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 : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Bone Loss||Procedure: wedge shape implants insertion||Not Applicable|
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)|
|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, 2019|
|Estimated Study Completion Date :||May 15, 2023|
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
- implant survival rate [ Time Frame: 1 year after surgery ]health of the inserted implants
- surgical procedure evaluation [ Time Frame: during surgery ]handling assessment of the implant system by the surgeons
- surgical procedure evaluation [ Time Frame: 1 hour after surgery ]assessment of the invasivity of the surgical procedure from the patient
- implant stability 14 [ Time Frame: 14 days after surgery ]resonance frequence analysis of the implant
- implant stability 1 month [ Time Frame: 1 month after surgery ]resonance frequence analysis of the implant
- implant stability 2 months [ Time Frame: 2 months after surgery ]resonance frequence analysis of the implant
- implant stability 3 months [ Time Frame: 3 months after surgery ]resonance frequence analysis of the implant
- implant stability 4 months [ Time Frame: 4 months after surgery ]resonance frequence analysis of the implant
- implant stability 5 months [ Time Frame: 5 months after surgery ]resonance frequence analysis of the implant
- implant stability 6 months [ Time Frame: 6 months after surgery ]resonance frequence analysis of the implant
- implant stability 1 year [ Time Frame: 1 year after surgery ]resonance frequence analysis of the implant
- implant stability 3 years [ Time Frame: 3 years after surgery ]resonance frequence analysis of the implant
- implant stability 5 years [ Time Frame: 5 years after surgery ]resonance frequence analysis of the implant
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
|Contact: claudio stacchi, Dr||0403992020 ext email@example.com|
|Contact: teresa lombardi, Dr.||098171692 ext firstname.lastname@example.org|
|Parma, PR, Italy, 43100|
|Contact: Claudio Stacchi, Dr. 0403992020 ext 0039 email@example.com|
|Contact: Teresa Lombardi, Dr. 098171692 ext 0039 firstname.lastname@example.org|
|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.|
|Principal Investigator:||claudio stacchi, Dr.||Piezosurgery Academy|