- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307798
Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery (SBTP)
October 11, 2017 updated by: National Taiwan University Hospital
Bone quality is one of the major factors influencing the dental implant survival rate.
Bone quality is believed to have effects on initial implant stability and success of osseointegration.
Different implant designs and surgical protocols were developed for improving the survival rate in different bone quality.
Although bone quality can be partly diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality with tactile sensation when they drill the bone.
However, variations in evaluation of bone density maybe exist among different surgeons.
For less experienced dentists, it is difficult to diagnose bone quality with tactile sensation in the beginning.
This purpose of this study is to evaluate a training protocol in using tactile sensation to classify bone quality during implant surgery.
Saw bones of variant densities are used as training materials.
The outcomes before and after training will be compared.
The effect of training frequency before surgery will also be evaluated.
Study Overview
Status
Unknown
Detailed Description
Twenty-five dentists will be enrolled into the study.
Tests will be performed using visual analog scale to score bone quality of test blocks.
Study Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Li-Deh Lin, DDS, PhD
- Phone Number: 66864 886223123456
- Email: lidehlin@ntu.edu.tw
-
Contact:
- Tong-Mei Wang, PHD
- Phone Number: 66864 886223123456
- Email: tongmeiwang@ntu.edu.tw
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Dentists in Taiwan
Description
Inclusion Criteria:
- Certified dentist with implant surgery experience less than 10 implants.
Exclusion Criteria:
- Age exceed the limits
- Implant surgery experience more or equal to 10 implants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on visual analog scale (VAS) score of each test block
Time Frame: 1st time point: test before training & test immediately after training; 2nd time point: 1 week after 1st time point (test after 1 wk); 3rd time point: 1 month after 2nd time point (test after 1month)
|
Each VAS score performed on the specific test block will be compared between different time point.
|
1st time point: test before training & test immediately after training; 2nd time point: 1 week after 1st time point (test after 1 wk); 3rd time point: 1 month after 2nd time point (test after 1month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tong-Mei Wang Wang, DDS, MS, PhD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Friberg B, Sennerby L, Meredith N, Lekholm U. A comparison between cutting torque and resonance frequency measurements of maxillary implants. A 20-month clinical study. Int J Oral Maxillofac Surg. 1999 Aug;28(4):297-303.
- Johansson P, Strid KG. Assessment of bone quality from cutting resistance during implant surgery. Internatioanl Journal of Oral & Maxillofacial implants 9:279-288, 1994
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2017
Primary Completion (Anticipated)
August 31, 2018
Study Completion (Anticipated)
August 31, 2018
Study Registration Dates
First Submitted
September 21, 2017
First Submitted That Met QC Criteria
October 11, 2017
First Posted (Actual)
October 12, 2017
Study Record Updates
Last Update Posted (Actual)
October 12, 2017
Last Update Submitted That Met QC Criteria
October 11, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201612189RIND
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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