Transforming Channel Shape Osteotomy Into Tunnel Shape Osteotomy for Zygomatic Implant. A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fayoum University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 1-soft tissue thickness 2-Soft tissue recession
Study Overview
Brief Summary
The evolution of zygomatic implant techniques, from the original procedures to the Zygomatic Anatomy-Guided Approach (ZAGA), has significantly improved outcomes for patients with severe maxillary atrophy. Despite these advancements, challenges such as peri-implant tissue recession, sinus complications, and aesthetic concerns persist. Bone augmentation and soft tissue enhancement techniques, including sinus lifts, connective tissue grafts, and buccal fat pad utilization, have been employed to address these issues with varying degrees of success. However, the need for predictable and stable bone regeneration and soft tissue contouring remains critical for long-term implant success.
The following study aims to assess bone gain, soft tissue contour, and stability after using bone lamina shell, providing a potential solution to enhance peri-implant tissue integrity and optimize functional and aesthetic outcomes in zygomatic implant rehabilitation
Detailed Description
The term "tunnel osteotomy" is used because the alveolar osseous entry point has a floor, lateral walls, and a more or less complete roof. When a tunnel osteotomy was chosen, the sinus membrane was perforated at the time of completion of the antrostomy. The objective was to achieve osseointegration at the neck level also to seal the sinus entrance in the long-term using: (1) a stable zygomatic implant with (2) a suitable threaded neck section (3) bordered by enough bone at the coronal entry, (4) stabilized by adequate apical zygomatic anchorage; and (5) connected to a rigid prosthesis that provides adequate masticatory load distribution. The "tunnel osteotomy" was also employed in ZAGA Type 3 cases when the alveolar bone adopts a triangular, buccally inclined, profile and the maxillary anterior wall was concave(23).
When inadequate residual bone architecture at the crestal level (less than 4 mm of thickness) was measured, the coronal osteotomy was buccally shifted to prevent future sinus or nasal-oral communication/fistula. Implant beds were designed to be carved as much as possible into both the buccal alveolar and maxillary wall bone with the limits of sinus lining integrity. This osteotomy type is known as a "channel osteotomy" and is noted when lateral walls and floor are present but with no roof(23).
On analyzing the evolution of the abovementioned technique (ZAGA), it is seen that the position of the neck of the zygomatic implants has been mobilized laterally from an intrasinus position to an extrasinus position. Different anterior techniques have thus sought to avoid maxillary sinus complications(19,24,25). However, hard and soft tissue infective and aesthetic complications (exposure of the implant threads) were detected(26-28).
Peri-implant hard and soft tissues are crucial for avoiding complications around conventional implants. Two aspects have been studied in this regard: buccal cortical bone and the thickness and width of the peri-implant keratinized mucosa. On the one hand, a recent systematic review has reported that a buccal cortical thickness of close to 2 mm was associated with less vertical bone resorption and less mucosal recession(29).
On the other hand, the presence of sufficient keratinized mucosa thickness exerts a protective effect against marginal bone loss(30,31). These abovementioned concepts to minimum necessary peri-implant tissues could be extrapolated to zygomatic implants. A number of techniques for bone and soft tissue enhancement around zygomatic implants have been described, with high success rates.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1 -Patients older than 21 years.
- •Patients with severe alveolar bone atrophy in posterior maxilla (residual alveolar crest less than 5mm in height, in the area immediately distal to the canine pillar)
- •Patients with at least more than half of the zygomatic implant platform diameter inside the alveolar bone crest.
Exclusion Criteria
- •1 - Patients with systemic conditions contra-indicating general anesthesia.
- •Patients with conditions contraindicating implant placement (e.g.: radiation to the head and neck, intra-venous bisphosphonates, uncontrolled Diabetes mellitus).
- •3. Patients with acute maxillary sinus infection or maxillary sinus cyst.
- •Restricted mouth opening (less than 3cm inter-arch distance anteriorly).
Arms & Interventions
group A
Zygomatic implants placed in Channel shape osteotomy with using xenogenic malleable bone shell to convert osteotomy type to tunnel osteotomy.
Intervention: Group A (Procedure)
group B
Zygomatic implants placed in Channel shape osteotomy with only soft tissue augmentation by using buccal bad of fat.
Intervention: Group B (Procedure)
Outcomes
Primary Outcomes
1-soft tissue thickness 2-Soft tissue recession
Time Frame: 6 months of healing
For soft tissue recession, a clinical visual exploration was performed, and defects were measured through a periodontal probe from fixed reference point (buccal surface of implant platform). For soft tissue thickness, a clinical method by using the average of three measurement points on the buccal side of the implant platform registered with a periodontal probe
Secondary Outcomes
- Bone gain(6 months of healing)
Investigators
haitham ahmed mohammed elmaergy
doctor
Fayoum University
