We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04286334
Recruitment Status : Completed
First Posted : February 27, 2020
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Alessandro Cucchi, GBR Academy

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.


Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Soft Tissue Infections Surgical Wound Dehiscence Bone Density Bone Loss in Jaw Device: Bone augmentation with cad-cam laser-sintered mesh Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Surgeon is masked until the envelope opening at the end of the surgery, just before surgery.
Primary Purpose: Treatment
Official Title: Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane: Randomized Clinical Trial
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Active Comparator: Group A - control Group
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
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.

Experimental: Group B - Test Group
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
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.




Primary Outcome Measures :
  1. The rate of healing complications after reconstructive surgery [ Time Frame: 6 months ]

    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


Secondary Outcome Measures :
  1. Level of anxiety of the patient measured with a Visual Analogue Scale (VAS) [ Time Frame: Immediately before/after surgery ]
    Level of anxiety measured with a Visual Analogue Scale (VAS), where 0 represents the absence of anxiety and 10 represents the maximum level of anxiety.

  2. Pain level of the patient measured on a Visual Analogue Scale (VAS) [ Time Frame: Post operative from immediately after surgery to the 14th day after the surgery ]
    Pain level measured on a Visual Analogue Scale (VAS), where 0 represents the absence of pain and 10 represents the maximum level of pain.

  3. Total Number of painkillers taken post-operative [ Time Frame: Post operative from immediately after surgery to the 14th day after the surgery ]
    Total amount of pain killers taken from post operative to the 14th day (a two week period) which will be recorded in the patient's diary.

  4. Dosage of painkillers [ Time Frame: Post operative from immediately after surgery to the 14th day after the surgery ]
    Dosage of painkillers measured as the number of painkillers per day, which will be reported in a diary by the patients.

  5. Limitation in daily functions measured on a Visual Analogue Scale (VAS) [ Time Frame: Post operative from immediately after surgery to the 14th day after the surgery ]
    Limitation in daily functions measured on a Visual Analogue Scale (VAS), where 0 represents the absence of limitations and 10 represents the total limitation.

  6. Number of patients' post-operative signs and symptoms [ Time Frame: From the 1st day to the 14th day after the surgery. ]
    Self-assessment of patient's post-operative signs and symptoms (absence or presence swelling, nausea, hematoma, bruising, bleeding), which will be reported in a diary by the patients.

  7. Discomfort level of the patient using a Post-operative Symptom Severity (PoSSe) [ Time Frame: Post operative, measured on 14th day after the surgery] ]

    Discomfort level measured using a Post-operative Symptom Severity (PoSSe) questionnaire.

    Questions are a forced choice, requiring the respondent to tick one box.

    The questions evaluate the discomfort level in different areas:

    • eating: ability to eat, ability to swallow, enjoyment of food, altered taste sensation;
    • speech: voice affected, inability to open mouth, speech affected
    • sensation: tingling of lips or tongue, numbness of lips or tongue
    • appearance: bruising of face and/or neck, swelling of face and/or neck, life affected by appearance
    • pain: days of pain, pain controlled by painkillers, life affected by pain
    • sickness: days of nausea and vomiting, number of attacks of nausea and vomiting on worst day
    • interference with daily activities: interference with work/housework/daily activities, interference with leisure activities

  8. Level of satisfaction of the patient using a Health-Related Quality of Life (HrQoL) [ Time Frame: 6 months and 12 months after the dental prosthesis dental prosthesis has been placed. ]

    Level of satisfaction measured using a Health-Related Quality of Life (HrQoL) questionnaire. Each of the questions are answered with the options of "I am quite satisfied, I'm satisfied, I have no idea, I am dissatisfied, and I am quite dissatisfied".

    The questions evaluate:

    • satisfaction with the overall treatment chewing ability
    • cleaning of the prothesis
    • esthetics of the prothesis
    • speaking ability

  9. Willingness of the patient to undergo the intervention recorded on a Visual Analogue Scale (VAS) [ Time Frame: Post operative measured on the 7th day and on the 14th day ]
    Willingness to undergo the intervention recorded on a Visual Analogue Scale (VAS) where 0 corresponds to "I will never undergo this type of surgery again" and 10 corresponds to "no problem repeating surgery if necessary".

  10. Time required for the CBCT analysis and design of the medical device [ Time Frame: Pre-operative, 2 weeks before the day of the surgery ]
    Time required for the CBCT analysis and design of the medical device measured in a total number of minutes.

  11. Total operative time required for the surgery, measured from immediately before to immediately after the surgery. [ Time Frame: During procedure ]
    Total operative time measured from the time of incision to the end of the suture.

  12. Total chair time measured from immediately before the surgery to immediately after the surgery. [ Time Frame: During procedure ]
    Total chair time measured from the time the patient enters the surgery to the time the patient leaves the room.

  13. Level of operator satisfaction Measured on a 5 point scale [ Time Frame: Immediately after the surgery ]
    Level of operator satisfaction rated on a 5-point scale, ranging from "absolutely not satisfied" to "absolutely satisfied".

  14. Level of operator confidence with the technique [ Time Frame: During procedure ]
    Confidence level with the technique used on a 5-point rating scale, ranging from "absolutely not confident" to " absolutely confident".

  15. Costs related to the technique [ Time Frame: Immediately after the surgery ]
    Costs related to the GBR technique measured as the total costs of the materials used: number of pins, number of screws, number of membranes, number of biomaterials, number of sutures.

  16. Operator anxiety level recorded on a Visual Analogue Scale (VAS) [ Time Frame: From 3 days before the surgery to immediately before the surgery, during the intervention and at the 14th day after the surgery. ]
    Operator anxiety level recorded on a Visual Analogue Scale (VAS), where 0 represents the absence of anxiety and 10 represents the maximum level of anxiety.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286334


Locations
Layout table for location information
Italy
School of Dentistry - University of Bologna
Bologna, Italy, 40126
Sponsors and Collaborators
GBR Academy
Investigators
Layout table for investigator information
Study Director: Giuseppe Corinaldesi, MD, DDS, MS school of dentistry - University of Bologna
Layout table for additonal information
Responsible Party: Alessandro Cucchi, Principal Investigator, GBR Academy
ClinicalTrials.gov Identifier: NCT04286334    
Other Study ID Numbers: CMF 01/2017
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Original articles in international journals
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: From May 2020
Access Criteria: Access credentials to journal resources

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Soft Tissue Infections
Surgical Wound Dehiscence
Surgical Wound
Wounds and Injuries
Infections
Postoperative Complications
Pathologic Processes