Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery

Surgery Clinical Trial

— SBTP  

Official title:

Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03307798
• Other study ID #: 201612189RIND
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2017
• Last updated: October 11, 2017
• Start date: September 20, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: March 2017
• Source: National Taiwan University Hospital
• Contact: Tong-Mei Wang, DDS, MS, PhD
• Phone: 886223123456
• Email: tongmeiwang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis of Bone Quality
• Surgery
• Training Tactile Sensation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

Johansson P, Strid KG. Assessment of bone quality from cutting resistance during implant surgery. Internatioanl Journal of Oral & Maxillofacial implants 9:279-288, 1994

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on visual analog scale (VAS) score of each test block	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)