- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268456
Treatment of Complex Ridge Defects With Custom Meshes
Volumetric Bone Reconstruction of Complex Alveolar Ridge Defects Using CAD/CAM-Customized Titanium Meshes: A Retrospective Study
Brief introduction: After tooth extraction, alveolar defects may hinder implant placement. Digital imaging and CAD/CAM advances allow creation of patient-specific titanium meshes for effective bone augmentation.
Objective: This study aimed to evaluate the clinical effectiveness of customized titanium meshes produced using computer-aided design and manufacturing (CAD/CAM) technologies in the horizontal and vertical augmentation of complex alveolar ridge defects prior to implant placement.
Study Overview
Status
Conditions
Detailed Description
Implant dentistry is a recognized and dependable method for restoring functionality and aesthetics in individuals with partial or total tooth loss. Following tooth loss or extraction, the alveolar bone undergoes gradual resorption and atrophy. This process generally commences with a notable horizontal decrease in ridge width over the initial six months, succeeded by vertical bone loss over time. Consequently, patients often have horizontal, vertical, or mixed alveolar defects that hinder later implant implantation.
Attaining sufficient bone volume before implant surgery is essential for enduring functional and aesthetic results. Horizontal and vertical bone augmentation procedures have demonstrated efficacy in enhancing alveolar ridge dimensions and facilitating the outcome of implant therapy. Among them, guided bone regeneration (GBR) is one of the most extensively utilized and evidence-based techniques, due to its reliability and capacity to facilitate new bone creation. Guided Bone Regeneration (GBR) employs resorbable or non-resorbable membranes alongside bone graft materials to safeguard the clot, prevent soft tissue encroachment, and promote osteogenesis within the defect.
Notwithstanding its prevalent application, the choice of membrane type continues to be a subject of contention. Resorbable membranes are manageable; nonetheless, they may exhibit inadequate mechanical stability, which could jeopardize the volume of regenerated bone. Conversely, non-resorbable membranes, especially titanium-reinforced polytetrafluoroethylene (PTFE) membranes, demonstrate enhanced space maintenance and they are considered more reliable for addressing extensive flaws.
In the late 1960s, titanium meshes were offered as a substitute for conventional membranes. These meshes provide improved stiffness and biocompatibility, rendering them appropriate for intricate ridge augmentation scenarios. Nevertheless, conventional titanium meshes require manual adjustment during surgery, potentially prolonging operative time and resulting in problems such as soft tissue dehiscence, mesh exposure, and postoperative infection due to inadequate fit.
Recent advancements in digital imaging and CAD/CAM technology have facilitated the creation of patient-specific titanium meshes, tailored according to preoperative cone beam computed tomography (CBCT) data. These bespoke meshes provide enhanced anatomical conformity, decrease intraoperative handling, reduce surgery duration, and mitigate problems linked to conventional meshes. Their smooth surface and exact fit to the bone defects correlate with reduced exposure rates and improved surgical results. However, limited studies have quantitatively assessed the volumetric outcomes of CAD/CAM-fabricated meshes using standardized CBCT-based protocols.
This study aims to assess the clinical and radiological effects of employing customized titanium meshes for alveolar ridge augmentation in individuals with horizontal and/or vertical bone defects. Key outcomes encompass bone volume increase, exposure rates, and the overall viability of the surgical treatment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Melikgazi
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Kayseri, Melikgazi, Turkey (Türkiye), 38000
- Erciyes University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Comprised the presence of alveolar bone defects involving both vertical and horizontal components in edentulous regions of the maxilla.
- Comprised the presence of alveolar bone defects involving both vertical and horizontal components in edentulous regions of the mandible.
Exclusion Criteria:
- uncontrolled systemic disease,
- poor oral hygiene,
- active oral infections,
- autoimmune or inflammatory oral diseases,
- pregnancy,
- histories of head and neck radiotherapy, chemotherapy in the past six months,
- corticosteroid use,
- or smoking more than 10 cigarettes per day.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
custom mesh group
All operations were performed under local anesthesia (4% articaine with 1:100,000 epinephrine). A mid-crestal incision with vertical releasing incisions was made, and full-thickness buccal and lingual/palatal flaps were elevated. Decortication was applied to enhance vascularization. Bone harvesting was performed from the mandibular ramus using bone scrapers. Autogenous bone was mixed 1:1 with deproteinized bovine bone (Tutobone, Tutogen Medical GmbH). The graft was inserted into the custom mesh, which was then secured over the defect using titanium screws. Grafting was completed through mesh openings until full volume was achieved. The mesh was covered with a resorbable collagen membrane, and primary closure was obtained with tension-free sutures |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
planned bone volume
Time Frame: beginning to 4-6 months
|
planned bone volume when mesh was designed
|
beginning to 4-6 months
|
|
planned horizontal width
Time Frame: beginning to 4-6 months
|
planned horizontal width when mesh was designed
|
beginning to 4-6 months
|
|
planned vertical height
Time Frame: beginning to 4-6 months
|
planned vertical height when mesh was designed
|
beginning to 4-6 months
|
|
regenerated bone volume
Time Frame: beginning to 4-6 months
|
regenerated bone volume when mesh was applied to the patient
|
beginning to 4-6 months
|
|
regenerated horizontal width
Time Frame: beginning to 4-6 months
|
regenerated horizontal width when mesh was applied to the patient
|
beginning to 4-6 months
|
|
regenerated vertical height
Time Frame: beginning to 4-6 months
|
regenerated vertical height when mesh was applied to the patient
|
beginning to 4-6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mesh exposure rate
Time Frame: begining to 4-6 months
|
the number of exposed titanum mesh
|
begining to 4-6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Duygu Kilic, Asst. prof., Erciyes Uni
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EU2025/64
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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