View - CTU

2008). Another recent Cochrane review investigated the pulp management for caries
in adults (Miyashita et al. 2007). Four trials were found suitable for inclusion, but
again no definitive indication as to the most effective method of pulp treatment of
carious teeth was found, and the review authors concluded that further well-designed
trials are needed. Randomized trials are internationally considered the gold standard
for comparing interventions (Gluud & S0rensen 1995, Chalmers 2001, Gluud 2006a)
and at the top of the hierarchy of evidence (Sackett et al. 2000, Gluud 2006a, Gluud
2006b). Dental research in general is progressing towards adopting adequate trials,
reducing the risk of systematic errors ('bias') and the risk of random errors ('play of
chance') (Sjogren & Halling 2001 ), and utilising systematic reviews of such trials
(Bader & Ismail, 2004 ). The strategy for managing deep caries and pulp inflammation
has been expressed differently through the years (Bj0rndal 2008). The variation may
be related to: (i) lack of non-invasive devices that could measure the status of the
pulp, (ii) the tradition of not defining the depth and progression rate of the caries
lesion, (iii) the lack of randomized clinical trials investigating the outcome of deep
caries excavation. It has been suggested (Miyashita et al. 2007) that a decision must
be made as to whether all carious tooth tissue should be removed, and this warrants
a clinical trial in itself. Another category of clinical trials should relate to the
management of the exposed pulp.
Hypothesis Illa:
One direct complete excavation procedure is as good as a less invasive stepwise
excavation approach to prevent root canal treatment.
Aim Illa:
To carry out a randomized clinical trial comparing stepwise excavation versus direct
complete excavation on deep caries in adults, using pulp exposure, 1-year pulp
vitality without apical radiolucency, and pain as the outcome measures.
Hypothesis I/lb:
Treatment of pulp exposures with direct pulp-capping is as good as partial pulpotomy
in terms of pulp survival.
Aim /fib:
To carry o
pulpotomy
apical radii
Context:
Danish N
Remuner
Fig. 5. In St
Trial desi£
Definitions
The numbe
sample siz,
detect a
excavation
error of 10'
pulp vitalit)
patients, ta
Consecutiv
participatec
the enrolm
numbers o·
trial would
Inclusion a
16