Clinical trial NCT06349421: Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
Official title: Exploring the Impact of Fully Guided Implant Placement on Classifying Bone Quality Through Tactile Sensation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dentistry
Education
Keywords: dental implant
bone quality
tactile sensation
fully guided surgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS scale at the same density of sawbone
timeFrame: From admission to discharge, up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taiwan National University
Study officials:
affiliation: National Taiwan University
name: wang tongmei
role: STUDY_CHAIR
References: