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Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis

NCT04672070 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-07-14

No results posted yet for this study

Summary

The study design is a randomized controlled trial and up to 120 teeth, 50 in each of the 2 groups, will be enrolled from the patients at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit.

The primary aim of this study is to compare the efficacy of selective caries removal (SCR) and pulpotomy in preventing pulp necrosis and apical periodontitis in teeth with deep dental caries radiographically extending at least 2/3 into the width of dentine, over a review period of 6 months, 1, 3, and 5 years. The secondary aim of this study is to compare the costs (tangible i.e. restorative treatment costs, and intangible i.e. number of treatment visits and time spent at clinic to complete treatment) and tooth survival in the oral cavity, between teeth treated with SCR and pulpotomy.

Conditions

  • Dental Caries

Interventions

OTHER

Selective Caries Removal

Selective caries are removed only for secure sealing with a direct restoration, without removing deep caries next to the pulp. If the pulp is exposed, pulpotomy will be performed instead and the tooth will be excluded from further analysis.

OTHER

Pulpotomy

Complete caries removal and excision of the coronal pulp to the level of the root canal orifices will be performed. After haemostasis, sealing with Biodentine® and restoration. If the pulp is not exposed after complete caries removal, the tooth will be restored without further excavation and pulp exposure. If the pulp is assessed intra-operatively to be non-vital or not amenable to pulpotomy, root canal treatment will be performed instead. In both cases, the tooth will be excluded from further analyses.

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Victoria Yu, PhD · National University Hosptial, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672070 on ClinicalTrials.gov