NCT03307798

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 21, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

October 12, 2017

Status Verified

March 1, 2017

Enrollment Period

12 months

First QC Date

September 21, 2017

Last Update Submit

October 11, 2017

Conditions

Keywords

dental implant,bone quality,tactile sensation

Outcome Measures

Primary Outcomes (1)

  • 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)

Eligibility Criteria

Age26 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Dentists in Taiwan

You may qualify if:

  • Certified dentist with implant surgery experience less than 10 implants.

You may not qualify if:

  • Age exceed the limits
  • Implant surgery experience more or equal to 10 implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related 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.

    PMID: 10416900BACKGROUND
  • Johansson P, Strid KG. Assessment of bone quality from cutting resistance during implant surgery. Internatioanl Journal of Oral & Maxillofacial implants 9:279-288, 1994

    BACKGROUND

Study Officials

  • Tong-Mei Wang Wang, DDS, MS, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tong-Mei Wang, DDS, MS, PhD

CONTACT

Li-Deh Lin, DDS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 12, 2017

Study Start

September 20, 2017

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

October 12, 2017

Record last verified: 2017-03

Locations