Tooth Eruption,EctopicNCT02675036
Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth
A study testing Tooth extraction in people with Tooth Eruption,Ectopic, run by University of Tromso at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Eruption,Ectopic
- What is being tested?
- Tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2014to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- previous orthodontic treatment
- any disease not allowing local anesthesia or extraction
- craniofacial syndromes, cleft lip palate
- odontomas, cysts
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Tooth Eruption,Ectopic
- Being tested
- Tooth extraction
- Keywords
- ectopiccanine teeth, impacted teeth, tooth eruption, orthodontics
- Medical subject headings
- Tooth Eruption, Ectopic, Tooth, Impacted, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extractionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Primary canine tooth | Experimental | Extraction of primary canine tooth Receives: Procedure: Tooth extraction |
| Primary canine and primary molar teeth | Experimental | Extraction of primary canine and primary first molar teeth Receives: Procedure: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Pain and discomfort after tooth extraction reported by questionnaire
Patients pain and discomfort will be reported by VAS - scale
Measured: 1 week after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tooth Eruption,EctopicStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Sponsor
- Investigators
- Heidi Kerosuo, PhD, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675036
- Sponsor's protocol ID
- 2012/623/REK
- Status last verified
- Oct 2018
- First submitted
- 28 Jan 2016
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34967448Hadler-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.
PubMed 33378508
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth
- ClinicalTrials.gov ID
- NCT02675036
- Acronym / sponsor ID
- 2012/623/REK
- Conditions
- Tooth Eruption,Ectopic
- Keywords
- ectopiccanine teeth, impacted teeth, tooth eruption, orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- Sep 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 Feb 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary canine tooth | Experimental | Procedure: Tooth extractionExtraction of primary canine tooth |
| Primary canine and primary molar teeth | Experimental | Procedure: Tooth extractionExtraction of primary canine and primary first molar teeth |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- previous orthodontic treatment
- any disease not allowing local anesthesia or extraction
- craniofacial syndromes, cleft lip palate
- odontomas, cysts
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 |
|---|---|---|
| Tooth extraction | Procedure or surgery | Primary canine and primary molar teeth, Primary canine tooth |
Primary outcome
Change in permant canine tooth position measured by Sector and Alpha angle
Time frame: 12 months
Change in Sector and Alpha angle measured on panoramic radiographs will be reported
1 secondary outcome
Pain and discomfort after tooth extraction reported by questionnaire
Time frame: 1 week after tooth extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Derived from this study: PubMed 34967448Benson 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.
- Derived from this study: PubMed 33378508Hadler-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.
- Individual participant dataSharing planned: No
Related trials for Tooth Eruption,Ectopic
Recruiting
The Effectiveness of Early Intervention to Correct the Position of PDC:s
Ectopic Tooth Eruption, Palatal Expansion Technique
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.
Heidi Kerosuo, PhD principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction in people with Tooth Eruption,Ectopic, run by University of Tromso at 1 site in Norway.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2018. 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 Norway. 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?
Results are not available in the source record.
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?
Change in permant canine tooth position measured by Sector and Alpha angle (time frame: 12 months). 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 NCT02675036, which also lists 2 linked publications.
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 1 Nov 2018.