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

Tooth Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796119
• Other study ID #: IRB1665
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: February 2, 2015
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tooth Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Clinique Dentaire et d'implantology Dr. Vinh Nguyen	Brossard	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Dentaire et d'implantologie Dr.Vinh Nguyen	Goethe University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implant Stability Quotient Values	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	3, 6 months	No
Primary	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.	6 months	No
Secondary	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.	6 months	No