maxillofacial surgery at FUE
omar magdy el awady, bachelor principal investigator
Ramy Ragab El beialy, Professor study chair
Cairo university in egypt oral and maxillofacial department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatal pedicle over zygomatic implant and covering zygomatic implants using buccal fat pad in people with Atrophic Edentulous Maxilla and Zygomatic Implants, run by Future University in Egypt 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 7 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 20 May 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. 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 waleed fathy associate professor of oral and maxillofacial surgery at FUE, associate professor of oral an (+20 10 06614712 ext. 002, waleed.fathy@fue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue thickness over the implant collar measured using a periodontal probe at 3 points on the buccal, surface mesial and distal to the implant platform. (time frame: 6 months). 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 20 May 2026.