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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
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
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

Study type
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

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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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
QLD 4000
Country [1] 237311 0
Funding source category [2] 237312 0
Name [2] 237312 0
Australian Dental Research Foundation
Address [2] 237312 0
The Hon. Secretary
Australian Dental Research Foundation Inc.
PO Box 520
Country [2] 237312 0
Funding source category [3] 237313 0
Commercial sector/Industry
Name [3] 237313 0
Address [3] 237313 0
11-21 Gilby Road
Mt. Waverley VIC 3149
Country [3] 237313 0
Primary sponsor type
Dr Sonali Mistry
Specialist Paediatric Dentist
Kingston Oral Health Centre
PO Box 210
QLD 4114
Secondary sponsor category [1] 236796 0
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
Secondary sponsor category [2] 236797 0
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
QLD 4114
Country [2] 236797 0
Secondary sponsor category [3] 236798 0
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
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
QLD 4114
Country [1] 758 0
Other collaborator category [2] 759 0
Name [2] 759 0
University of Queensland
Address [2] 759 0
School of Dentistry
200 Turbot Street
Brisbane, Qld 4000
Country [2] 759 0

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
Approval date [1] 239557 0
Ethics approval number [1] 239557 0

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
Trial related presentations / publications
Public notes

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
QLD 4114
Country 13134 0
Phone 13134 0
+61 7 3412 7200
Fax 13134 0
Email 13134 0
Contact person for scientific queries
Name 4062 0
Dr Sonali Mistry
Address 4062 0
Kingston Oral Health Centre
PO Box 210
QLD 4114
Country 4062 0
Phone 4062 0
+61 7 3412 7200
Fax 4062 0
Email 4062 0

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