Impacted ToothNCT05909254
Application of Surgical Templates in the Surgical Exposure of Impacted Canines
A study testing Palatally impacted canine exposure using a surgical guide and Palatally impacted canine exposure using the conventional free.hand method in people with Impacted Tooth, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Impacted Tooth
- What is being tested?
- Palatally impacted canine exposure using a surgical guide and Palatally impacted canine exposure using the conventional free.hand method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 1 May 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University Department of Community Dentistry
Budapest, Budapest, 1088
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Impacted Tooth
- Being tested
- Palatally impacted canine exposure using a surgical guide, Palatally impacted canine exposure using the conventional free.hand method
- Keywords
- surgical exposure, open eruption technique
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatally impacted canine exposure using a surgical guideOther
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.
Palatally impacted canine exposure using the conventional free.hand methodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Palatally impacted canine exposure using a surgical template | Experimental | Not described Receives: Other: Palatally impacted canine exposure using a surgical guide |
| Palatally impacted canine exposure using the conventional free-hand method | Experimental | Not described Receives: Other: Palatally impacted canine exposure using the conventional free.hand method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the intervention
Measures if an attachment could be bonded to the impacted tooth during the surgery.
Measured: on the day of 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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: through study completion, an average of 1 years
Duration of the surgical intervention
Measures the duration of the surgery in minutes.
Measured: during surgery
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.
Measured: 1 week
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.
Measured: through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 May 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted ToothStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marton Kivovics, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909254
- Sponsor's protocol ID
- SEDCD54
- Status last verified
- Apr 2026
- First submitted
- 31 May 2023
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kivovics M, Szanyi SM, Takacs A, Repasi M, Nemeth O, Mijiritsky E. Computer-assisted open exposure of palatally impacted canines for orthodontic eruption: A randomized clinical trial. J Dent. 2024 Aug;147:105110. doi: 10.1016/j.jdent.2024.105110. Epub 2024 Jun 20.
PubMed 38906453
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Surgical Templates in the Surgical Exposure of Impacted Canines
- ClinicalTrials.gov ID
- NCT05909254
- Acronym / sponsor ID
- SEDCD54
- Conditions
- Impacted Tooth
- Keywords
- surgical exposure, open eruption technique
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatally impacted canine exposure using a surgical template | Experimental | Other: Palatally impacted canine exposure using a surgical guide |
| Palatally impacted canine exposure using the conventional free-hand method | Experimental | Other: Palatally impacted canine exposure using the conventional free.hand method |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palatally impacted canine exposure using a surgical guideUnder 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. | Other | Palatally impacted canine exposure using a surgical template |
| Palatally impacted canine exposure using the conventional free.hand methodUnder 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. | Other | Palatally impacted canine exposure using the conventional free-hand method |
Primary outcome
Success of the intervention
Time frame: on the day of the surgery
Measures if an attachment could be bonded to the impacted tooth during the surgery.
Success of the open eruption technique
Time frame: 1 year
Measures whether the canine erupts in its correct place in the dentition following tha application of orthodontic forces.
4 secondary outcomes
Surplus costs of surgical planning and manufacturing the surgical guide
Time frame: through study completion, an average of 1 years
Duration of the surgical intervention
Time frame: during surgery
Postoperative pain
Time frame: 1 week
Intra- and postoperative complications associated with surgery
Time frame: through study completion, an average of 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 38906453Kivovics M, Szanyi SM, Takacs A, Repasi M, Nemeth O, Mijiritsky E. Computer-assisted open exposure of palatally impacted canines for orthodontic eruption: A randomized clinical trial. J Dent. 2024 Aug;147:105110. doi: 10.1016/j.jdent.2024.105110. Epub 2024 Jun 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatally impacted canine exposure using a surgical guide and Palatally impacted canine exposure using the conventional free.hand method in people with Impacted Tooth, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the intervention (time frame: on the day of the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05909254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.