Clinical Trial: Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth

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 Summary:

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:

Pat
Sponsor: University of Tromso

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Pain and discomfort after tooth extraction reported by questionnaire [ Time Frame: 1 week after tooth extraction ]

Patients pain and discomfort will be reported by VAS - scale


Original Secondary Outcome: Same as current

Information By: University of Tromso

Dates:
Date Received: January 28, 2016
Date Started: September 2014
Date Completion: June 2018
Last Updated: February 2, 2016
Last Verified: February 2016