NCT06349421

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

May 8, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

March 31, 2024

Last Update Submit

May 6, 2024

Conditions

Keywords

dental implantbone qualitytactile sensationfully guided surgery

Outcome Measures

Primary Outcomes (1)

  • VAS scale at the same density of sawbone

    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

Eligibility Criteria

Age24 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • Board-certified dentist
  • Practice within 10 years
  • Experience of Implant surgery should be less than 10 implants
  • Age: 24-40 y

You may not qualify if:

  • \. Unable to follow the entire test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan National University

Taipei County, Taiwan

RECRUITING

Study Officials

  • wang tongmei

    National Taiwan University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 5, 2024

Study Start

April 1, 2024

Primary Completion

October 15, 2024

Study Completion

October 15, 2024

Last Updated

May 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

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

Locations