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Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth

Primary Purpose

Tooth Eruption,Ectopic

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tooth extraction
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Eruption,Ectopic focused on measuring ectopiccanine teeth, impacted teeth, tooth eruption, orthodontics

Eligibility Criteria

9 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • mixed dentition with both primary maxillary canine and primary maxillary first molars present
  • palatally ectopic canines present. (palatally ectopic canines will be diagnosed via measurements developed by Ericson and Kurol using DPT images. A canine with and alpha angle of ≥ 25 degrees in sectors 2 through 5, and palatal position observed on intraoral radiographs

Exclusion Criteria:

  • previous orthodontic treatment
  • any disease not allowing local anesthesia or extraction
  • craniofacial syndromes, cleft lip palate
  • odontomas, cysts

Sites / Locations

  • Tannhelsetjenestens kompetansesenter for Nord-Norge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary canine tooth

Primary canine and primary molar teeth

Arm Description

Extraction of primary canine tooth

Extraction of primary canine and primary first molar teeth

Outcomes

Primary Outcome Measures

Change in permant canine tooth position measured by Sector and Alpha angle
Change in Sector and Alpha angle measured on panoramic radiographs will be reported

Secondary Outcome Measures

Pain and discomfort after tooth extraction reported by questionnaire
Patients pain and discomfort will be reported by VAS - scale

Full Information

First Posted
January 28, 2016
Last Updated
October 30, 2018
Sponsor
University of Tromso
Collaborators
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT02675036
Brief Title
Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth
Official Title
Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso
Collaborators
University of Oulu

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see whether extraction of the primary canine tooth or extraction of both the primary canine - and the primary first molar tooth is most effective in the treatment of palatally ectopic canine teeth in the maxilla. In addition the study will also measure pain and discomfort in relation to these two treatment alternatives.
Detailed Description
Study objectives: Evaluate the effectiveness of concomitant extraction of the maxillary deciduous canine and maxillary deciduous first molar as compared to extraction of the deciduous maxillary canine only as an interceptive measure for improving the eruption path of ectopic maxillary canines. Evaluate whether there is a difference in the use of analgesics, pain and discomfort between the two treatment groups in 1. Procedure: After informed consent patients will randomly be assigned to one of two groups. Group1: Extraction of the deciduous canine only Group 2: Extraction of both the deciduous canine and the deciduous first molar Randomization The block randomization method will be used. Block sizes will randomly vary from 2, 4, 6 and 8. Blocks will be generated from free software at http://www.randomization.com . Allocation concealment is done by enclosing assignments into sequentially numbered envelopes. Envelopes that will have to be torn to open will be used. The randomization process will be done by a staff member at TkNN that is not involved in the trial. Prior to extractions topical anesthetics will be given for two minutes, before the buccal and palatal infiltration of local anesthetic (1,8 ml dose, 20mg/ml lidocain with 12,5 g/ml epinephrine). Patients and parents will be given oral postoperative information, including a recommendation to use non-prescription analgesics at their own discretion. Clinical and Radiographic controls and evaluation: Patients will be controlled clinically and radiographically (DPT) after 6 and 12 months. If improvement is not detectable after 12 months, alternative treatment will be suggested (surgical exposure, fixed orthodontic appliances, extractions). All cases which do not need alternative approaches will be followed until the tooth is erupted in the mouth. Sector, alpha angle and d-distance will be measured on DPT-images Dental anxiety Before any extractions are performed each patient will answer the modified dental anxiety scale (MDAS). Pain and discomfort When the patients have performed their extractions they will receive two questionnaires, regarding pain and discomfort and use of analgesics, to fulfill at home and return by mail. The first part shall be answered the first evening as the extraction was performed and the second part should be answered one week post extraction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Eruption,Ectopic
Keywords
ectopiccanine teeth, impacted teeth, tooth eruption, orthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary canine tooth
Arm Type
Experimental
Arm Description
Extraction of primary canine tooth
Arm Title
Primary canine and primary molar teeth
Arm Type
Experimental
Arm Description
Extraction of primary canine and primary first molar teeth
Intervention Type
Procedure
Intervention Name(s)
Tooth extraction
Primary Outcome Measure Information:
Title
Change in permant canine tooth position measured by Sector and Alpha angle
Description
Change in Sector and Alpha angle measured on panoramic radiographs will be reported
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain and discomfort after tooth extraction reported by questionnaire
Description
Patients pain and discomfort will be reported by VAS - scale
Time Frame
1 week after tooth extraction
Other Pre-specified Outcome Measures:
Title
Full eruption of permanent ectopic canine tooth in to the oral cavity
Description
The ratio of fully erupted teeth in the oral cavity will be reported
Time Frame
12-30 months after primary canine tooth extraction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: mixed dentition with both primary maxillary canine and primary maxillary first molars present palatally ectopic canines present. (palatally ectopic canines will be diagnosed via measurements developed by Ericson and Kurol using DPT images. A canine with and alpha angle of ≥ 25 degrees in sectors 2 through 5, and palatal position observed on intraoral radiographs Exclusion Criteria: previous orthodontic treatment any disease not allowing local anesthesia or extraction craniofacial syndromes, cleft lip palate odontomas, cysts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Kerosuo, PhD
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tannhelsetjenestens kompetansesenter for Nord-Norge
City
Tromso
ZIP/Postal Code
9019
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34967448
Citation
Benson PE, Atwal A, Bazargani F, Parkin N, Thind B. Interventions for promoting the eruption of palatally displaced permanent canine teeth, without the need for surgical exposure, in children aged 9 to 14 years. Cochrane Database Syst Rev. 2021 Dec 30;12(12):CD012851. doi: 10.1002/14651858.CD012851.pub2.
Results Reference
derived
PubMed Identifier
33378508
Citation
Hadler-Olsen S, Sjogren A, Steinnes J, Dubland M, Bolstad NL, Pirttiniemi P, Kerosuo H, Lahdesmaki R. Double vs single primary tooth extraction in interceptive treatment of palatally displaced canines. Angle Orthod. 2020 Nov 1;90(6):751-757. doi: 10.2319/031920-196.1.
Results Reference
derived

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Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth

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