ISRCTN ISRCTN34146674
DOI https://doi.org/10.1186/ISRCTN34146674
Protocol serial number N0013137376
Sponsor Department of Health
Funder Guy's and St. Thomas' NHS Foundation Trust (UK) - Own account & NHS R&D Support Funding
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
29/07/2013
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

Prof Thomas Pitt Ford
Scientific

Conservative Dentistry
F25 Guys Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom

Phone +44 (0)20 7188 1753
Email thomas.pitt-ford@kcl.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesInvestigation and evaluation of dental pulp response to new filling material.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOral Health
InterventionA randomised controlled trial comparing a new filling material to the standard filling material. The placement of fillings in teeth scheduled for extraction.
Intervention typeOther
Primary outcome measure(s)

Histological assessment of tissue response.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration36
Key inclusion criteria36 patients in total - therefore 18 patients in each of the two groups.
Key exclusion criteria1. Patients outside the age of 18-30 years
2. Pregnant women
Date of first enrolment01/08/2003
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Conservative Dentistry
London
SE1 9RT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2008 Yes No