Status:
COMPLETED
Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery
Lead Sponsor:
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
Collaborating Sponsors:
Goethe University
Conditions:
Tooth Loss
Eligibility:
All Genders
18-90 years
Phase:
NA
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 Piezosurg...
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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01796119
Start Date
February 1 2013
End Date
February 1 2014
Last Update
February 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinique Dentaire et d'implantology Dr. Vinh Nguyen
Brossard, Quebec, Canada, J4W2T4