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Clinical Trials/NCT01796119
NCT01796119
Completed
Not Applicable

Lateral Alveolar Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery and Threaded Osteotomes for Immediate Implant Placement.

Clinique Dentaire et d'implantologie Dr.Vinh Nguyen1 site in 1 country10 target enrollmentFebruary 2013
ConditionsTooth Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Loss
Sponsor
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
Enrollment
10
Locations
1
Primary Endpoint
Bucco-lingual bone thickness of the alveolar ridge
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
Responsible Party
Principal Investigator
Principal Investigator

Vinh Giap Nguyen, DDS

D.D.S.

Clinique Dentaire et d'implantologie Dr.Vinh Nguyen

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.

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

Outcomes

Primary Outcomes

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 Outcomes

  • To compare BLI measured using PA radiographs(6 months)

Study Sites (1)

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