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Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial

Assessment of Soft Tissue Thickness Following Utilization of Buccal Pad of Fat Versus Platelet-rich Fibrin for Covering Zygomatic Implants: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07562334
Enrollment
24
Registered
2026-05-01
Start date
2025-12-01
Completion date
2027-05-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Augmentation at Dental Implants

Keywords

evaluation of soft tissue thickness around zygomatic implants

Brief 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?

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.

Interventions

BIOLOGICALCoverage with PRF for Zygomatic implant placed

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored by other type of treatment 2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of 2 conventional implants. 3. Lacking posterior maxillary bone support due to significant sinus pneumatization 4. Good systemic health (ASA score I-II) 5. Highly motivated patients

Exclusion criteria

1. Patient not willing to give his/her informed consent. 2. Patients with systemic disease that did not permit the surgical procedure (including general anesthesia). 3. Patients with uncontrolled diabetes or under bisphosphonate therapy. 4. Heavy smoker. (\> 20 cigarettes daily) 5. Patient with psychiatric problems, severe bruxism or other parafunctional habits. 6. Acute sinusitis. 7. Malignancy or pathology in Maxilla or Zygoma.

Design outcomes

Primary

MeasureTime frameDescription
The peri-implant soft tissue thicknessClinical 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)

Secondary

MeasureTime frameDescription
Postoperative complicationsClinical 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.Recording of frequency and Incidence of Zygomatic fracture/oroantral communication/implant failure

Countries

Egypt

Contacts

CONTACTCaroline John Caroline John George, masters
caroline.john@dentistry.cu.edu.eg+201282101184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026