Condition category
Oral Health
Date applied
30/08/2005
Date assigned
12/10/2005
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Day

ORCID ID

Contact details

Department of Paediatric Dentistry
Level 6
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
+44 (0)113 343 6138/9
p.f.day@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 2, 9-12-04

Study information

Scientific title

Acronym

Study hypothesis

This is a multi-centre randomised controlled trial to compare the effectiveness of Ledermix® and Ultracal XS® on the type of healing (favourable or unfavourable) following tooth avulsion and replantation.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tooth avulsion and replantation

Intervention

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).

Intervention type

Drug

Phase

Not Specified

Drug names

Ledermix®, Ultracal XS®

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

20/07/2005

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Not fulfilling the inclusion criteria

Recruitment start date

20/07/2005

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatric Dentistry
Leeds
LS2 9LU
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Senior Research Manager
School of Medicine
24 Hyde Terrace
University of Leeds
Leeds
LS2 9LN
United Kingdom
+44 (0)113 343 3264
j.gower@leeds.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Blackwell Supplies (purchase of equipment and free materials)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Optident (free materials)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medartis (free materials)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21763893

Publication citations

  1. Results

    Day PF, Duggal MS, High AS, Robertson A, Gregg TA, Ashley PF, Welbury RR, Cole BO, Westland S, Discoloration of teeth after avulsion and replantation: results from a multicenter randomized controlled trial., J Endod, 2011, 37, 8, 1052-1057, doi: 10.1016/j.joen.2011.04.014.

Additional files

Editorial Notes