Soft Tissue Augmentation at Dental ImplantsNCT07562334
Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial
A study testing Coverage with PRF for Zygomatic implant placed in people with Soft Tissue Augmentation at Dental Implants, run by Cairo University at 1 site in Egypt.
Trial summary
Would buccal pad of fat be comparable to platelet rich fibrin for Zygomatic implant coverage as a step for reconstruction of atrophic posterior maxilla, in terms of peri-implant soft tissue thickness and avoiding complicated postoperative sequalae? Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Augmentation at Dental Implants
- What is being tested?
- Coverage with PRF for Zygomatic implant placed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
- Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
- Lacking posterior maxillary bone support due to significant sinus pneumatization
- Good systemic health (ASA score I-II)
- Highly motivated patients
Who cannot join
- Patient not willing to give his/her informed consent.
- Patients with systemic disease that did not permit the surgical procedure (including general anesthesia).
- Patients with uncontrolled diabetes or under bisphosphonate therapy.
- Heavy smoker. (> 20 cigarettes daily)
- Patient with psychiatric problems, severe bruxism or other parafunctional habits.
- Acute sinusitis.
- 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, Faculty of dentistry
Cairo, Cairo Governorate, 11562
01223617956
About this study
Would buccal pad of fat be comparable to platelet rich fibrin for Zygomatic implant coverage as a step for reconstruction of atrophic posterior maxilla, in terms of peri-implant soft tissue thickness and avoiding complicated postoperative sequalae?
Read the detailed description
This study aims to assess whether the buccal fat pad might prevent mucosal dehiscence and avoid potential postoperative complications when buccal fat pad is used to cover the body part of the zygomatic implants compared to the platelet rich fibrin during the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable coverage for Zygomatic implant placement with the least postoperative complications also providing an appropriate soft tissue profile during the immediate loading phase preparing it for the final restoration.
- Being tested
- Coverage with PRF for Zygomatic implant placed
- Keywords
- evaluation of soft tissue thickness around zygomatic implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coverage with PRF for Zygomatic implant placedBiological
PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared. Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation. The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm. The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Coverage with PRF for Zygomatic implant placed | Experimental | PRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared. Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation. The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm. The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation Receives: Biological: Coverage with PRF for Zygomatic implant placed |
| Coverage with buccal fat pad for Zygomatic implant placed | Active comparator | Broad muco-periosteal dissection of the anterior maxilla and its lateral sides can easily be used to make an incision of the periosteum in the area of the wisdom teeth during implant insertion. The buccal fat pad will be dissected into the oral cavity after being enlarged with scissors. The pad can be moved forward and lower to cover the implants by gently pulling it with an atraumatic clamp. Resorbable sutures are then used to secure it to the palatal mucosa, The flap will be repositioned over the BPF and sutured to the palatine mucosa. The posterior implant typically has the easiest time achieving implant coverage.
To prevent premature traction, the dissection must be done very carefully. The pad must be gradually released from its capsule in order to complete the task. It is not problematic if there are pieces of the fat pad along the crestal suture. After surgery, this will turn into the epidermis in a few days.
The buccal fat pad going to be repositioned over implant body Receives: Biological: Coverage with PRF for Zygomatic implant placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peri-implant soft tissue thickness
The peri-implant soft tissue thickness using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe (HH12 periodontal probe, Deppeler SA)
Measured: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.
Secondary outcomes (1)
Postoperative complications
Recording of frequency and Incidence of Zygomatic fracture/oroantral communication/implant failure
Measured: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness and postoperative complications then at 6 months and 12 months interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Dec 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Augmentation at Dental 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline John George, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562334
- Sponsor's protocol ID
- 29425
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 37330966Lima VCDS, Miguel MMV, Ferraz LFF, Filho ABM, Jardini MAN, Santamaria MP. Use of Platelet-Rich Fibrin Membranes With Single Implant Placement for Peri-Implant Mucosal Thickness Augmentation: A Case Series Study. Clin Adv Periodontics. 2022 Mar;12(1):17-20. doi: 10.1002/cap.10143. Epub 2021 Jan 12.
PubMed 33340395
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07562334
- Acronym / sponsor ID
- 29425
- Keywords
- evaluation of soft tissue thickness around zygomatic implants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 1 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.
Would buccal pad of fat be comparable to platelet rich fibrin for Zygomatic implant coverage as a step for reconstruction of atrophic posterior maxilla, in terms of peri-implant soft tissue thickness and avoiding complicated postoperative sequalae?
Detailed description
This study aims to assess whether the buccal fat pad might prevent mucosal dehiscence and avoid potential postoperative complications when buccal fat pad is used to cover the body part of the zygomatic implants compared to the platelet rich fibrin during the reconstruction of atrophic maxilla. The expected benefit from the current study is to select the most suitable coverage for Zygomatic implant placement with the least postoperative complications also providing an appropriate soft tissue profile during the immediate loading phase preparing it for the final restoration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coverage with PRF for Zygomatic implant placed | Experimental | Biological: Coverage with PRF for Zygomatic implant placedPRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared. Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation. The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm. The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation |
| Coverage with buccal fat pad for Zygomatic implant placed | Active comparator | Biological: Coverage with PRF for Zygomatic implant placedBroad muco-periosteal dissection of the anterior maxilla and its lateral sides can easily be used to make an incision of the periosteum in the area of the wisdom teeth during implant insertion. The buccal fat pad will be dissected into the oral cavity after being enlarged with scissors. The pad can be moved forward and lower to cover the implants by gently pulling it with an atraumatic clamp. Resorbable sutures are then used to secure it to the palatal mucosa, The flap will be repositioned over the BPF and sutured to the palatine mucosa. The posterior implant typically has the easiest time achieving implant coverage. To prevent premature traction, the dissection must be done very carefully. The pad must be gradually released from its capsule in order to complete the task. It is not problematic if there are pieces of the fat pad along the crestal suture. After surgery, this will turn into the epidermis in a few days. The buccal fat pad going to be repositioned over implant body |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment
- Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants.
- Lacking posterior maxillary bone support due to significant sinus pneumatization
- Good systemic health (ASA score I-II)
- Highly motivated patients
Key exclusion criteria (7 listed)
- Patient not willing to give his/her informed consent.
- Patients with systemic disease that did not permit the surgical procedure (including general anesthesia).
- Patients with uncontrolled diabetes or under bisphosphonate therapy.
- Heavy smoker. (> 20 cigarettes daily)
- Patient with psychiatric problems, severe bruxism or other parafunctional habits.
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 |
|---|---|---|
| Coverage with PRF for Zygomatic implant placedPRF preparation and placement: Shortly before being positioned at the surgical site, the PRF was freshly prepared. Ten milliliters of blood were extracted from the antecubital vein and put into a test tube devoid of anticoagulant for the PRF preparation. The blood sample was centrifuged right away for 10-12 minutes at 3000 rpm. The PRF membrane was obtained by squeezing the fibrin clot between pieces of gauze after centrifugation | Biological | Coverage with PRF for Zygomatic implant placed, Coverage with buccal fat pad for Zygomatic implant placed |
Primary outcome
The peri-implant soft tissue thickness
Time frame: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.
The peri-implant soft tissue thickness using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe (HH12 periodontal probe, Deppeler SA)
1 secondary outcome
Postoperative complications
Time frame: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness and postoperative complications then at 6 months and 12 months interval.
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 1 May 2026.
- 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.
- Background: PubMed 33340395Lima VCDS, Miguel MMV, Ferraz LFF, Filho ABM, Jardini MAN, Santamaria MP. Use of Platelet-Rich Fibrin Membranes With Single Implant Placement for Peri-Implant Mucosal Thickness Augmentation: A Case Series Study. Clin Adv Periodontics. 2022 Mar;12(1):17-20. doi: 10.1002/cap.10143. Epub 2021 Jan 12.
- Use of Platelet-Rich Fibrin Membranes With Single Implant Placement for Peri-Implant Mucosal Thickness Augmentation: A Case Series StudyLink provided by the sponsor.
- Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot studyLink provided by the sponsor.
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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 Coverage with PRF for Zygomatic implant placed in people with Soft Tissue Augmentation at Dental Implants, 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 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 1 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 Caroline John Caroline John George, masters (+201282101184, caroline.john@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peri-implant soft tissue thickness (time frame: Clinical evaluation will be performed at the operation day, 72 hours, 1st week, 15 days, 1month, 4-month intervals will be the first assessment for the soft tissue thickness then at 6 months and 12 months interval.). 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 NCT07562334, which also lists 2 linked publications.
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 1 May 2026.