Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05909254
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-05-31
Brief Title:
Application of Surgical Templates in the Surgical Exposure of Impacted Canines
Sponsor:
Semmelweis University
Organization:
Semmelweis University
Study Overview
Official Title:
Application of Surgical Templates in the Surgical Exposure of Impacted Canines
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The first choice therapy in case of palatally impacted canines is their exposure and orthodontic eruption to improve facial esthetics and prevent pathologies associated with impacted teeth and Temporomandibular Joint Disorders Current solutions in digital dentistry allow the registration of three dimensional imaging datasets such as cone beam computed tomography CBCT and digital impression of the dentition and soft tissues obtained via intraoral scanning using orthodontic planning software This allows the surgeon to visualize the position of the impacted canine prior to surgery and to design and manufacture a surgical guide to aid in the localization of the impacted tooth during surgery
The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure
Patients included in this study are randomly assigned to two study groups In Group 1 surgical exposure for open eruption of palatally impacted canines is performed following virtual planning using a surgical template In Group 2 surgical exposure for open-eruption of palatally impacted canines is carried out using the conventional free-hand method
We hypothesize that guided exposure of the impacted canines will be as successful as the conventional method with shorter surgical intervention and higher associated costs
The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure
Patients included in this study are randomly assigned to two study groups In Group 1 surgical exposure for open eruption of palatally impacted canines is performed following virtual planning using a surgical template In Group 2 surgical exposure for open-eruption of palatally impacted canines is carried out using the conventional free-hand method
We hypothesize that guided exposure of the impacted canines will be as successful as the conventional method with shorter surgical intervention and higher associated costs
Detailed Description:
Objectives The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure Our null-hypothesis is that there will be no significant differences in the outcome measures between the two methods
Materials and methods
Groups
Group 1 test group Surgical exposure for open eruption of palatally impacted canines following virtual planning using a surgical template
Group 2 control group Surgical exposure for open-eruption of palatally impacted canines using the conventional free-hand method
Simple randomization is performed to determine whether patients are included in the test or control group 20 patients are recruited per group During continuous recruiting sample size calculation is to be carried out to determine the actual number of patients included in this study
Surgical planning The upper jaw of the patient is scanned using an intraoral scanner IOS Trios 4 3Shape Copenhagen Denmark Cone beam tomography CBCT scans Green X Vatech Hwaseong Korea are performed before surgical exposure to assess the position angulation possible dilaceration and bone coverage of the impacted canines The scanning conditions are constant at 200 μm isotropic voxel size with 360 rotation 94 kiloVolt kV tube voltage 72 miliAmper mA tube current and 9 s exposure time with a field of view of 15 8 cm In the test group OnyxCeph³ software is used to register the standard tessellation language STL file of the digital impression with the Digital Imaging and Communications in Medicine DICOM data of the pre-operative CBCT reconstruction by surface registration A surgical template is designed to cover the palate incisal and occlusal surfaces of the dentition with an opening that outlines the window to be prepared to expose the impacted canine Fused deposition modeling FDM is used for the rapid prototyping of the surgical template FlashForge Creator Pro 4 Zhejiang Flashforge 3D Technology Co Ltd Jinhua City China using polylactic acid filament PLA
Surgery In both groups patients rinse their oral cavity with 02 chlorhexidine solution for 1 min before surgery and surgical interventions are performed under local anesthesia In the test group the fit of the surgical template is a checked and a surgical laser SiroLaser Blue Dentsply Sirona Charlotte North Carolina USA is used for the exposure of the impacted canine In the control group the surgeon relies on the surgical plan and their experience to localize the impacted canine The attachment is bonded to the exposed canine by an orthodontist Patients are instructed to clean the wound using toothpaste and toothbrush and to rinse with 02 chlorhexidine solution in the morning and in the evening for a week starting on the day after surgery Anti-inflammatory drugs 25 mg diclofenac three times a day for 3 days are prescribed to control postoperative pain
Management of participant-bias Surgical planning and interventions are performed by a skilled surgeon The clinician performing the exposure of the impacted canine is not involved in the evaluation of the outcome measures The examiner carrying out the measurement of the outcome variables was blinded to the surgical modality used during surgery
Materials and methods
Groups
Group 1 test group Surgical exposure for open eruption of palatally impacted canines following virtual planning using a surgical template
Group 2 control group Surgical exposure for open-eruption of palatally impacted canines using the conventional free-hand method
Simple randomization is performed to determine whether patients are included in the test or control group 20 patients are recruited per group During continuous recruiting sample size calculation is to be carried out to determine the actual number of patients included in this study
Surgical planning The upper jaw of the patient is scanned using an intraoral scanner IOS Trios 4 3Shape Copenhagen Denmark Cone beam tomography CBCT scans Green X Vatech Hwaseong Korea are performed before surgical exposure to assess the position angulation possible dilaceration and bone coverage of the impacted canines The scanning conditions are constant at 200 μm isotropic voxel size with 360 rotation 94 kiloVolt kV tube voltage 72 miliAmper mA tube current and 9 s exposure time with a field of view of 15 8 cm In the test group OnyxCeph³ software is used to register the standard tessellation language STL file of the digital impression with the Digital Imaging and Communications in Medicine DICOM data of the pre-operative CBCT reconstruction by surface registration A surgical template is designed to cover the palate incisal and occlusal surfaces of the dentition with an opening that outlines the window to be prepared to expose the impacted canine Fused deposition modeling FDM is used for the rapid prototyping of the surgical template FlashForge Creator Pro 4 Zhejiang Flashforge 3D Technology Co Ltd Jinhua City China using polylactic acid filament PLA
Surgery In both groups patients rinse their oral cavity with 02 chlorhexidine solution for 1 min before surgery and surgical interventions are performed under local anesthesia In the test group the fit of the surgical template is a checked and a surgical laser SiroLaser Blue Dentsply Sirona Charlotte North Carolina USA is used for the exposure of the impacted canine In the control group the surgeon relies on the surgical plan and their experience to localize the impacted canine The attachment is bonded to the exposed canine by an orthodontist Patients are instructed to clean the wound using toothpaste and toothbrush and to rinse with 02 chlorhexidine solution in the morning and in the evening for a week starting on the day after surgery Anti-inflammatory drugs 25 mg diclofenac three times a day for 3 days are prescribed to control postoperative pain
Management of participant-bias Surgical planning and interventions are performed by a skilled surgeon The clinician performing the exposure of the impacted canine is not involved in the evaluation of the outcome measures The examiner carrying out the measurement of the outcome variables was blinded to the surgical modality used during surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None