Dynamic Navigation for Zygomatic Implant Rehabilitation Using an Intraoral Reference System: Evaluation of a New Zygomatic Implant Design

University of Bologna22 enrolled

Overview

This clinical study aims to evaluate the effectiveness and safety of zygomatic implants placed using dynamic navigation technology. Specifically, it compares two types of zygomatic implants with different surface characteristics: one with a fully rough surface and another with a partially smooth (machined) surface near the gum line. The goal is to determine whether surface design affects surgical performance, healing, implant success, and patient outcomes. A total of 22 patients with severe upper jaw bone loss will receive both types of implants-one on each side of the upper jaw-in a randomized, split-mouth design. The study also evaluates pain, swelling, healing time, and patient quality of life over a 5-year follow-up period.

This prospective, randomized, split-mouth clinical study investigates the use of dynamic navigation for the placement of zygomatic implants in patients with severely atrophic maxillae. The primary aim is to compare two different surface configurations of zygomatic implants: a fully rough surface versus a partially machined (smooth) coronal surface. Each of the 22 enrolled patients will receive both implant types-one per side-allowing for direct intra-patient comparison. All surgeries are planned using three-dimensional imaging and performed with a dynamic navigation system (ImplaNav), calibrated for the longer drills required for zygomatic implant sites. The study evaluates surgical accuracy, implant stability, preparation time, postoperative pain and swelling, sinus membrane response, and long-term implant and prosthetic success. Patient quality of life is also monitored over a 5-year follow-up using standardized questionnaires and radiographic assessments. This study aims to provide evidence on whether implant surface design influences clinical performance and healing outcomes in zygomatic implant rehabilitation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Patients requiring partial or full rehabilitation of the atrophic maxilla Candidates for placement of at least one zygomatic implant per side (right and left), connected to at least one standard or zygomatic implant Severe maxillary atrophy confirmed by CT scan, with insufficient bone for conventional implants or only sufficient bone for 2 frontal implants (minimum diameter 3.5 mm, length 8 mm) Residual alveolar crest height ≤ 4 mm beneath the maxillary sinus Age ≥ 18 years Signed informed consent Exclusion Criteria: General contraindications to oral surgery History of radiation therapy to the head and neck exceeding 70 Gy Compromised or suppressed immune system Current or past use of intravenous bisphosphonates Uncontrolled diabetes mellitus Alcohol or drug dependency Psychiatric disorders Pregnancy or breastfeeding Participation in other clinical trials Inability to attend a 5-year follow-up Limited mouth opening (\< 3.5 cm interincisal distance) Absence of opposing dentition or lower prosthesis Acute or chronic infection in the intended implant site Untreated active periodontal disease Poor oral hygiene motivation Radiographic signs of sinus membrane inflammation or ostium obstruction

Outcomes

Primary Outcomes

Implant Success Rate of Zygomatic Fixtures

The success of each zygomatic implant will be assessed clinically by evaluating the absence of pain, absence of mobility or rotation under contra-torque testing, and the presence of healthy peri-implant tissues. Clinical evaluation will be supported by radiographic analysis to confirm peri-implant bone maintenance and the absence of pathological signs.

Time frame: 5 years after implant placement

Secondary Outcomes

Surgical Site Preparation Time

Time required to prepare each zygomatic implant site will be recorded, from the start of the first drill to the complete insertion of the implant. The comparison aims to detect differences between the rough and partially machined implant groups.

Time frame: Intraoperative (during implant placement)

Radiographic Evaluation of Peri-Implant Bone

Assessment of peri-implant bone levels will be performed through standardized radiographs (OPT and teleradiography) and analyzed using calibrated software. Bone changes will be compared between implant types.

Time frame: At prosthesis delivery, and at 1, 3, and 5 years post-loading

Peri-implant Probing Depth (PD)

Mean probing depth, in millimetres, measured circumferentially around each implant to assess peri-implant soft-tissue health. Results will be reported as mean ± SD per implant.

Time frame: 1, 3, and 5 years after functional loading

Number of Implants with Bleeding on Probing (BOP)

Count of dental implants that exhibit bleeding upon gentle circumferential probing (≤ 0.25 N). The result will be reported as the total number of affected implants and the corresponding percentage of all implants examined at each follow-up visit.

Time frame: 1, 3, and 5 years after functional loading

Number of Implants with Suppuration

Count of dental implants showing the presence of suppuration (pus discharge) upon gentle probing (≤ 0.25 N) during clinical examination. The result will be reported as the number and percentage of affected implants at each follow-up visit.

Time frame: 1, 3, and 5 years after functional loading

Dynamic Navigation for Zygomatic Implant Rehabilitation Using an Intraoral Reference System: Evaluation of a New Zygomatic Implant Design

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes