Treatment of Complex Ridge Defects With Custom Meshes

NCT07268456 | Completed

• 1 other identifier: EU2025/64
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Defects

Keywords

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

Outcome Measures

Primary Outcomes (6)

• planned bone volume

  planned bone volume when mesh was designed

  beginning to 4-6 months

• planned horizontal width

  planned horizontal width when mesh was designed

  beginning to 4-6 months

• planned vertical height

  planned vertical height when mesh was designed

  beginning to 4-6 months

• regenerated bone volume

  regenerated bone volume when mesh was applied to the patient

  beginning to 4-6 months

• regenerated horizontal width

  regenerated horizontal width when mesh was applied to the patient

  beginning to 4-6 months

• regenerated vertical height

  regenerated vertical height when mesh was applied to the patient

  beginning to 4-6 months

Secondary Outcomes (1)

• mesh exposure rate

  begining to 4-6 months

Study Arms (1)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Melikgazi, 38000, Turkey (Türkiye)

Location

Study Officials

• Duygu Kilic, Asst. prof.

  Erciyes Uni

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: February 6, 2025
• Primary Completion: March 10, 2025
• Study Completion: August 10, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)