Clinical trial NCT03307798: Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery
Official title: Evaluate a Saw Bone Training Protocol in Using Tactile Sensation to Classify Bone Quality During Implant Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Training Tactile Sensation
Diagnosis of Bone Quality
Keywords: dental implant,bone quality,tactile sensation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 25
Sex: ALL
Minimum age (years): 26
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dentists in Taiwan

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on visual analog scale (VAS) score of each test block
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Tong-Mei Wang Wang, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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