Tooth Avulsion and Replantation
Conditions
Interventions
Trade Name: Ledermix
Pharmaceutical Form: Dental suspension
INN or Proposed INN: Demeclocycline Calcium (equivalent to Demeclocycline hydrochloride 30mg)
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria will be as follows; patients who have avulsed a tooth that has been replanted, being under the age of 16 years, the tooth has completed root development with or without an open apex (as these teeth have no chance of pulpal regeneration), with no more than 20 minutes dry extra-alveolar time, a maximum total time of one hour has elapsed with the tooth being kept outside the mouth in milk or other storage media and a maximum of 20 minutes being kept in dry conditions, with no previous endodontic treatment carried out, the patient presents to the specialist unit within ten days following the injury (this ensures that the patient has a chance of randomly being entered into one or other treatment group), and the replantation where carried out away from a specialist centre is performed within the guidelines of the International Association of Dental Traumatology (2003) and/or details can be obtained from the dentist who provided this treatment. (e.g. extra alveolar time, extra alveolar medium, dry time, surface contamination, antibiotics, etc). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If the patient fails to meet the inclusion criteria or refuses to sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect on periodontal healing and tooth survival of early pulp extirpation (root canal treatment) with Ledermix® (a steroid and antibiotic paste) compared to the current guidelines (International Association of Dental Traumatology) following permanent tooth avulsion (where the tooth is completely knocked out of the mouth) ;Secondary Objective: To evaluate the effectiveness of a web based computer database for data collection in a multi-centred randomised controlled trial for two types of treatment for avulsion injuries.; Primary end point(s): The defined success of the treatment is related to the healing of the periodontal ligament and therefore tooth survival. Where there is no ankylosis (e.g. periodontal healing) following the clinical and radiographic tests detailed above at 12 months periodontal healing will be assumed. | — |
Countries
United Kingdom
Outcome results
None listed