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

NCT01796119 | Completed DMC

• 1 other identifier: IRB1665
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Loss

Keywords

Dental implants, Ridge splitting, Ridge expansion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To compare BLI measured using PA radiographs

  6 months

Other Outcomes (1)

• Implant Stability Quotient Values

  3, 6 months

Study Arms (2)

Ridge Splitting

EXPERIMENTAL

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

Implants placed using drilling technique

ACTIVE COMPARATOR

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

Interventions

Ridge Splitting PROCEDURE

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.

Ridge Splitting

Implants placed using drilling technique PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Dentaire et d'implantologie Dr.Vinh Nguyen: lead
• Goethe University: collaborator

Study Sites (1)

Clinique Dentaire et d'implantology Dr. Vinh Nguyen

Brossard, Quebec, J4W2T4, Canada

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Vinh Nguyen, DDS.

  Goethe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: D.D.S.

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 21, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

CA (1)