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

NCT07562334 | Recruiting

• 1 other identifier: 29425
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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?

Conditions

Soft Tissue Augmentation at Dental Implants

Keywords

evaluation of soft tissue thickness around zygomatic implants

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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.

Study Arms (2)

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

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

Biological: Coverage with PRF for Zygomatic implant placed

Interventions

Coverage with PRF for Zygomatic implant placed BIOLOGICAL

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

Coverage with PRF for Zygomatic implant placed; Coverage with buccal fat pad for Zygomatic implant placed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university, Faculty of dentistry

Cairo, Cairo Governorate, 11562, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 37330966 BACKGROUND

• Lima 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.

  PMID: 33340395 BACKGROUND

Related Links

• Use of Platelet-Rich Fibrin Membranes With Single Implant Placement for Peri-Implant Mucosal Thickness Augmentation: A Case Series Study
• Effect of the buccal fat pad in the prevention of zygomatic implant surgery postoperative complications: A pilot study

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Central Study Contacts

Caroline John Caroline John George, masters

CONTACT

+201282101184; caroline.john@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-12

Locations

EG (1)