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Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery

Primary Purpose

Tooth Loss

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ridge Splitting
Implants placed using drilling technique
Sponsored by
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Dental implants, Ridge splitting, Ridge expansion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Systemically healthy
  • Implant therapy will be the elective treatment option.
  • The alveolar ridge thickness will be insufficient to receive implant of 3.5-4.3mm in diameter.
  • The ridge width will be at least 4mm
  • Implants will be placed in the maxillary edentulous ridge from second premolar to the opposite second premolar.
  • There will be a second edentulous ridge in the same individual's mouth that serves as control site. The crest of this site will be at least 5.5mm wide, sufficient to receive an implant of 3.5-4.3 mm in diameter.
  • Demonstrated ability to maintain oral hygiene
  • Willingness and ability to commit to follow-up
  • Able to understand study procedure and provide signed informed consent.
  • In order to ensure optimal efficacy of the methods used to reduce the risk of pregnancy in female subjects and potential harm to a fetus, contraceptive measures are required in order to participate in the Study, as follows: hormonal methods and the IUD must be in used at least 30 days prior to Study drug administration; that barrier methods must be use in used at least 15 days prior to Study drug administration; that vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice.

Exclusion Criteria:

  • Extreme alveolar ridge atrophy with no cancellous bone between the buccal and palatal cortical plates
  • Extensive vertical ridge resorption which requires vertical augmentation
  • Uncontrolled periodontal disease.
  • Need of sinus lift procedures in the site of intended implant placement.
  • Recent febrile illness (within 6 months) that precludes or delays participation
  • Wearers of pacemaker.
  • Severe renal or liver diseases
  • History of radiotherapy of the head and neck region
  • Chemotherapy for treatment of malignant tumors at the time of the study.
  • Immuno-compromised patients
  • Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years.
  • Use of disallowed concomitant medications.
  • Pregnancy or intending to conceive during the course of the Study.

Sites / Locations

  • Clinique Dentaire et d'implantology Dr. Vinh Nguyen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ridge Splitting

Implants placed using drilling technique

Arm Description

Dental implants placed using ridge splitting technique. To measure the horizontal bone width before and after implant insertion and 6 months post-op. To measure BLI measured using PA radiographs taken immediately and 6 months post-op. To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op. To measure implant success rate. The implants used in this study: NobelActive 3.5 - 4.3mm diameter, 10 - 13 mm in length.

Dental implants placed in the ridge with sufficient thickness using drilling technique. To measure the horizontal bone width before and after implant insertion and 6 months post-op. To measure BLI measured using PA radiographs taken immediately and 6 months post-op. To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op. To measure implant success rate. The implants used in this study: NobelActive 3.5-4.3mm diameter, 10 - 13 mm in length.

Outcomes

Primary Outcome Measures

Bucco-lingual bone thickness of the alveolar ridge
To compare the bucco-lingual thickness of the alveolar ridge measured at approximately 1 mm. and 5 mm. below the crestal bone margin, using ridge mapping calipers. These values, measured pre-op, immediately, and 6 months post-op at study site are compared to those measured from controlled site.

Secondary Outcome Measures

To compare BLI measured using PA radiographs
To compare BLI measured using PA radiographs taken immediately, and 6 months post-op at study site. These values are also compared to those measured from controlled site.

Full Information

First Posted
February 18, 2013
Last Updated
February 2, 2015
Sponsor
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
Collaborators
Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT01796119
Brief Title
Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery
Official Title
Lateral Alveolar Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery and Threaded Osteotomes for Immediate Implant Placement.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
Collaborators
Goethe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this split-mouth controlled study, implants placed using the alveolar ridge expansion technique will be compared to those placed in native bone with sufficient horizontal bone width. The Piezosurgery device and Bone expanders (Mectron,Italy) will be employed in an alveolar ridge expansion technique.
Detailed Description
The success rate of endosseous implant placement in native bone has been proven to be highly predictable. Reliable long term result requires sufficient bone thickness surrounding the implant's body. This is especially true in the maxillary aesthetic zone where buccal bone thickness of 2mm or more is necessary to prevent loss of buccal bone margin and maintain the integrity of the gingival architecture. Ridge expansion technique, an alternative to bone graft, widens the alveolar ridge prior to implant placement, thus permits the preservation of buccal and lingual bone thickness. Narrow atrophy edentulous alveolar ridges (study site) in the maxillary aesthetic zone will be split lengthwise using piezo-electric surgery (Piezosurgery, Mectron, USA). The prepared osteotomy will subsequently be expanded using threaded osteotomes (Bone Expanders, Mectron, Italy). Implants will immediately be inserted in the prepared osteotomy. In the edentulous alveolar ridges with sufficient thickness (controlled site) in the maxillary aesthetic zone, implants will be placed directly using conventional drilling technique. Outcome measures will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Dental implants, Ridge splitting, Ridge expansion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ridge Splitting
Arm Type
Experimental
Arm Description
Dental implants placed using ridge splitting technique. To measure the horizontal bone width before and after implant insertion and 6 months post-op. To measure BLI measured using PA radiographs taken immediately and 6 months post-op. To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op. To measure implant success rate. The implants used in this study: NobelActive 3.5 - 4.3mm diameter, 10 - 13 mm in length.
Arm Title
Implants placed using drilling technique
Arm Type
Active Comparator
Arm Description
Dental implants placed in the ridge with sufficient thickness using drilling technique. To measure the horizontal bone width before and after implant insertion and 6 months post-op. To measure BLI measured using PA radiographs taken immediately and 6 months post-op. To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op. To measure implant success rate. The implants used in this study: NobelActive 3.5-4.3mm diameter, 10 - 13 mm in length.
Intervention Type
Procedure
Intervention Name(s)
Ridge Splitting
Intervention Description
To measure the horizontal bone width before and after implant insertion and 6 months post-op. To measure BLI measured using PA radiographs taken immediately and 6 months post-op. To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op. To measure implant success rate. The implants used in this study: NobelActive 3.5 - 4.3mm diameter, 10 - 13 mm in length.
Intervention Type
Procedure
Intervention Name(s)
Implants placed using drilling technique
Intervention Description
To measure the horizontal bone width before and after implant insertion and 6 months post-op. To measure BLI measured using PA radiographs taken immediately and 6 months post-op. To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op. To measure implant success rate. The implants used in this study: NobelActive 3.5-4.3mm diameter, 10 - 13 mm in length.
Primary Outcome Measure Information:
Title
Bucco-lingual bone thickness of the alveolar ridge
Description
To compare the bucco-lingual thickness of the alveolar ridge measured at approximately 1 mm. and 5 mm. below the crestal bone margin, using ridge mapping calipers. These values, measured pre-op, immediately, and 6 months post-op at study site are compared to those measured from controlled site.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To compare BLI measured using PA radiographs
Description
To compare BLI measured using PA radiographs taken immediately, and 6 months post-op at study site. These values are also compared to those measured from controlled site.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Implant Stability Quotient Values
Description
Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately, 3 months and 6 months post-op to evaluate implant stability. These values will also be compared to those obtained from implants placed in controlled site
Time Frame
3, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Systemically healthy Implant therapy will be the elective treatment option. The alveolar ridge thickness will be insufficient to receive implant of 3.5-4.3mm in diameter. The ridge width will be at least 4mm Implants will be placed in the maxillary edentulous ridge from second premolar to the opposite second premolar. There will be a second edentulous ridge in the same individual's mouth that serves as control site. The crest of this site will be at least 5.5mm wide, sufficient to receive an implant of 3.5-4.3 mm in diameter. Demonstrated ability to maintain oral hygiene Willingness and ability to commit to follow-up Able to understand study procedure and provide signed informed consent. In order to ensure optimal efficacy of the methods used to reduce the risk of pregnancy in female subjects and potential harm to a fetus, contraceptive measures are required in order to participate in the Study, as follows: hormonal methods and the IUD must be in used at least 30 days prior to Study drug administration; that barrier methods must be use in used at least 15 days prior to Study drug administration; that vasectomy must be completed 3 months prior to first Study drug administration; or in the alternative that a 0 sperm count will suffice. Exclusion Criteria: Extreme alveolar ridge atrophy with no cancellous bone between the buccal and palatal cortical plates Extensive vertical ridge resorption which requires vertical augmentation Uncontrolled periodontal disease. Need of sinus lift procedures in the site of intended implant placement. Recent febrile illness (within 6 months) that precludes or delays participation Wearers of pacemaker. Severe renal or liver diseases History of radiotherapy of the head and neck region Chemotherapy for treatment of malignant tumors at the time of the study. Immuno-compromised patients Patients on IV bisphosphonates or on long term oral bisphosphonates for more than 3 years. Use of disallowed concomitant medications. Pregnancy or intending to conceive during the course of the Study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinh Nguyen, DDS.
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Dentaire et d'implantology Dr. Vinh Nguyen
City
Brossard
State/Province
Quebec
ZIP/Postal Code
J4W2T4
Country
Canada

12. IPD Sharing Statement

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Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery

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