The effectiveness of an internet based computer database for data collection in a randomised controlled trial to evaluate immediate extirpation of necrotic pulp tissue and placement of Ledermix® in avulsed and replanted teeth in comparison to the current recommendations

Completed

• Conditions: Tooth avulsion and replantation; Oral Health

• Registration Number: ISRCTN58467151
• Lead Sponsor: niversity of Leeds (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

There are two ways to be accepted onto the trial; acute and delayed presentation to the specialist unit.

Inclusion criteria for acute presentation are:
1. Patients who have avulsed a tooth that has been replanted and are under the age of 16 years
2. The tooth has completed root development with or without an open apex (as these teeth have no chance of pulpal regeneration)
3. With no more than 20 minutes dry extra-alveolar time
4. 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
5. With no previous endodontic treatment carried out
6. 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)

Inclusion criteria for delayed presentation:
1. Where replantation has been carried out away from a specialist centre and is performed within the guidelines of the International Association of Dental Traumatology (2003)
2. 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.)
3. Meets the same inclusion criteria as listed above for acute presentation

Exclusion Criteria

Not fulfilling the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified