Dental Caries Clinical Trial
Official title:
The CAP-1 Trial: Effect of Stepwise Versus One Completed Excavation in Deep Caries in Permanent Teeth: A Randomised, Patient - and Observer-blinded Multicenter Trial
Brief summary
Background:
A large proportion of dental practice involves the treatment of caries in the permanent
dentition. In USA alone tooth related pain is annually responsible for 15 billions days lost
through sickness. We do not know whether a stepwise excavation is better or worse compared
with one final completed excavation in adults with deep caries with or without pain. A deep
carious lesion is in the risk zone of being pulpal exposed during excavation.
Aim:
The aim of the CAP-1-trial is to investigate the beneficial effects of stepwise excavation
during two visits versus óne completed excavation of deep caries in permanent teeth with or
without pain.
Patients:
Consecutive patients contacting the units involved in the CAP trial for the treatment of
deep caries. The trial will comprise 300 patients.
Design:
CAP-1-trial is a randomised patient- and observer-blinded multicenter trial, with two
parallel intervention groups. Patients that fulfill the inclusions criteria and none of the
exclusions criteria, will be centrally bloc-randomised in Copenhagen Trial Unit, Copenhagen
DK, and stratified by age and pain. Allocation ratio is 1:1.
Interventions and products:
Patients are allocated for stepwise excavation in two visits or final excavation in one
visit. The patients will not be informed about the result of the randomisation, i.e. the
type of intervention. Therefore, all patients will be contacted for two visits. The second
visit in the stepwise excavation group wil be used for the second and final excavation, and
for the performance of a permanent restoration. The second visit in the one step excavation
group will solely be used for the performance of a permanent restoration. The interventions
in both groups are completed following 8-10 weeks after the randomisation.
A temporary calcium hydroxide based material is used in both groups (Dycal®). The temporary
restoration material, glas-ionomer cement is used (Ketac Molar®) in between visits, and a
resin material is used for the final restoration(Herculite®).
References
BJERKÉN E, WENNBERG A, TRONSTAD L. Endodontisk akutbehandling. Tandläkartidningen.
1980;72:314-9.
BJØRNDAL L, REIT C. The annual frequency of root-fillings, tooth extractions and pulp
related procedures in Danish adults 1977-2003. Int Endod J 2004:37:782-788.
BJØRNDAL L. The deep caries lesion dilemma. In Nordic Dentistry 2004 yearbook (Schou L, ed).
Copenhagen, Denmark: Quintessence Publishing Co, Inc., 2004; 107-20.
BJØRNDAL L & THYLSTRUP A. A practice -based study on stepwise excavation of deep carious
lesions in permanent teeth: a 1-year follow-up study. Community Dent Oral Epidemiol
1998;26:122-8.
BJØRNDAL L. Treatment of deep carious lesions with stepwise excavation. A practice-based
study. Tandlaegebladet 1999;103:498-506.
BJØRNDAL L, LARSEN T, THYLSTRUP A. A clinical and microbiological study of deep carious
lesions during stepwise excavation using long treatment intervals. Caries Res 1997;31:411-.
BJØRNDAL L, LARSEN T. Changes in the cultivable flora in deep carious lesions following a
stepwise excavation procedure. Caries Res 2000;34:502-8.
BERGENHOLTZ G, SPÅNGBERG L. Controversies in endodontics. Crit Rev Oral Biol Med
2004;15:99-114.
FOUAD AF. Molecular mediators of pulpal inflammation. In Seltzer and Bender's Dental pulp (
Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002;
247-79.
KARLSSON P-O, REIT C. Reasons for endodontic treatment among Swedish general practitioners
(abstract). Int Endod J 1994;27:100.
KIRKEVANG L-L Periapical and endodontic status in Danish populations (Ph.D: thesis). Århus:
University of Aarhus; 2001.
LEKSELL E, RIDELL K, CVEK M, MEJÁRE I. Pulp exposure after stepwise versus direct complete
excavation of deep carious lesions in young posterior permanent teeth. Endod Dent Traumatol
1996;12:192-96.
MAGNUSSON B, SUNDELL SO. Stepwise excavation of deep carious lesions in primary molars. J
Int Ass Child 1977;8:36-40.
NADIN G, GOEL BR, YEUNG Ca, GLENNY AM. Pulp treatment for extensive decay in primary teeth
(Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester,Uk: John Wiley &
Sons, Ltd.
NÄRHI M. Dentinal and pulpal pain. In Textbook of Endodontology (Bergenholtz G,
Hørsted-Bindslev P, Reit C, eds). Oxford, UK: Blackwell Munksgaard, 2003; 43-56.
REIT C, HEDEN G, MILTHON R. Endodontiskt behandlingspanorama inom allmäntandvården.
Tandläkartidningen 1993;85:543-6.
RICKETTS DNJ, KIDD EAM, INNES N. Complete or ultraconservative removal of decayed tissue in
unfilled teeth (Protocol for a Cochrane Review). In: The Cochrane Libray, Issue 1, 2004.
Chichester , UK: John Wiley & Sons, Ltd.
SJÖSTRÖM O, SUNDBERG H. Arbetstidens fördelning på olika verksamheter i svensk tandvård
1988. Tandläkartidningen 1989;81:856-67.
SUDA H, IKEDA H. The circulation of the pulp. In Seltzer and Bender's Dental pulp
(Hargreaves KM, Goodis HE, eds). Chicago, USA: Quintessence Publishing Co, Inc., 2002;
123-50.
TAYLOR H, CURRAN NM. The Nuprin Pain Report. New York, Lou Harris, 1985.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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