The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000658213
Ethics application status
Not yet submitted
Date submitted
10/07/2009
Date registered
4/08/2009
Date last updated
4/08/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Pulp therapy for management of deep caries in primary molar teeth
Scientific title
Children undergoing pulp therapy for deep caries with different technique and agents and their success rates
Secondary ID [1] 921 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Management of deep caries in children 237218 0
Condition category
Condition code
Oral and Gastrointestinal 237536 237536 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Invasive pulp therapy, or pulpotomy is a standard dental procedure carried out to remove infected/ and or inflammed dental pulp, followed by a pulp agent that is placed over the remaining healthy pulp.

Indirect Pulp Therapy (IPT) is carried out for teeth with no pulp exposure, and the base of the cavity is lined with an agent.

This procedure can take approximately half an hour, depending on child co-operation.

There are two pulp agents that will be evaluated against the control.
1- MTA (Mineral Trioxide Aggregate) which is a repair/ regeneration agent
2- Ledermix which is a mixture of antibiotic and steroid.

Treatment options are:
1) Pulpotomy with MTA, in which MTA is placed on the pulp after pulpotomy
2) Pulpotomy with Ledermix, in which Ledermix is placed on the pulp after pulpotomy
3) IPT (Indirect Pulp therapy) with MTA
4) IPT with Ledermix
Intervention code [1] 236914 0
Treatment: Other
Comparator / control treatment
“Standard Treatment”
Formocresol will be used for pulpotomy, with formocresol being used as the pulp agent as described above.

Glass ionomer cement will be used as the control for IPT. As mentioned above, it will be the agent lining the base of the tooth cavity with non-exposed pulps.

Treatment time is as described above, approximately half an hour.
Control group
Active

Outcomes
Primary outcome [1] 238346 0
Success rates of the pulp therapy.

This will be assessed by clinical and radiographic assessment where the absence of signs of infection and/or inflammation will be looked for. These include pain, redness, swelling, abscess, non-physiologic mobility and pathologic radiolucency on radiographs.

Moreover, a subjective interrogation to the parent or guardian of the child will be carried out to determine any signs and/or symptoms experienced by the patient.

Moreover, any other signs and symptoms that may not be accounted for, and are experienced by the child due to pulp therapy will also be noted.
Timepoint [1] 238346 0
2 years from intervention
Secondary outcome [1] 244763 0
Signs and Symptoms

For example, signs of infection and/or inflammation such as pain, redness, swelling, abscess and non-physiologic mobility
Timepoint [1] 244763 0
When the patient experiences symptoms or signs of concerns in the 2 year period following intervention.
Secondary outcome [2] 244764 0
Clinical and radiographic assessment
Timepoint [2] 244764 0
At baseline, 3 months and every 6 months after intervention for 2 years.

Eligibility
Key inclusion criteria
Healthy children attending Logan-Beaudesert Area Oral Health Program for routine dental treatment, and requiring management of deep caries.
Minimum age
2 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All subjects recruited in the study will be systemically healthy although they may have decayed teeth.

So the key exclusion criteria is: Unhealthy children, for example, children with chronic illness such as cancer, and children outside the age range of 2-8years

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.

Subjects requiring management of deep caries will be randomly allocated to a pulp agent using sequence method of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To establish a sequence, random draw technique will be used where the agent options are written on a piece of paper and an option drawn.

If more than one tooth requires management, the second tooth will have another draw and if there is a third tooth, it will get the last agent. If there are four teeth, the process will start all over again.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237311 0
Government body
Name [1] 237311 0
Dental Board of Queensland
Address [1] 237311 0
Office of Health Practitioner Registration Boards
Level 8, Forestry House
160 Mary Street
Brisbane
QLD 4000
Country [1] 237311 0
Australia
Funding source category [2] 237312 0
Charities/Societies/Foundations
Name [2] 237312 0
Australian Dental Research Foundation
Address [2] 237312 0
The Hon. Secretary
Australian Dental Research Foundation Inc.
PO Box 520
ST LEONARDS NSW 1590
Country [2] 237312 0
Australia
Funding source category [3] 237313 0
Commercial sector/Industry
Name [3] 237313 0
Dentsply
Address [3] 237313 0
11-21 Gilby Road
Mt. Waverley VIC 3149
Country [3] 237313 0
Australia
Primary sponsor type
Individual
Name
Dr Sonali Mistry
Address
Specialist Paediatric Dentist
Kingston Oral Health Centre
PO Box 210
Woodridge
QLD 4114
Country
Australia
Secondary sponsor category [1] 236796 0
Individual
Name [1] 236796 0
A/Prof Wan Kim Seow
Address [1] 236796 0
Associate Professor, Paediatric Dentistry
School of Dentistry
200 Turbot Street
Brisbane, Qld 4000
Country [1] 236796 0
Australia
Secondary sponsor category [2] 236797 0
Individual
Name [2] 236797 0
Dr Trevor Holcombe
Address [2] 236797 0
Director- Oral Health, Logan-Beaudesert Area, Metro South Health Service District
Kingston Oral Health Centre
PO Box 210
Woodridge
QLD 4114
Country [2] 236797 0
Australia
Secondary sponsor category [3] 236798 0
Individual
Name [3] 236798 0
Prof. Laurie Walsh
Address [3] 236798 0
Head of School
School of Dentistry
200 Turbot Street
Brisbane, Qld 4000
Country [3] 236798 0
Australia
Other collaborator category [1] 758 0
Government body
Name [1] 758 0
Oral Health Program, Logan-Beaudesert Area, Metro South Health Service District, Queensland Health
Address [1] 758 0
Kingston Oral Health Centre
PO Box 210
Woodridge
QLD 4114
Country [1] 758 0
Australia
Other collaborator category [2] 759 0
University
Name [2] 759 0
University of Queensland
Address [2] 759 0
School of Dentistry
200 Turbot Street
Brisbane, Qld 4000
Country [2] 759 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239557 0
Ethics committee address [1] 239557 0
Ethics committee country [1] 239557 0
Date submitted for ethics approval [1] 239557 0
13/08/2009
Approval date [1] 239557 0
Ethics approval number [1] 239557 0

Summary
Brief summary
The purpose of the study is to evaluate pulp agents and techniques used for management of deep decay in children's primary molar teeth. Previous investigations suggest that there should be no difference in outcomes among various techniques, provided that proper diagnosis and good coronal seal are achieved. However, differences in chemicals may lead to different pulp responses. The study will determine which materials are most suitable.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 29887 0
Address 29887 0
Country 29887 0
Phone 29887 0
Fax 29887 0
Email 29887 0
Contact person for public queries
Name 13134 0
Dr Sonali Mistry
Address 13134 0
Kingston Oral Health Centre
PO Box 210
Woodridge
QLD 4114
Country 13134 0
Australia
Phone 13134 0
+61 7 3412 7200
Fax 13134 0
Email 13134 0
s.mistry@uq.edu.au
Contact person for scientific queries
Name 4062 0
Dr Sonali Mistry
Address 4062 0
Kingston Oral Health Centre
PO Box 210
Woodridge
QLD 4114
Country 4062 0
Australia
Phone 4062 0
+61 7 3412 7200
Fax 4062 0
Email 4062 0
s.mistry@uq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results