Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane

NCT04286334 | Completed DMC

• 1 other identifier: CMF 01/2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of alveolar ridge deficiencies is considered major limitation to achieve an implant-prosthetic restoration with high aesthetics and stability over time. Guided Bone Regeneration (GBR) can be considered an effective solution for bone augmentation. The most advanced technology of GBR is the customized titanium mesh, which is developed with a fully digital work flow system. The aim of this study is to evaluate complications and bone augmentation rates after GBR, based on customized meshes with or without collagen membranes. After ethical committee approval, 30 patients with horizontal and/or vertical bone defects were enrolled and treated according to the study protocol. During reconstructive surgery (T0), patients were randomly divided into two study groups: 15 patients were treated by means of a custom-made mesh without collagen membrane (Group A - Control Group), while 15 patients were treated by means of a custom-made titanium mesh with a collagen membrane (Group B - Test Group). All sites were grafted with a mixture 50:50 of autogenous bone and xenograft and primary closures of surgical sites were obtained to ensure a submerged healing of the meshes. After 6 months (T1), re-entry surgery was completed to remove the meshes, evaluate the augmented volume and to place implants in the augmented sites. After 3 months (T2), soft tissue management was accomplished with implant exposure and a connective tissue graft, before prosthetic restoration (T3). Data collection included surgical and healing complications, planned bone volume (PBV) and reconstructed bone volume (RBV), pseudo-periosteum type, bone density, implant success, and crestal bone loss. A statistical analysis of recorded data was performed to investigate any statistically significant differences between the study group and statistical significance was set at a=0.05.

Conditions

Surgical Procedure, Unspecified; Soft Tissue Infections; Surgical Wound Dehiscence; Bone Density; Bone Loss in Jaw

Outcome Measures

Primary Outcomes (1)

• The rate of healing complications after reconstructive surgery

  Healing complications are evaluated based on the chronological order in which they occur: * immediate exposure occurs within the 1st month * early exposure occurs between the 1st and the 3rd month * late exposure occurs after the 3rd month Evaluation of low-grade and high-grade infection of medical devices used for bone regeneration. The former complications are classified as: * Class A, including flap damage (soft tissue perforation or laceration) * Class B, including neurological damage (paresthesia or disesthesia) * Class C,including vascular damage (hemorrhage). The latter complications are divided into four classes, according to the presence and extent of exposure, as well as the presence of a purulent exudate: * Class I, membrane exposure \<3 mm, no purulent exudate * Class II membrane exposure \>=3mm, no purulent exudate * Class III: membrane exposure, with purulent exudate

  6 months

Secondary Outcomes (16)

• Level of anxiety of the patient measured with a Visual Analogue Scale (VAS)

  Immediately before/after surgery

• Pain level of the patient measured on a Visual Analogue Scale (VAS)

  Post operative from immediately after surgery to the 14th day after the surgery

• Total Number of painkillers taken post-operative

  Post operative from immediately after surgery to the 14th day after the surgery

• Dosage of painkillers

  Post operative from immediately after surgery to the 14th day after the surgery

• Limitation in daily functions measured on a Visual Analogue Scale (VAS)

  Post operative from immediately after surgery to the 14th day after the surgery

Study Arms (2)

Group A - control Group

ACTIVE COMPARATOR

Customized titanium mesh without collagen membrane 15 patients will undergo bone regeneration with custom-made mesh without a collagen membrane. (Meshes - 3D-mesh BTK, Biotec, Vicenza, Italy.) Digitally designed by an operator before the surgery (digital technique).

Device: Bone augmentation with cad-cam laser-sintered mesh

Group B - Test Group

EXPERIMENTAL

Customized titanium mesh with collagen membrane 15 patients will undergo bone regeneration with a custom-made titanium mesh (BTK, Biotec- Vicenza, Italy). Digitally designed by an operator before the surgery (digital technique), covered by collagen membrane (Cytoplast RTM, Osteogenics, deore materials, Verona, Italy).

Device: Bone augmentation with cad-cam laser-sintered mesh

Interventions

Bone augmentation with cad-cam laser-sintered mesh DEVICE

Titanium meshes cad cam laser-sintered were applied in sites with alveolar bone deficiency in order to regenerate the bone volume in need of implant-prosthetic restorations.

Group A - control Group; Group B - Test Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Poor oral hygiene,
• Untreated periodontal disease
• Smoking habit\> 10 cigarettes / day;
• Abuse of alcohol or drugs
• Pregnancy
• Patients with odontostomatological infections and / or systemic infections in progress;
• Patient with uncontrolled diabetes mellitus or other metabolic diseases;
• Patients with severe changes in liver and kidney function.
• Patients with confirmed uncontrolled autoimmune disorders.
• Patients subjected radiation therapy in the head or neck region in the last 5 years.
• Patients undergoing immunosuppressive and / or immunocompromised therapy

Sponsors & Collaborators

• GBR Academy: lead

Study Sites (1)

School of Dentistry - University of Bologna

Bologna, 40126, Italy

Location

MeSH Terms

Conditions

Soft Tissue Infections; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Corinaldesi, MD, DDS, MS

  school of dentistry - University of Bologna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeon is masked until the envelope opening at the end of the surgery, just before surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 27, 2020
• Study Start: December 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: August 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From May 2020
• Access Criteria: Access credentials to journal resources

Locations

IT (1)