Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58467151
Enrollment
200
Registered
2005-10-12
Start date
2005-07-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth avulsion and replantation Oral Health Tooth avulsion and replantation

Interventions

Pulp extirpation as early as possible (Day 0?10) following tooth avulsion and placement of Ledermix® versus pulp extirpation at Day 7?10 and placement of Ultracal XS® (non setting calcium hydroxide).

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Not fulfilling the inclusion criteria

Design outcomes

Primary

MeasureTime frame
To compare the effect of these two root canal pastes on the periodontal healing and consequent tooth survival.

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026