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
| ISRCTN | ISRCTN58467151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58467151 |
| Secondary identifying numbers | Version 2, 9-12-04 |
- Submission date
- 30/08/2005
- Registration date
- 12/10/2005
- Last edited
- 21/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Day
Scientific
Scientific
Department of Paediatric Dentistry
Level 6
Leeds Dental Institute
Clarendon Way
Leeds
LS2 9LU
United Kingdom
| Phone | +44 (0)113 343 6138/9 |
|---|---|
| p.f.day@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Tooth avulsion and replantation |
| Intervention | Pulp extirpation as early as possible (Day 010) following tooth avulsion and placement of Ledermix® versus pulp extirpation at Day 710 and placement of Ultracal XS® (non setting calcium hydroxide). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ledermix®, Ultracal XS® |
| Primary outcome measure | 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 study start date | 20/07/2005 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key exclusion criteria | Not fulfilling the inclusion criteria |
| Date of first enrolment | 20/07/2005 |
| Date of final enrolment | 30/09/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Paediatric Dentistry
Leeds
LS2 9LU
United Kingdom
LS2 9LU
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Senior Research Manager
School of Medicine
24 Hyde Terrace
University of Leeds
Leeds
LS2 9LN
England
United Kingdom
| Phone | +44 (0)113 343 3264 |
|---|---|
| j.gower@leeds.ac.uk | |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Industry
Blackwell Supplies (purchase of equipment and free materials)
No information available
Optident (free materials)
No information available
Medartis (free materials)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No |
