Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis
Primary Purpose
Dental Caries
Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Selective Caries Removal
Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring vital pulp therapy, selective caries removal, pulpotomy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- National University Hospital, Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Selective Caries Removal
Pulpotomy
Arm Description
The patient will be treated with Selective Caries Removal (SCR)
The patient will be treated with full coronal Pulpotomy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Tooth restorative treatment costs
Measuring the total treatment costs (including for treatments that were not originally planned for, e.g. crown required after tooth fractured 2 years later) for the tooth over the 5 year evaluation period
Tooth survival in the oral cavity
Measuring if the tooth survived without extraction over the 5 year evaluation, and the time to extraction if relevant.
Number of treatment visits spent for treatment
Measuring the number of treatment visits (including unscheduled visits) for the tooth over the 5 year evaluation period
Treatment time spent for treatment
Measuring the treatment time required (including for unscheduled visits) for the tooth over the 5 year evaluation period
Full Information
NCT ID
NCT04672070
First Posted
March 22, 2020
Last Updated
July 13, 2023
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT04672070
Brief Title
Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis
Official Title
A Randomised Clinical Trial to Test the Efficacy of Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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 extending deep to reach the pulp will be excluded from the Study. Recruitment will continue until the target sample size in each group is attained , up to a maximum of 120 teeth (surplus to account for teeth that are not able to complete the allocated treatment).
Investigators trained in SCR and Pulpotomy will perform both treatment procedures.
For patients with multiple teeth with deep carious lesions suitable for this study, the unit of randomisation will be the individual tooth and not the patient. If it is not possible to perform treatment on all the teeth in the same visit, the operator will start on the tooth which displays the deepest lesion measured radiographically and according to clinically exigencies.
In the event of emergency/unscheduled return visits due to pain, the patient's treatment notes will be made available to the attending dentist and emergency treatment rendered as appropriate (e.g. root canal treatment). This tooth and its relevant research data will be included as an event in the survival analysis but the tooth will be discontinued from the Trial.
Study Visits and Procedures Dental clinicians at National University Polyclinic (NUP) Dental Clinics and NUCOHS will follow a case selection template for patient referral. Timeframe for recruitment is up to 6months after referral to NUCOHS. The patients will be provided standard of care by their dentists according to the respective Institutional Practice, which may include Oral Health Education, Oral Health Instruction and/or scaling and polishing.
Consent: Patients will be informed of the Study at their first visit to NUCOHS and given time to consider participation and ask questions. Written informed consent will be obtained before proceeding to Screening.
Screening and Enrolment: Clinical and radiographic examination in line with current clinical practice to save teeth with deep caries will be conducted. When inclusion and exclusion criteria are fulfilled, the tooth will be enrolled into the study. One patient may contribute more than one tooth.
Randomisation: This will be performed after tooth is enrolled.
Treatment - SCR or Pulpotomy: After allocation to SCR or Pulpotomy, in both groups, interventions will be performed in a single visit under local anaesthesia and rubber dam isolation. Caries will be removed using high speed burs with water coolant starting from the periphery.
In the SCR group, selective caries are removed only for secure sealing with a direct restoration, without removing deep caries next to the pulp.
In the Pulpotomy group, 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.
In either group, if the tooth is unable to complete the allocated treatment, this tooth will be excluded from the study.
In both groups, direct restoration (e.g. composite resin or amalgam) or crowns will be provided based on remaining tooth structure, number of remaining functioning units, location of the tooth and its opposing counterpart.
Review Appointments: Four Review visits will be conducted at the following time points:
6-7 months post treatment
12- 13 months post treatment
36-37 months post treatment
60-61 months post treatment
Data Collection:
Baseline data will include:
Relevant pain history
Clinical examination of the tooth, pulp and surrounding bone and mucosa
Routine dental radiographic examination for tooth restoration
After treatment is completed, the following treatment data will include:
Time to achieve haemostasis for teeth in the pulpotomy group
Time taken for the procedure
Type of restoration placed
Cost of treatment
Cumulative time spent at the dental clinic to complete treatment
At follow-up appointments, the review data will include:
Relevant pain history since the last visit
Clinical examination of the tooth, pulp and surrounding bone and mucosa
Routine dental radiographic examination to evaluate supporting bone response to the preserved pulp
Relevant additional procedures for teeth during review period if needed (e.g. replacement of restoration)
Cumulative treatment fees charged to preserve teeth (since enrolment)
Cumulative number of treatment visits (including any additional procedures during the review period, if any)
Statistical and Analytical Plans Unit of analysis is per tooth level. Descriptive analysis (mean & standard deviation and frequency and proportion, where appropriate) will be performed to summarize the baseline characteristics of recruited subjects between the two treatment groups. To study the primary objective - comparing the tooth survival without pulp pathosis between the two treatment groups at 6 months, 1 year, 3 years and 5 years, proportional z-test will be performed.
Generalized estimating equation (GEE) with binomial family distribution and log link function will be employed to study the change in tooth survival over the study follow-up period. Potential confounders and clinical predictors will be adjusted in the model.
Significance level for all statistical test is set at p-value<0.05. SPSS Statistical Package (IBM SPSS Statistics) will be used for all statistical analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
vital pulp therapy, selective caries removal, pulpotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selective Caries Removal
Arm Type
Active Comparator
Arm Description
The patient will be treated with Selective Caries Removal (SCR)
Arm Title
Pulpotomy
Arm Type
Active Comparator
Arm Description
The patient will be treated with full coronal Pulpotomy.
Intervention Type
Other
Intervention Name(s)
Selective Caries Removal
Other Intervention Name(s)
indirect pulp capping, partial caries removal
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pulpotomy
Other Intervention Name(s)
full pulpotomy, coronal pulpotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of teeth requiring Root Canal Treatment or Extraction
Description
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.
Time Frame
6 months, 1 year, 3 years, 5 years
Secondary Outcome Measure Information:
Title
Tooth restorative treatment costs
Description
Measuring the total treatment costs (including for treatments that were not originally planned for, e.g. crown required after tooth fractured 2 years later) for the tooth over the 5 year evaluation period
Time Frame
5 years
Title
Tooth survival in the oral cavity
Description
Measuring if the tooth survived without extraction over the 5 year evaluation, and the time to extraction if relevant.
Time Frame
5 years
Title
Number of treatment visits spent for treatment
Description
Measuring the number of treatment visits (including unscheduled visits) for the tooth over the 5 year evaluation period
Time Frame
5 years
Title
Treatment time spent for treatment
Description
Measuring the treatment time required (including for unscheduled visits) for the tooth over the 5 year evaluation period
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Yu, PhD
Organizational Affiliation
National University Hosptial, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital, Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Selective Caries Removal (SCR) Versus Pulpotomy in Preventing Pulp Necrosis and Apical Periodontitis
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