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Wedge Implant Narrow Crests: Multi-center Clinical Study

Primary Purpose

Alveolar Bone Loss

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
wedge shape implants insertion
Sponsored by
International Piezosurgery Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring wedge implants; atrophic bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Piezosurgery Academy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

narrow ridge

Arm Description

edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion

Outcomes

Primary Outcome Measures

implant survival rate
health of the inserted implants

Secondary Outcome Measures

surgical procedure evaluation
handling assessment of the implant system by the surgeons
surgical procedure evaluation
assessment of the invasivity of the surgical procedure from the patient
implant stability 14
resonance frequence analysis of the implant
implant stability 1 month
resonance frequence analysis of the implant
implant stability 2 months
resonance frequence analysis of the implant
implant stability 3 months
resonance frequence analysis of the implant
implant stability 4 months
resonance frequence analysis of the implant
implant stability 5 months
resonance frequence analysis of the implant
implant stability 6 months
resonance frequence analysis of the implant
implant stability 1 year
resonance frequence analysis of the implant
implant stability 3 years
resonance frequence analysis of the implant
implant stability 5 years
resonance frequence analysis of the implant

Full Information

First Posted
July 21, 2017
Last Updated
August 25, 2020
Sponsor
International Piezosurgery Academy
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1. Study Identification

Unique Protocol Identification Number
NCT03290729
Brief Title
Wedge Implant Narrow Crests: Multi-center Clinical Study
Official Title
Wedge Implant for Minimally Invasive Treatment of Narrow Crests: a Prospective Multi-center Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Piezosurgery Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
Keywords
wedge implants; atrophic bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multicenter single cohort prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
narrow ridge
Arm Type
Experimental
Arm Description
edentulous site with crestal bone width comprised between 3,5 and 5 millimeters wedge shape implants insertion
Intervention Type
Procedure
Intervention Name(s)
wedge shape implants insertion
Intervention Description
Narrow dental implants inserted in narrow ridges
Primary Outcome Measure Information:
Title
implant survival rate
Description
health of the inserted implants
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
surgical procedure evaluation
Description
handling assessment of the implant system by the surgeons
Time Frame
during surgery
Title
surgical procedure evaluation
Description
assessment of the invasivity of the surgical procedure from the patient
Time Frame
1 hour after surgery
Title
implant stability 14
Description
resonance frequence analysis of the implant
Time Frame
14 days after surgery
Title
implant stability 1 month
Description
resonance frequence analysis of the implant
Time Frame
1 month after surgery
Title
implant stability 2 months
Description
resonance frequence analysis of the implant
Time Frame
2 months after surgery
Title
implant stability 3 months
Description
resonance frequence analysis of the implant
Time Frame
3 months after surgery
Title
implant stability 4 months
Description
resonance frequence analysis of the implant
Time Frame
4 months after surgery
Title
implant stability 5 months
Description
resonance frequence analysis of the implant
Time Frame
5 months after surgery
Title
implant stability 6 months
Description
resonance frequence analysis of the implant
Time Frame
6 months after surgery
Title
implant stability 1 year
Description
resonance frequence analysis of the implant
Time Frame
1 year after surgery
Title
implant stability 3 years
Description
resonance frequence analysis of the implant
Time Frame
3 years after surgery
Title
implant stability 5 years
Description
resonance frequence analysis of the implant
Time Frame
5 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: indications for prosthetic rehabilitation supported by implants in the upper or lower arch, based on accurate diagnosis and treatment planning; the bone crest must be completely healed (at least six months after the tooth loss); residual bone ridge width between 3.5 and 5 mm, at least 3 mm in apical direction; presence of at least 10 mm bone height available for implant placement; age of the patient> 18 years; The patient must not carry any removable prosthesis on the treated area; the patient must be able to follow the protocol of study; informed written consent Exclusion Criteria: acute myocardial infarction over the last 2 months; uncontrolled coagulation disorders; unmanaged diabetes (HBA1c> 7.5); radiotherapy to the head area in the last 24 months; immunocompromised, HIV positive or chemotherapy patients over the past 5 years; present or past treatment with intravenous bisphosphonates; psychological or psychiatric problems; abuse of alcohol or drugs; uncontrolled periodontal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
claudio stacchi, Dr.
Organizational Affiliation
Piezosurgery Academy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piezosurgery Academy
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19663958
Citation
Chiapasco M, Zaniboni M. Clinical outcomes of GBR procedures to correct peri-implant dehiscences and fenestrations: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:113-23. doi: 10.1111/j.1600-0501.2009.01781.x.
Results Reference
background
PubMed Identifier
19837318
Citation
Danza M, Guidi R, Carinci F. Comparison between implants inserted into piezo split and unsplit alveolar crests. J Oral Maxillofac Surg. 2009 Nov;67(11):2460-5. doi: 10.1016/j.joms.2009.04.041.
Results Reference
background
PubMed Identifier
12956475
Citation
Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23.
Results Reference
background

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Wedge Implant Narrow Crests: Multi-center Clinical Study

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