search
Back to results

Application of Surgical Templates in the Surgical Exposure of Impacted Canines

Primary Purpose

Impacted Tooth

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Palatally impacted canine exposure using a surgical guide
Palatally impacted canine exposure using the conventional free.hand method
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Tooth focused on measuring surgical exposure, open eruption technique

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients between the age of 11-18 of the Department of Community Dentistry, Semmelweis University, who need surgical exposure and orthodontic eruption of their palatally impacted canines on one or both sides during their orthodontic treatment are included in this study. Exclusion Criteria: Uncontrolled systemic diseases that contraindicate orthodontic treatment or minor dental surgery, Trauma in the patient's history in the vicinity of the surgical site. Dental abnormalities (hyperdontia, hypodontia, etc.), Congenital craniofacial disorders, Permanent teeth extraction-based treatment, Periodontal disease, Cases in which the canine is to be brought into the position of the lateral incisor, Agenesis of lateral incisors on the impaction side, Documented learning disability, Insufficient oral hygiene, and Non-compliance during the combined orthodontic-surgical treatment. Smoking

Sites / Locations

  • Semmelweis University Department of Community DentistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Palatally impacted canine exposure using a surgical template

Palatally impacted canine exposure using the conventional free-hand method

Arm Description

Outcomes

Primary Outcome Measures

Success of the intervention
Measures if an attachment could be bonded to the impacted tooth during the surgery.
Success of the open eruption technique
Measures whether the canine erupts in its correct place in the dentition following tha application of orthodontic forces.

Secondary Outcome Measures

Surplus costs of surgical planning and manufacturing the surgical guide
Measures the excess costs of the design and manufacture of surgical guides used in Euro.
Duration of the surgical intervention
Measures the duration of the surgery in minutes.
Postoperative pain
Pain and recovery reported by the patient after surgery, measured on 100 mm visual analog scale (VAS) on the evening of the intervention and in the following 7 days. 0 is the lowest score, which means that the patient experienced no pain at all following surgery, 100 is the highest score refering to the worst pain the patient had ever experienced previously.
Intra- and postoperative complications associated with surgery
Number of cases where bleeding, damage to neighboring teeth, roots, and anatomical structures, nerve damage, antro-oral communication or fistula, inflammation is observed during follow up.

Full Information

First Posted
May 31, 2023
Last Updated
June 9, 2023
Sponsor
Semmelweis University
search

1. Study Identification

Unique Protocol Identification Number
NCT05909254
Brief Title
Application of Surgical Templates in the Surgical Exposure of Impacted Canines
Official Title
Application of Surgical Templates in the Surgical Exposure of Impacted Canines
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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, 7.2 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 0.2% 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, U.S.A.) 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 0.2% 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Tooth
Keywords
surgical exposure, open eruption technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palatally impacted canine exposure using a surgical template
Arm Type
Experimental
Arm Title
Palatally impacted canine exposure using the conventional free-hand method
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Palatally impacted canine exposure using a surgical guide
Intervention Description
Under local anaesthesia the tissues covering the palatally impacted canine are removed with the help of a surgical guide to expose the tooth, to allow the bonding of an attachment on its surface for orthodontic traction.
Intervention Type
Other
Intervention Name(s)
Palatally impacted canine exposure using the conventional free.hand method
Intervention Description
Under local anaesthesia the tissues covering the palatally impacted canine are removed to expose the tooth, to allow the bonding of an attachment on its surface for orthodontic traction. The surgeon relies on the surgical plan and their experience to localize the impacted canine.
Primary Outcome Measure Information:
Title
Success of the intervention
Description
Measures if an attachment could be bonded to the impacted tooth during the surgery.
Time Frame
on the day of the surgery
Title
Success of the open eruption technique
Description
Measures whether the canine erupts in its correct place in the dentition following tha application of orthodontic forces.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Surplus costs of surgical planning and manufacturing the surgical guide
Description
Measures the excess costs of the design and manufacture of surgical guides used in Euro.
Time Frame
through study completion, an average of 1 years
Title
Duration of the surgical intervention
Description
Measures the duration of the surgery in minutes.
Time Frame
during surgery
Title
Postoperative pain
Description
Pain and recovery reported by the patient after surgery, measured on 100 mm visual analog scale (VAS) on the evening of the intervention and in the following 7 days. 0 is the lowest score, which means that the patient experienced no pain at all following surgery, 100 is the highest score refering to the worst pain the patient had ever experienced previously.
Time Frame
1 week
Title
Intra- and postoperative complications associated with surgery
Description
Number of cases where bleeding, damage to neighboring teeth, roots, and anatomical structures, nerve damage, antro-oral communication or fistula, inflammation is observed during follow up.
Time Frame
through study completion, an average of 1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the age of 11-18 of the Department of Community Dentistry, Semmelweis University, who need surgical exposure and orthodontic eruption of their palatally impacted canines on one or both sides during their orthodontic treatment are included in this study. Exclusion Criteria: Uncontrolled systemic diseases that contraindicate orthodontic treatment or minor dental surgery, Trauma in the patient's history in the vicinity of the surgical site. Dental abnormalities (hyperdontia, hypodontia, etc.), Congenital craniofacial disorders, Permanent teeth extraction-based treatment, Periodontal disease, Cases in which the canine is to be brought into the position of the lateral incisor, Agenesis of lateral incisors on the impaction side, Documented learning disability, Insufficient oral hygiene, and Non-compliance during the combined orthodontic-surgical treatment. Smoking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Márton Kivovics, DMD, MSD, PhD
Phone
0036303601909
Email
kivovics.marton@dent.semmelweis-univ.hu
Facility Information:
Facility Name
Semmelweis University Department of Community Dentistry
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Márton Kivovics, DMD MSc PhD
Phone
0036303780476
Email
kivovics.marton@dent.semmelweis-univ.hu
First Name & Middle Initial & Last Name & Degree
Dorottya Pénzes, DMD MSc
Email
penzes.dorottya@dent.semmelweis-univ.hu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Application of Surgical Templates in the Surgical Exposure of Impacted Canines

We'll reach out to this number within 24 hrs