Tooth LossNCT01796119
Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery
A study testing Ridge Splitting and Implants placed using drilling technique in people with Tooth Loss, run by Clinique Dentaire et d'implantologie Dr.Vinh Nguyen at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Ridge Splitting and Implants placed using drilling technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique Dentaire et d'implantology Dr. Vinh Nguyen
Brossard, Quebec, J4W2T4
About this study
Official title: Lateral Alveolar Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery and Threaded Osteotomes for Immediate Implant Placement.
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.
Read the 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.
- Conditions
- Tooth Loss
- Being tested
- Ridge Splitting, Implants placed using drilling technique
- Keywords
- Dental implants, Ridge splitting, Ridge expansion
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge SplittingProcedure or surgery
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Implants placed using drilling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University
- Responsible party
- Principal investigator, Vinh Giap Nguyen, DDS, Clinique Dentaire et d'implantologie Dr.Vinh Nguyen
- Investigators
- Vinh Nguyen, DDS., Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796119
- Sponsor's protocol ID
- IRB1665
- Status last verified
- Feb 2015
- First submitted
- 18 Feb 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Alveolar Ridge Expansion in the Maxillary Aesthetic Zone Using Piezo-electric Surgery and Threaded Osteotomes for Immediate Implant Placement.
- ClinicalTrials.gov ID
- NCT01796119
- Acronym / sponsor ID
- IRB1665
- Conditions
- Tooth Loss
- Keywords
- Dental implants, Ridge splitting, Ridge expansion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clinique Dentaire et d'implantologie Dr.Vinh NguyenUniversity, hospital or other
- Collaborators
- Goethe University
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ridge Splitting | Experimental | Procedure: Ridge SplittingDental 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. |
| Implants placed using drilling technique | Active comparator | Procedure: Implants placed using drilling techniqueDental 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ridge SplittingTo 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 or surgery | Ridge Splitting |
| Implants placed using drilling techniqueTo 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 or surgery | Implants placed using drilling technique |
Primary outcome
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.
1 secondary outcome
To compare BLI measured using PA radiographs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinh Nguyen, DDS. principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge Splitting and Implants placed using drilling technique in people with Tooth Loss, run by Clinique Dentaire et d'implantologie Dr.Vinh Nguyen at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bucco-lingual bone thickness of the alveolar ridge (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.