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

Cairo University24 enrolled

Overview

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?

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Soft Tissue Augmentation at Dental Implants

Interventions

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Cairo university, Faculty of dentistry

Cairo, Cairo Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Postoperative complications

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

Central Contacts

Caroline John Caroline John George, masters

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.