NCT02675036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

4.8 years

First QC Date

January 28, 2016

Last Update Submit

October 30, 2018

Conditions

Tooth Eruption,Ectopic

Keywords

ectopiccanine teeth, impacted teeth, tooth eruption, orthodontics

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (1)

  • Pain and discomfort after tooth extraction reported by questionnaire

    1 week after tooth extraction

Other Outcomes (1)

  • Full eruption of permanent ectopic canine tooth in to the oral cavity

    12-30 months after primary canine tooth extraction

Study Arms (2)

Primary canine tooth

EXPERIMENTAL

Extraction of primary canine tooth

Procedure: Tooth extraction

Primary canine and primary molar teeth

EXPERIMENTAL

Extraction of primary canine and primary first molar teeth

Procedure: Tooth extraction

Interventions

Tooth extractionPROCEDURE
Primary canine and primary molar teethPrimary canine tooth

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tannhelsetjenestens kompetansesenter for Nord-Norge

Tromsø, 9019, Norway

Location

Related Publications (2)

  • 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.

    PMID: 34967448DERIVED

  • 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.

    PMID: 33378508DERIVED

MeSH Terms

Conditions

Tooth Eruption, EctopicTooth, ImpactedExanthema

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeDentistry

Study Officials

  • Heidi Kerosuo, PhD

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 5, 2016

Study Start

September 1, 2014

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)