Clinical trial NCT06968780: Buccal Fat Pad vs. Palatal Rotation Scarf Grafts for Soft Tissue Management Around Zygomatic Implants: A Randomized Clinical Trial
Official title: Buccal Pad of Fat Graft vs. Palatal Rotation Scarf Graft for Soft Tissue Enhancement and Prevention of Dehiscence Around Zygomatic Implants Placed in Patients With Severely Atrophic Maxilla: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Zygomatic Implants
Atrophic Maxilla
Soft Tissue Defect
Soft Tissue Healing
Keywords: ZAGA
Zygomatic Implants
Buccal Fat Pad
BFP
Palatal Rotation Graft
PRG
Scarf Graft
Atrophic Maxilla
Soft tissue Recession
Dehiscence
RCT
Zygoma
Implant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Superiority test.
2. Randomized Controlled Clinical Trial.
3. Parallel group study.
4. Allocation Ratio 1:1.
Primary purpose: PREVENTION

Brief summary: Over the past 20 years, the demand for oral rehabilitation among edentulous patients has steadily increased. Traditionally, individuals with edentulous maxillae were treated using removable complete dentures. However, these often result in poor patient satisfaction due to instability and functional limitations. Dental rehabilitation with implants in the maxillary arch presents unique challenges, primarily due to the anatomical complexity of the maxilla and the need for adequate residual ridge dimensions for successful implant placement.

Following the extraction of maxillary teeth, patients experience rapid and progressive alveolar bone loss in both vertical and horizontal dimensions. This resorption is largely attributed to the absence of teeth and periodontal ligament fibers support, which are essential for transmitting mechanical forces that maintain bone homeostasis. In addition, the loss of maxillary molars accelerates pneumatization/expansion of the maxillary sinus, further reducing available bone volume. Contributing factors such as ill-fitting dentures and systemic health conditions can exacerbate this process, complicating implant placement even further.

To overcome these limitations, oral and maxillofacial surgeons have developed a range of advanced techniques, including tilted implants, sinus floor elevation, short implants, pterygoid implants, and most notably, zygomatic implants. Zygomatic implants bypass the atrophic alveolar ridge entirely by anchoring into the dense zygomatic bone, offering a reliable solution for patients with severely resorbed maxillae who are not candidates for conventional implant therapy.

Detailed description: The study aims to compare two different soft tissue augmentation techniques-buccal fat pad graft and palatal rotation scarf graft-to determine which method is more effective in enhancing soft tissue volume, improving tissue stability, and preventing dehiscence around zygomatic implants. Both grafts have shown promise in separate clinical applications, but this head-to-head comparison it will help in identifying the more optimal and predictable graft technique, the research aims to improve clinical outcomes, reduce complications, and enhance the long-term success of zygomatic implants in challenging clinical scenarios.

Eligibility criteria: Inclusion Criteria:

1. Patient of age 18 years or more, who can understand and sign an informed consent.
2. Patients with severely atrophic edentulous upper arch (Cawood \& Howell class IV, V, VI) that could not be restored by standard axial implants without augmentation.
3. Patients with severely atrophic edentulous upper arch (Bedrossian classification inadequate bone in zones II or III or all three zones) that could not be restored by standard axial implants without augmentation.
4. Good systemic health (ASA score I-II)
5. Highly motivated patients with good compliance to oral hygiene habits.

Exclusion Criteria:

1. Patients with cardiovascular disease or pulmonary disease or medical systemic condition that does not permit the surgical procedure under general anesthesia (ASA III, IV, V and VI).
2. Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
3. Heavy smokers. (\> 20 cigarettes daily)
4. Patient with psychiatric problems, severe bruxism, or other parafunctional habits.
5. Acute maxillary sinus infection or untreated maxillary sinus cyst.
6. Malignancy or pathology in Maxilla or Zygoma.

Primary outcomes:
measure: Peri-implant Soft-Tissue Recessions (PSTR), Condition & Quality
timeFrame: 6 months
Secondary outcomes:
measure: Implant Survival Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Ramy R El-Beialy, PhD
role: STUDY_DIRECTOR
References:
citation: 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.