Jaw, Edentulous, PartiallyNCT00172718
Using 3.3mm Screw Tap and Cutting Resistance to Evaluate Bone Quality Around Dental Implant
An observational study of Jaw, Edentulous, Partially and Mouth, Edentulous, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Mouth, Edentulous
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2005to not given
- Phase
- Observational
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No major systemic diseases
- Mouth opening: > 35 mm
- Missing teeth at anterior or premolar area and willing to restored by implantation
Who cannot join
- Uncomfortable or other condition occurring in the surgical procedure make the measuring unacceptable
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dept. of Dentistry, National Taiwan University Hospital
Taipei, 100
Tong-Mei Wang, DDS, MS, 886-2-23123456 ext. 6864, tongmei@ha.mc.ntu.edu.tw
About this study
Official title: Using 3.3mm Screw Tap to Modify the Standard Implantation Procedure and to Measure the Cutting Resistance for Establishing a More Objective Method to Evaluate the Peri-Implant Bone Quality
Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. The reasons are believed that poor bone quality reduces the initial stability of dental implants and then reduces the success rate. For increasing initial stability of dental implants, some technical modifications are suggested in literature. However, due to lack of an objective method to evaluate bone quality, they are controversial. The purposes of this clinical study are to develop a standard procedure which using cutting resistance measured by Osseocare in surgery to evaluate the bone quality and to compare with the clinical experiences of oral surgeons. The objective outcome, initial stability of dental implant, is measured with Osstell. The analyzed results are also helpful for less experienced surgeons.
Read the detailed description
Materials \& Methods:
- Patient eligibility: Six implant surgeons will assist the experiment. The subjects are patient who will receive dental implant treatment in Dental department of NTUH. Sixty subjects are offered by six surgeons. They must fully fill the requirements as following
- Conditions
- Jaw, Edentulous, Partially, Mouth, Edentulous
- Medical subject headings
- Jaw, Edentulous, Partially, Mouth, Edentulous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tong-Mei Wang, DDS, MS, Principal investigator, National Taiwan University, School of DentistryLi-Deh Lin, DDS, PhD, Study director, National Taiwan University, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172718
- Sponsor's protocol ID
- 9361701264
- Status last verified
- Feb 2005
- First submitted
- 12 Sep 2005
- Last updated
- 6 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using 3.3mm Screw Tap to Modify the Standard Implantation Procedure and to Measure the Cutting Resistance for Establishing a More Objective Method to Evaluate the Peri-Implant Bone Quality
- ClinicalTrials.gov ID
- NCT00172718
- Acronym / sponsor ID
- 9361701264
- Conditions
- Jaw, Edentulous, Partially, Mouth, Edentulous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- First posted
- 15 Sep 2005 (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.
Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. The reasons are believed that poor bone quality reduces the initial stability of dental implants and then reduces the success rate. For increasing initial stability of dental implants, some technical modifications are suggested in literature. However, due to lack of an objective method to evaluate bone quality, they are controversial. The purposes of this clinical study are to develop a standard procedure which using cutting resistance measured by Osseocare in surgery to evaluate the bone quality and to compare with the clinical experiences of oral surgeons. The objective outcome, initial stability of dental implant, is measured with Osstell. The analyzed results are also helpful for less experienced surgeons.
Detailed description
Materials \& Methods:
- Patient eligibility: Six implant surgeons will assist the experiment. The subjects are patient who will receive dental implant treatment in Dental department of NTUH. Sixty subjects are offered by six surgeons. They must fully fill the requirements as following
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No major systemic diseases
- Mouth opening: > 35 mm
- Missing teeth at anterior or premolar area and willing to restored by implantation
Key exclusion criteria (1 listed)
- Uncomfortable or other condition occurring in the surgical procedure make the measuring unacceptable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2008.
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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.
Tong-Mei Wang, DDS, MS principal investigator
National Taiwan University, School of Dentistry
Li-Deh Lin, DDS, PhD study director
National Taiwan University, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jaw, Edentulous, Partially and Mouth, Edentulous, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Jun 2008. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tong-Mei Wang, DDS, MS (886-2-23123456 ext. 6864, tongmei@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 6 Jun 2008.