Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes

NCT04332679 | Completed DMC

• 1 other identifier: CMF 01/2013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare two surgical techniques for the treatment of the mandibular bone atrophies: Dense PTFE titanium-reinforced membranes (Group A) versus Titanium mesh covered with cross-linked collagen membranes (Group B). Therefore, the main purposes are to compare test and control regarding (i) the percentage of post-operative complications (ii) the three-dimensional bone gain (iii) histological, histomorphometrical and microCT outcomes (iv) perImplant bone loss and soft tissue parameters.

Conditions

Surgical Procedure, Unspecified; Soft Tissue Infections; Bone Density; Bone Loss; Dental Implant

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 (10)

• Implants Insertion Torque

  during surgery

• Change in implant Stability

  during surgery/after 6 months

• Vertical bone gain

  at 6 months

• Bone tissue area (B.ar)

  at 6 months

• Bone volume (B.V)

  at 6 months

Study Arms (2)

Group A - control group

ACTIVE COMPARATOR

20 patients treated by means of a dense PTFE (d-PTFE) titanium-reinforced membrane (Cytoplast Ti-250XL; Osteogenics Biomedical) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).

Device: Group A - control group

Group B - Test group

EXPERIMENTAL

20 patients treated by means of Ti mesh (Trinon Titanium; Karlsruhe, Germany) and cross-linked collagen membrane (Osseoguard, Zimmer Biomet, Warsaw, IN, USA) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).

Device: Group B - Test group

Interventions

Group A - control group DEVICE

20 patients treated by means of a dense PTFE (d-PTFE) titanium-reinforced membrane (Cytoplast Ti-250XL; Osteogenics Biomedical) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).

Group A - control group

Group B - Test group DEVICE

20 patients treated by means of Ti mesh (Trinon Titanium; Karlsruhe, Germany) and cross-linked collagen membrane (Osseoguard, Zimmer Biomet, Warsaw, IN, USA) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).

Group B - Test group

Eligibility Criteria

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

You may qualify if:

• edentulism in posterior regions of the mandible with vertical and horizontal bone resorption of the alveolar ridge requiring three-dimensional bone regeneration and implant-supported rehabilitation
• a vertical peri-implant bone defect of ≥ 2 mm in the alveolar ridge that must be regenerated after placement of implants in a three-dimensional 'ideal' position;
• capacity to understand and accept the conditions of the study; and 4 continuing participation in the study for at least 1 year of follow up.

You may not qualify if:

• residual bone height \< 5 mm;
• insufficient oral hygiene;
• a smoking habit of \> 10 cigarettes/day;
• abuse of alcohol or drugs;
• pregnancy;
• acute local or systemic infection;
• uncontrolled diabetes or other metabolic disease;
• severe hepatic or renal dysfunction; HIV, HBV, or HCV;
• chemotherapy or radiotherapy within the last 5 years;
• immunosuppression therapy;
• autoimmune disorders;
• bisphosphonate therapy

Sponsors & Collaborators

• GBR Academy: lead

Study Sites (1)

School of Dentistry - University of Bologna

Bologna, 40126, Italy

Location

Related Publications (1)

• Cucchi A, Vignudelli E, Fiorino A, Pellegrino G, Corinaldesi G. Vertical ridge augmentation (VRA) with Ti-reinforced d-PTFE membranes or Ti meshes and collagen membranes: 1-year results of a randomized clinical trial. Clin Oral Implants Res. 2021 Jan;32(1):1-14. doi: 10.1111/clr.13673. Epub 2020 Oct 19.

  PMID: 33017060 DERIVED

MeSH Terms

Conditions

Soft Tissue Infections; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Infections; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Giuseppe Corinaldesi

  unibo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) 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: Doctor

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 3, 2020
• Study Start: September 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-03

Data Sharing

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

Locations

IT (1)