Effect of Topacal C-5 on Enamel Remineralisation in Situ

ISRCTN	ISRCTN36415433
DOI	https://doi.org/10.1186/ISRCTN36415433
Protocol serial number	N0436130443
Sponsor	Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr B Alshammari
Scientific

Department of Child Dental Health
Leeds Dental Institute
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom

Phone	+44 (0)113 233 6138
Email	r&d@leedsth.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effect of Topacal C-5 on Enamel Remineralisation in Situ
Study objectives	The aim of this study is to study the effect of Topacal C-5 which is milk protein based and fluoride free and its role in enamel remineralisation
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oral Health: Dental materials
Intervention	Randomised controlled trial: Topacal C-5 or distilled water
Intervention type	Other
Primary outcome measure(s)	Remineralisation of enamel slabs as determined using transverse microradiography and microhardness testing.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/10/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Key inclusion criteria	Healthy adults aged 18-65 years residing in Leeds
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/2003
Date of final enrolment	31/10/2003

Department of Child Dental Health

Leeds
LS2 9LU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

24/05/2016: No publications found, study status unverified