Treatment of Complex Ridge Defects With Custom Meshes

NCT ID: NCT07268456

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2025-08-10

Brief Summary

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.

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.

Conditions

Bone Defects

Keywords

Alveolar ridge augmentation; CAD/CAM; Customized titanium mesh; Guided bone regeneration; Mesh exposure; Volumetric analysis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Duygu Kilic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duygu Kilic, Asst. prof.

Role: PRINCIPAL_INVESTIGATOR

Erciyes Uni

Locations

Erciyes University

Kayseri, Melikgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EU2025/64

Identifier Type: -

Identifier Source: org_study_id