Effects of Partical Excavation in One Versus Two Procedures of Primary Deep Caries (PAPRICA)

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.

Conditions

• Primary Dental Caries

Interventions

PROCEDURE

Resin restoration (1 step)

Permanent resin restoration is placed on top of the partial removed caries.

PROCEDURE

Resin restoration (2 steps)

A calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months the patients are recalled. The temporary restoration is removed and final excavation is carried out with hand excavators until firm but stained dentine remains. A permanent resin restoration is performed.

Sponsors & Collaborators

• Public Dental Health Care System, Denmark

  collaborator OTHER

• Malmö University, Sweden

  collaborator UNKNOWN

• Halmstad County Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Lithuania

  collaborator UNKNOWN

• University of Copenhagen

  lead OTHER

Principal Investigators

• Lars Bjørndal, Dr odont, PhD · University of Copenhagen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

9 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2024-08-31

Completion

2024-12-31

Countries

• Denmark
• Lithuania
• Russia
• Sweden

Study Locations