Status:
UNKNOWN
Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Dental Caries
Eligibility:
All Genders
21-65 years
Phase:
NA
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 (NUCOH...
Detailed Description
1. Randomisation and Blinding Teeth will be randomised to receive either SCR or Pulpotomy blindly, with 50 teeth in each group. Teeth allocated to Pulpotomy that do not subsequently have caries extend...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04672070
Start Date
May 31 2019
End Date
June 30 2025
Last Update
July 14 2023
Active Locations (1)
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1
National University Hospital, Singapore
Singapore, Singapore, 119074