Pulp therapy for management of deep caries in primary molar teeth

Children undergoing pulp therapy for deep caries with different technique and agents and their success rates

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000658213

Enrollment

600

Registered

2009-08-04

Start date

2009-09-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

2 Years to 8 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy children attending Logan-Beaudesert Area Oral Health Program for routine dental treatment, and requiring management of deep caries.

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

Outcome results