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CompletedNCT07268456Updated Dec 19, 2025

Treatment of Complex Ridge Defects With Custom Meshes

An observational study in Bone Defects, sponsored by TC Erciyes University. Completed at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by TC Erciyes University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
15
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bone Defects

Keywords

  • Alveolar ridge augmentation
  • CAD/CAM
  • Customized titanium mesh
  • Guided bone regeneration
  • Mesh exposure
  • Volumetric analysis
03

In context

Lead sponsor

TC Erciyes University is the lead sponsor of 341 studies on the registry; 76 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This retrospective study included all patients who underwent bone augmentation using customized titanium meshes at the Department of Periodontology, Faculty of Dentistry, Erciyes University, between July 2022 and June 2024.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. planned bone volume

    planned bone volume when mesh was designed

    Time frame: beginning to 4-6 months

  2. planned horizontal width

    planned horizontal width when mesh was designed

    Time frame: beginning to 4-6 months

  3. planned vertical height

    planned vertical height when mesh was designed

    Time frame: beginning to 4-6 months

  4. regenerated bone volume

    regenerated bone volume when mesh was applied to the patient

    Time frame: beginning to 4-6 months

  5. regenerated horizontal width

    regenerated horizontal width when mesh was applied to the patient

    Time frame: beginning to 4-6 months

  6. regenerated vertical height

    regenerated vertical height when mesh was applied to the patient

    Time frame: beginning to 4-6 months

Secondary outcomes

  1. mesh exposure rate

    the number of exposed titanum mesh

    Time frame: begining to 4-6 months

07

Study locations

1 site
  • Erciyes University
    Kayseri, Melikgazi 38000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to privacy and ethical restrictions.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07268456
Lead sponsor
TC Erciyes University
Responsible party
Duygu Kilic (Principal Investigator, TC Erciyes University) — Principal investigator
First posted
Dec 5, 2025
Start date
Feb 6, 2025
Primary completion
Mar 10, 2025
Completion
Aug 10, 2025
Last update
Dec 19, 2025

Study contacts

Duygu Kilic, Asst. prof.
principal investigator · Erciyes Uni

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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