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

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ClinicalTrials.gov Identifier: NCT01796119
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : February 4, 2015
Sponsor:
Collaborator:
Goethe University
Information provided by (Responsible Party):
Vinh Giap Nguyen, DDS, Clinique Dentaire et d'implantologie Dr.Vinh Nguyen

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.


Condition or disease Intervention/treatment Phase
Tooth Loss Procedure: Ridge Splitting Procedure: Implants placed using drilling technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lateral Alveolar Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery and Threaded Osteotomes for Immediate Implant Placement.
Study Start Date : February 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Ridge Splitting

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.

Procedure: Ridge Splitting

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.


Active Comparator: Implants placed using drilling technique

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.

Procedure: Implants placed 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.





Primary Outcome Measures :
  1. Bucco-lingual bone thickness of the alveolar ridge [ Time Frame: 6 months ]
    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 :
  1. To compare BLI measured using PA radiographs [ Time Frame: 6 months ]
    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.


Other Outcome Measures:
  1. Implant Stability Quotient Values [ Time Frame: 3, 6 months ]
    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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT01796119


Locations
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Canada, Quebec
Clinique Dentaire et d'implantology Dr. Vinh Nguyen
Brossard, Quebec, Canada, J4W2T4
Sponsors and Collaborators
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
Goethe University
Investigators
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Principal Investigator: Vinh Nguyen, DDS. Goethe University

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Responsible Party: Vinh Giap Nguyen, DDS, D.D.S., Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
ClinicalTrials.gov Identifier: NCT01796119     History of Changes
Other Study ID Numbers: IRB1665
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015

Keywords provided by Vinh Giap Nguyen, DDS, Clinique Dentaire et d'implantologie Dr.Vinh Nguyen:
Dental implants, Ridge splitting, Ridge expansion

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases