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

Study 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.

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

Conditions
-----------------
Tooth Loss

Intervention / Treatment
-----------------
* Procedure: Ridge Splitting
* Procedure: Implants placed using drilling technique


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ridge Splitting<br>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<br>* 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.<br>|
| Active Comparator: Implants placed using drilling technique<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental implants, Ridge splitting, Ridge expansion