Application of Surgical Templates in the Surgical Exposure of Impacted Canines
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
May 31, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 22, 2026
April 1, 2026
5 years
May 31, 2023
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Success of the intervention
Measures if an attachment could be bonded to the impacted tooth during the surgery.
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.
1 year
Secondary Outcomes (4)
Surplus costs of surgical planning and manufacturing the surgical guide
through study completion, an average of 1 years
Duration of the surgical intervention
during surgery
Postoperative pain
1 week
Intra- and postoperative complications associated with surgery
through study completion, an average of 1 years
Study Arms (2)
Palatally impacted canine exposure using a surgical template
EXPERIMENTALPalatally impacted canine exposure using the conventional free-hand method
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semmelweis University Department of Community Dentistry
Budapest, Budapest, 1088, Hungary
Related Publications (1)
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.
PMID: 38906453DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- senior lecturer
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 18, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share