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

NCT04672070 | Unknown DMC

• 1 other identifier: DSRB 2018/01360
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

vital pulp therapy; selective caries removal; pulpotomy

Outcome Measures

Primary Outcomes (1)

• Number of teeth requiring Root Canal Treatment or Extraction

  Efficacy of selective caries removal (SCR) and pulpotomy in preventing pulp necrosis and apical periodontitis (thus sparing patient from root canal treatment or extraction) will be measured. Pulp pathosis (defined by presence of pain, swelling, or radiographic periapical radiolucency, necessitating root canal treatment or extraction) will be recorded for teeth in each arm.

  6 months, 1 year, 3 years, 5 years

Secondary Outcomes (4)

• Tooth restorative treatment costs

  5 years

• Tooth survival in the oral cavity

  5 years

• Number of treatment visits spent for treatment

  5 years

• Treatment time spent for treatment

  5 years

Study Arms (2)

Selective Caries Removal

ACTIVE COMPARATOR

The patient will be treated with Selective Caries Removal (SCR)

Other: Selective Caries Removal

Pulpotomy

ACTIVE COMPARATOR

The patient will be treated with full coronal Pulpotomy.

Other: Pulpotomy

Interventions

Selective Caries Removal OTHER

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.

Also known as: indirect pulp capping, partial caries removal

Selective Caries Removal

Pulpotomy OTHER

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.

Also known as: full pulpotomy, coronal pulpotomy

Pulpotomy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting at National University Polyclinics (NUP) Dental Clinics or NUCOHS general dentistry clinics
• Aged between 21-65 years old
• Deep primary or secondary caries diagnosed on radiograph as being at least 2/3 into the thickness of dentine
• Permanent tooth with mature apices
• ASA I and II (American Society of Anesthesiologists Physical Status Classification System)
• Willing to commit to dental health education (DHE), oral hygiene instructions (OHI), restoration, and reviews of treatment completed
• Positive response to cold test with Endo-Ice® (non-lingering beyond 2 minutes) and electric pulp testing

You may not qualify if:

• Spontaneous and/or continuous pain associated with the carious tooth
• Pulp exposure present
• Tooth requires a post-retained core for restoration
• Tooth is required to support a fixed or removable partial denture
• Tooth with localized severe periodontitis (mobility grade ≥ 2 and/or periodontal pocket ≥ 5mm)
• Teeth with periapical lesion (defined as periapical radiolucency in connection with the apical part of the root where the width of the radiolucent lesion exceeds twice the width of the periodontal ligament space)
• Tooth needs to be extracted
• Tooth with occlusal trauma or occlusal overload (e.g. denture abutment tooth)
• Tooth is unable to complete allocated treatment
• Self-declared pregnancy
• Patient is unable to give consent (e.g. cognitively impaired person)

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

Related Publications (1)

• Chew JJR, Tan SHX, Chua SKX, Lui JN, Sim YF, Yu VSH. Three-Year Clinical and Economic Evaluation of Selective Caries Removal and Full Pulpotomy for Extensive Caries: An Exploratory Randomised Controlled Trial. Int Endod J. 2025 Nov 25. doi: 10.1111/iej.70068. Online ahead of print.

  PMID: 41288117 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Victoria Yu, PhD

  National University Hosptial, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be done to the outcomes assessors to reduce bias during radiographic healing assessment. Participants also will not be informed of which treatment they are undergoing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.

Study Record Dates

• First Submitted: March 22, 2020
• First Posted: December 17, 2020
• Study Start: May 31, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)