Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03696498 |
| Other study ID # |
THE PAPRICA TRIAL |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2015 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
February 2024 |
| Source |
University of Copenhagen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Deep caries is the most frequent reason for performing root canal treatments.
Minimally invasive methods for the treatment of deep carious lesions might therefore be
relevant to avoid pulp exposures and consequently to prevent root canal treatments. A 2 step
carious removal approach has shown to avoid exposures. But we do not know whether a selective
removal of carious tissue in well-defined deep caries lesions involving the pulpal quarter of
the dentin can be successfully completed in 1 step.
Objectives: To investigate partial (selective) excavation by 1 vs 2 step in the treatment of
deep caries in permanent teeth.
Design: RCT multinational superiority study with 2 parallel groups and blinded outcome
assessment. The allocation sequence for partial (selective) carious removal vs 2 step
stepwise carious removal (1:1) will be centralized and computer-generated, stratified for age
and centre and concealed for the investigators.
Inclusion criteria: children (≥9 years) and adults with primary well-defined deep caries in a
permanent tooth. The lesion should reach the pulpal ¼ of the dentin with presence of a
radiodense zone on a bitewing.
Exclusion criteria: spontaneous and prolonged pain within the last 6 months; pain causing
disturbed night sleep; negative pulp test; apical radiolucency; restoration in close contact
with pulp; the patient has communication problems; no written informed consent.
Experimental intervention: 1-step selective carious removal to soft or firm dentine at
central site , and peripheral non selective carious removal to hard dentin followed by a
permanent resin restoration. Control intervention: Stepwise excavation (2- step, involving
first step which is identical to the experimental intervention but a base material and a
temporary glass-ionomer restoration is placed. The amount removed is as much as a proper
restoration can be placed. After 4-6 months the patients are recalled and the temporary
restoration is removed and final selective carious removal is completed until firm dentin
remains followed by permanent resin restoration.
The primary outcome is to avoid pulp complication at the 1-year follow-up evaluating. The
secondary outcomes are to arrest caries progression and sufficient restoration at the 1-year
follow-up. All outcomes will further be assessed 3 years after inclusion.
Description:
Originality of the project: The originality of the PAPRICA project will be to provide
high-quality clinical evidence for optimal treatment of deep caries lesions which is urgently
needed. The project is very relevant within an area that has been known for suggestions of
many treatments with the most invasive ones being the most popular ones. Only few previous
studies define the depth of the carious lesion, data on well-defined lesions will clarify
guidelines. Also, our design of this trial will attempt to reduce the risk of bias which is
always critical when the investigator can't be blinded. In this respect the randomization
will first be initiated after the 1 step of carious removal is completed. Results from a
systematic review and a recent meta-analysis support stepwise excavation compared to complete
excavation. However, firm evidence for one visit selective caries removal to soft dentine
(previously defined as partial excavation) is still lacking. The project will for the first
time investigate the caries treatment dilemma within a broader clinical context and thus
aiming to reduce number of dental visits and to reduce acute pain. In the PAPRICA project a
well-defined selective caries removal to soft dentine will be used as the lack of definitions
are frequent in previously published clinical trials.
With this study we are aiming to 1) improve the treatment of deep caries by markedly reducing
tooth-related pain, and consequently reduce the number of sick days due to toot-related pain;
2) reduce the number, complexity and duration of dental visits needed to treat deep caries;
3) provide data for an updated evidence-based treatment guideline for an improved health-care
system.
Selection of participants: All patients at a participating clinical trial site are considered
for participation. Patients will be eligible, if they comply with well-defined inclusion and
exclusion criteria.
Statistical plan and data analysis: Sample size is 668 patients, based on the primary outcome
'pulp complications' among controls being 25%, and 15% in the experimental group, and
combined with a type-I error of 5%; and a type-II error of 10%. Blinded interim analyses will
be carried out. Statistical analysis of data from outcome measures - the gained frequencies
of treatments leading to preservation of vital tooth without pain, apical pathology and no
root filling will be examined using logistic regression analysis to assess the treatment
effect adjusted for stratification variables. Odds ratio estimates will be used with 95% CI.
Missing data will be handled using multiple imputations.
Randomization: Only one deep caries lesion per patient will be randomized. The trial will use
block randomization with the following to stratifications variables: 1) Center; 2) Age (9-20
years/over 20 years). The randomization in the PAPRICA trial will be performed using an
online system.
Blinding: The investigator performing the follow-up examination is not the same who performed
the treatment. The analysis of the radiographs of the tooth at follow-up is carried out by an
observer-committee being blinded for the intervention. The statistical analyses are carried
out blinded. Patient blinding is not possible as the two intervention groups are performed as
either a one-treatment procedure or a two-treatment procedure.
The patients who will be randomly allocated to 1-step partial caries removal will receive a
treatment that normally is not practiced in relation to deep caries. However, there is a lack
of randomised clinical trials investigating, whether partial caries removal has a positive
prolonged effect with respect to maintained vital pulp and absence of apical pathology. The
possible gain with the proposed treatment concept could be that the treatment of deep caries
could be rationally performed without an extra treatment session and it may to a larger
extent lead to an avoidance of exposure to the pulp. Patients who will be randomly allocated
to 2-step partial caries removal receive a well-known treatment of deep caries. The intention
is that we will gain data to reduce the risk of pulp exposures and thus the number of root
canal treatments and possible reduce the number of days 'out-of' work due to tooth pain
following an unnecessary invasive treatment of deep caries
Discontinuation and withdrawal: If a patient does not show-up for an appointment, attempts to
make a re-appointment are carried out up to 3 times. It is important to stress that great
effort should be carried out in order to find reasons for not attending an established
appointment or if a patient wishes to withdraw from the trial. he investigators shall
discontinue a participant from the trial intervention at any time, if: 1) There are signs of
caries progression or failure of the restoration; 2) The participant is diagnosed with any of
the exclusion criteria during the intervention period (except 'deep carious tooth has
restoration in close contact with pulp'); 3) The participant experiences intolerable adverse
reactions.
