Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth

Tooth Eruption,Ectopic Clinical Trial

Official title:

Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02675036
• Other study ID #: 2012/623/REK
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2014
• Est. completion date: June 2019

Study information

• Verified date: October 2018
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In addition the study will also measure pain and discomfort in relation to these two treatment alternatives.

Description:

Study objectives:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Exanthema
• Tooth Eruption,Ectopic

Intervention

Procedure:
• Tooth extraction

Locations

Country	Name	City	State
Norway	Tannhelsetjenestens kompetansesenter for Nord-Norge	Tromso

Sponsors (2)

Lead Sponsor	Collaborator
University of Tromso	University of Oulu

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Full eruption of permanent ectopic canine tooth in to the oral cavity	The ratio of fully erupted teeth in the oral cavity will be reported	12-30 months after primary canine tooth extraction
Primary	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	Pain and discomfort after tooth extraction reported by questionnaire	Patients pain and discomfort will be reported by VAS - scale	1 week after tooth extraction