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1agement for caries
ie for inclusion, but
>f pulp treatment of
irther well-designed
d the gold standard
2001, Gluud 2006a)
31uud 2006a, Gluud
:ing adequate trials,
fom errors ('play of
1iews of such trials
d pulp inflammation
1. The variation may
re the status of the
1 rate of the caries
e outcome of deep
hat a decision must
::1, and this warrants
1ould relate to the
s invasive stepwise
vation versus direct
>osure, 1-year pulp
:ures.
~s partial pulpotomy
Aim /fib:
To carry out a randomized clinical trial comparing direct pulp-capping versus partial
pulpotomy of pulps exposed as a result of caries, using 1-year pulp vitality without
apical radiolucency, and pain, as the outcome measures.
Context:
Danish National Health Insurance
Remuneration system
Fig. 5. In Study Ill an endodontic preventive strategy is investigated.
Trial designs (Study Ill)
Study Ill
An endodontic
preventing strategy -
randomized clinical
trials investigating deep
caries excavation
Definitions of patients to be enrolled in the two randomized clinical trials
The number of patients needed to explore the hypothesis was found on the basis of a
sample size calculation (excavation trial): 134 patients were needed in each group to
detect a 20% difference between stepwise excavation and direct complete
excavation at a two-sided alpha level of 5% (type I error) and 90% power (type II
error of 10% ), when expecting 50% in the direct complete excavation group to retain .
pulp vitality without apical radiolucency after 1 year. The study needed at least 308
patients, taking a possible patient drop-out rate of 15% into account (134 x 2 x 1.15).
Consecutive patients referred to two Danish centres and four Swedish centres
participated. Sample size calculation was performed for the excavation trial only, as
the enrolment of patients to the pulp capping trial would be restricted to the actual
numbers of exposed pulps in the excavation trial. In this light the results of the pulp
trial would be difficult to assess and this trial should be considered a 'pilot trial'.
Inclusion and exclusion criteria were well-defined in both trials (Study Ill).
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