Tooth Eruption,Ectopic Clinical Trial
Official title:
Interceptive Study of Ectopic Eruption of Permanent Maxillary Canine Teeth
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.
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.
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