Reinforced PTFE Meshes Versus Customized Titanium Meshes
1 other identifier
interventional
50
1 country
1
Brief Summary
The objective of this study is to compare two surgical techniques for the treatment of the maxillary and mandibular bone atrophies.. Therefore, the main purpose is to compare the (i) the percentage of post-operative complications (ii) the three-dimensional bone gain with customized titanium meshes (test group - the medical device is digitally designed and made with customized laser sintering modality, customized to the defect of each patient) and with titanium-reinforced PTFE mesh (control group - the medical device is cut, shaped, and manually modelled to the patient's defect by the operator himself.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedMarch 14, 2025
March 1, 2025
2.7 years
December 6, 2019
March 12, 2025
Conditions
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 between 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 the 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.
- +11 more secondary outcomes
Study Arms (2)
Group A - control group
ACTIVE COMPARATOR25 patients will undergo bone regeneration with a titanium reinforced PTFE Mesh (RPM - Osteogenics Lubbock Texas USA), manually shaped and modeled by the operator during surgery (traditional technique), covered with collagen membranes of medium-rapid resorption (Vitala - Osteogenics Lubbock Texas USA)
Group B - Test group
EXPERIMENTAL25 patients undergo bone regeneration with a custom-made titanium mesh (Yxoss CBR - Reoss Filderstadt Germany), digitally designed by an operator before the surgery (digital technique), covered by collagen membranes with medium-rapid resorption (Bio-Gide - Geistlich Baden Baden Germany)
Interventions
25 patients will undergo bone regeneration with a reinforced PTFE mesh, manually shaped and modelled by the operator during surgery (traditional technique), covered with collagen membranes of medium-rapid resorption
25 patients undergo bone regeneration with a custom-made titanium mesh, digitally designed by an operator before the surgery (digital technique), covered by collagen membranes with medium-rapid resorption
Eligibility Criteria
You may qualify if:
- Adult patients, over the age of 18, in good general health.
- Patients with partial edentulism of the maxilla or mandible, with a 2mm minimum to a 12mm maximum vertical bone defect, which requires a three-dimensional bone regeneration intervention in order to have a fixed implant supported rehabilitation.
- Obtaining informed consent for experimental treatment and processing the personal data.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GBR Academylead
Study Sites (1)
School of Dentistry - University of Bologna
Bologna, Italy, 40126, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giuseppe Corinaldesi, MD,DDS,MS
School of dentistry - University of Bologna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The surgeon is masked until the envelope is opened at the time of the surgery.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 6, 2019
First Posted
February 5, 2020
Study Start
March 1, 2020
Primary Completion
November 1, 2022
Study Completion
March 1, 2025
Last Updated
March 14, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- From January 2021
- Access Criteria
- Access credentials to journal resources
Original articles in international journals