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

NCT03696498 | Active Not Recruiting DMC

• 1 other identifier: THE PAPRICA TRIAL
• Study Type: interventional
• Target: 177
• Locations: 4 countries
• Sites: 11

Brief 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

Keywords

Partial excavation; Deep dentin caries; RCT

Outcome Measures

Primary Outcomes (2)

• Pulp complications

  Pulp complications will be assessed using a registration scheme: no pulp vitality, based on negative thermal and/or electric pulp test; apical radiolucency as assessed by the blinded examiner based on radiograph; pulp exposure due to treatment of signs of pulpitis; endodontic treatment (root filling).

  3 years

• Restoration quality

  Quality of restorations will be assessed using af registration scheme: intact restoration: Intact restoration, Total lost of restoration; Partly Lost of restoration

  3 years

Study Arms (2)

Partial caries excavation (1 step)

EXPERIMENTAL

Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Local anaesthesia shall be used. as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine. Intervention: A permanent resin restoration is placed on top of the remained caries.

Procedure: Resin restoration (1 step)

Partial caries excavation (2 steps)

ACTIVE COMPARATOR

Patients with radiographical caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine is candidates for the treatment. Before randomisation, the participants receive the first excavation procedure as this procedure is identical for the two interventions tested in this trial. A partial removal of carious dentine is performed with superficial removal of the outermost infected and necrotic part of the demineralised dentine. Intervention: After randomisation, 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 temporary restoration is removed, final excavation is carried out with hand excavators until firm but stained dentine remains, and a permanent resin restoration is placed.

Procedure: Resin restoration (2 steps)

Interventions

Resin restoration (1 step) PROCEDURE

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

Partial caries excavation (1 step)

Resin restoration (2 steps) PROCEDURE

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.

Partial caries excavation (2 steps)

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults and children \>9 years.
• Primary coronal caries without pain in a permanent tooth (pain is accepted when evoked by a hot, cold, or sweet stimulus of short duration and disappears when the stimulus is removed).
• The radiograph shows caries within the pulpal ¼ of the dentine with the presence of a radiodense zone separating the pulp from the demineralised dentine.
• No exposure of the pulp following the first excavation.
• Available for recall at 1 and 3 years.
• Written informed consent.

You may not qualify if:

• Actual deep carious tooth presenting spontaneous and/or prolonged pain within the last 6 months, or pain causing disturbed night sleep.
• Actual deep carious tooth with negative thermal and/or electrical pulp test.
• Radiograph shows apical or radicular radiolucency of the tooth.
• Deep carious tooth has restoration in close contact with pulp.
• No written informed consent.

Sponsors & Collaborators

• University of Copenhagen: lead
• Public Dental Health Care System, Denmark: collaborator
• Malmö University, Sweden: collaborator
• Halmstad County Hospital: collaborator
• Karolinska Institutet: collaborator
• Göteborg University: collaborator
• Lithuania: collaborator

Study Sites (11)

PDHS - Bornholm

Rønne, Bornholm, 3700, Denmark

Location

PDHS - Gentofte

Gentofte Municipality, Charlottenlund, 2920, Denmark

Location

University of Copenhagen

Copenhagen, Copenhagen N, 2200, Denmark

Location

PDHS - Copenhagen municipality

Copenhagen, Copenhagen V, 1662, Denmark

Location

PDHS - Randers municipality

Randers, Randers C, 8900, Denmark

Location

PDHS - Hørsholm

Hørsholm, Rungsted Kyst, 2960, Denmark

Location

PDHS - Aarhus municipality

Aarhus, Viby J, 8260, Denmark

Location

PDHS - Brøndby

Brøndby, 2605, Denmark

Location

University of Norway - Lithuania

Klaipėda, Lithuania

Location

Preventive Dentistry Department

Moscow, Dolgorukovskaya, Russia

Location

Malmo University

Malmo, Malmo C, 20506, Sweden

Location

Study Officials

• Lars Bjørndal, Dr odont, PhD

  University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, PhD, dr odont

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: October 4, 2018
• Study Start: January 1, 2015
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (8); RU (1); LI (1); SE (1)