DENTAL TRAUMA: The effectiveness of an internet based computer database for data collection in a randomised controlled trail to evaluate immediate extirpation of necrotic pulp tissue and placement of Ledermix in avulsed and replanted teeth in comparison to the current recommendations.
- Conditions
- Tooth Avulsion and Replantation
- Registration Number
- EUCTR2004-005188-12-GB
- Lead Sponsor
- niversity of Leeds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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
If the patient fails to meet the inclusion criteria or refuses to sign the consent form.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method