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Wedge Implant Narrow Crests: Multi-center Clinical Study

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ClinicalTrials.gov Identifier: NCT03290729
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy

Brief Summary:
This study was designed as a multicentric prospective clinical trial to assess the clinical, biological and patient's perceived success of new wedge-shaped dental implants inserted in narrow ridges.

Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Procedure: wedge shape implants insertion Not Applicable

Detailed Description:

Due to the loss of dental elements, the bone crest undergoes a significant remodeling. Bone resorption begins immediately after dental extraction with a 40-60% reduction in horizontal and vertical direction of the alveolar ridge during the first 2 years. The most significant bone loss after tooth extraction occurs within the first 3 months, although modeling and remodeling of the alveoli have a great variability of time: bone structure and organization may not be complete even 24 weeks after dental extraction.

It is now known that crestal remodeling is closely related to the disappearance of the bundle bone, which is more representative of the buccal appearance of the alveolus. Its disappearance, especially in thin periodontal biotopes, can lead to significant recessions of hard and soft tissues.

Moreover, with a variable percentage, in many patients, crestal resorption continues over time due to a combination of factors involved: anatomical, metabolic and mechanical. Among these, the use of removable total or partial dentures can play an important role in accelerating the resurfacing process.

With these premises, it is common to find patients with atrophic crests when processing plans that provide implant support prosthetic rehabilitation.

A crestal bone thickness of at least 6 mm in the buco-lingual sense is considered sufficient to safely place a plant with a diameter of 4 mm. But when the width is lower, a variety of procedures and techniques have been proposed in literature that allow recreate the volumes needed for implant placement.

Horizontal lifting techniques with bone blocks (autologous, alloplastic, xeno-graft), guided bone regeneration, crest expansion technique have demonstrated a good long-term predictability of the inserted devices. However, some negatives related to these techniques need to be considered, such as increased morbidity for the patient, demand for advanced surgical skills for the operator, increased treatment costs, and increased therapy times.

Because of these observations, a new implant design has been proposed for specific use in narrow ridges. Its wedge shape and press-fit insertion make it possible to position it with a minimally invasive preparation of the implant site, performed with ultrasound technique.

Therefore, the use of this implant could allow effective and minimally invasive treatment of narrow edentulous crests up to 4 mm, with significant benefits to the patient in terms of morbidity, treatment costs and time.

Twelve clinical centers will treat patients with insertion of wedge-shaped implants in thin crests with a specific surgical protocol and clinical outcomes will be collected and analyzed.

The chosen medical device will be the Rex Tissue Level implant System. For each implant inserted, the clinical parameters will be recorded up to 5 years after insertion.

In addition, intermediate evaluations will be carried out at 1 year and 3 years after installation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Intervention Model: Single Group Assignment
Intervention Model Description: multicenter single cohort prospective study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wedge Implant for Minimally Invasive Treatment of Narrow Crests: a Prospective Multi-center Clinical Study
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : November 15, 2018
Estimated Study Completion Date : May 15, 2023

Arm Intervention/treatment
Experimental: narrow ridge
edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion
Procedure: wedge shape implants insertion
Narrow dental implants inserted in narrow ridges




Primary Outcome Measures :
  1. implant survival rate [ Time Frame: 1 year after surgery ]
    health of the inserted implants


Secondary Outcome Measures :
  1. surgical procedure evaluation [ Time Frame: during surgery ]
    handling assessment of the implant system by the surgeons

  2. surgical procedure evaluation [ Time Frame: 1 hour after surgery ]
    assessment of the invasivity of the surgical procedure from the patient

  3. implant stability 14 [ Time Frame: 14 days after surgery ]
    resonance frequence analysis of the implant

  4. implant stability 1 month [ Time Frame: 1 month after surgery ]
    resonance frequence analysis of the implant

  5. implant stability 2 months [ Time Frame: 2 months after surgery ]
    resonance frequence analysis of the implant

  6. implant stability 3 months [ Time Frame: 3 months after surgery ]
    resonance frequence analysis of the implant

  7. implant stability 4 months [ Time Frame: 4 months after surgery ]
    resonance frequence analysis of the implant

  8. implant stability 5 months [ Time Frame: 5 months after surgery ]
    resonance frequence analysis of the implant

  9. implant stability 6 months [ Time Frame: 6 months after surgery ]
    resonance frequence analysis of the implant

  10. implant stability 1 year [ Time Frame: 1 year after surgery ]
    resonance frequence analysis of the implant

  11. implant stability 3 years [ Time Frame: 3 years after surgery ]
    resonance frequence analysis of the implant

  12. implant stability 5 years [ Time Frame: 5 years after surgery ]
    resonance frequence analysis of the implant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. indications for prosthetic rehabilitation supported by implants in the upper or lower arch, based on accurate diagnosis and treatment planning;
  2. the bone crest must be completely healed (at least six months after the tooth loss);
  3. residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction;
  4. presence of at least 10 mm bone height available for implant placement;
  5. age of the patient> 18 years;
  6. The patient must not carry any removable prosthesis on the treated area;
  7. the patient must be able to follow the protocol of study;
  8. informed written consent

Exclusion Criteria:

  1. acute myocardial infarction over the last 2 months;
  2. uncontrolled coagulation disorders;
  3. unmanaged diabetes (HBA1c> 7.5);
  4. radiotherapy to the head area in the last 24 months;
  5. immunocompromised, HIV positive or chemotherapy patients over the past 5 years;
  6. present or past treatment with intravenous bisphosphonates;
  7. psychological or psychiatric problems;
  8. abuse of alcohol or drugs;
  9. uncontrolled periodontal disease

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): NCT03290729


Contacts
Contact: claudio stacchi, Dr 0403992020 ext 0039 claudio@stacchi.it
Contact: teresa lombardi, Dr. 098171692 ext 0039 drteresalombardi@libero.it

Locations
Italy
Piezosurgery Academy Recruiting
Parma, PR, Italy, 43100
Contact: Claudio Stacchi, Dr.    0403992020 ext 0039    claudio@stacchi.it   
Contact: Teresa Lombardi, Dr.    098171692 ext 0039    drteresalombardi@libero.it   
Sub-Investigator: Andrea Alberghini Maltoni, Dr.         
Sub-Investigator: Gianluca Gregorig, Dr.         
Principal Investigator: Teresa Lombardi, Dr.         
Sub-Investigator: Carlo Marcato, Dr.         
Sub-Investigator: Fabio Marchi, Dr.         
Sub-Investigator: Emanuele Morella, Dr.         
Sub-Investigator: Francesco Oreglia, Dr.         
Sub-Investigator: Alberto Rebaudi, Dr.         
Sub-Investigator: Crescenzo Russo, Dr.         
Sub-Investigator: Giuseppe Sepe, Dr.         
Principal Investigator: Claudio Stacchi, Dr.         
Sub-Investigator: Tommaso Vercellotti, Dr.         
Sponsors and Collaborators
International Piezosurgery Academy
Investigators
Principal Investigator: claudio stacchi, Dr. Piezosurgery Academy

Publications:
Responsible Party: Mr. Claudio Stacchi, DDS, MSc, President of the Academy, International Piezosurgery Academy
ClinicalTrials.gov Identifier: NCT03290729     History of Changes
Other Study ID Numbers: REX_i
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mr. Claudio Stacchi, DDS, MSc, International Piezosurgery Academy:
wedge implants; atrophic bone

Additional relevant MeSH terms:
Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases