Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation

March 31, 2024 updated by: National Taiwan University Hospital

Bone quality stands as a crucial determinant impacting the success rate of dental implants, exerting influence on both implant primary stability and the efficacy of osseointegration. While radiographic images can partially reveal bone quality, experienced surgeons often rely on tactile sensation during bone drilling to assess it. Subsequently, based on the diagnosed bone quality, distinct implant designs and surgical protocols have been invented to enhance survival rates.

Technological advancements now enable the preoperative design of implant placement through a comprehensive guide, merging CBCT DICOM files with digital oral scanning data. This "fully guided" approach enhances the precision, stability, and safety of implant placement surgery. However, the use of a fully guided surgical guide introduces an additional factor-the friction between the drill and guide-potentially impacting the surgeon's tactile feedback.

This study aims to assess the difference in bone quality evaluation by tactile sensation between freehand drilling and drilling with a fully guided surgical guide, using test blocks of different bone density. The discussion will explore the pros and cons of employing a fully guided guide to optimize outcomes in implant treatment.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The pilot study involves five subjects, while the main experiment will include thirty subjects. The experiment consists of two rounds, each with seven simulated bone samples. These samples include four different densities (5pcf, 5pcf, 10pcf, 10pcf, 15pcf, 15pcf, 30pcf) tested in random order. Before each round of testing, participants drill into a 50 pcf bone sample and identifying it as the hardest scale. The experiment then commences with the first round employing conventional drilling tests, followed by the second round drilling with a fully guided surgical template. After each drilling session, participants assess the hardness by recording a VAS score on a 10cm scale. The evaluation criteria utilize VAS scores as the measurement tool. The aim of this experiment is to investigate whether there are differences in the classification of bone density judged by using a fully guided surgical template compared to judgments made without using the template, under the same bone density conditions. Additionally, the study aims to determine if the use of the template affects the accuracy of bone density assessment.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Board-certified dentist with age over 24 to 40 years old who has practice within 10 years and experience of Implant surgery should be less than 10 implants

Description

Inclusion Criteria:

  1. Board-certified dentist
  2. Practice within 10 years
  3. Experience of Implant surgery should be less than 10 implants
  4. Age: 24-40 y

Exclusion Criteria:

1. Unable to follow the entire test

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
VAS scale at the same density of sawbone
Time Frame: From admission to discharge, up to 1 year
To compare the VAS scale at the same density of sawbone between free-hand drilling and drilling with fully guided stent.
From admission to discharge, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: wang tongmei, National Taiwan University

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 (Estimated)

March 31, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202401078RINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study participants only sign for this study. The personal data is promised to them should be private.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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