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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCairo University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coverage with PRF for Zygomatic implant placed

    Biological/Vaccine

    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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Coverage with PRF for Zygomatic implant placedExperimental treatment 1 intervention
Group B: Coverage with buccal fat pad for Zygomatic implant placedActive comparator 1 intervention

Trial outcomes

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)

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.

Secondary outcomes

1

Postoperative complications

Recording of frequency and Incidence of Zygomatic fracture/oroantral communication/implant failure

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.

Other outcomes

Sponsors and contacts

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