Back to resultsPulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
Primary Purpose
Pulpitis, Pulp Exposure, Dental, Pulp and Periapical Tissue Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulpotomy
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis focused on measuring pulpotomy, permanent teeth, deep caries management, risk factors, clinical indicators for pulpotomy
Eligibility Criteria
Inclusion Criteria:
Patient factors:
- Male and female at least 21 years of age
- Healthy and ambulant
- Mild diseases only and without substantive functional limitations
- Able to return for scheduled recalls
Tooth factors:
- Deep caries leading to pulp exposure
- With or without pre-operative spontaneous and/or aggravated pain
- Positive response to Cold and Electric Pulp Tests
- Positive bleeding on pulp exposure
- Haemostasis within 10 minutes
- Intact and continuous periodontal ligament space and dental lamina dura on radiograph
Exclusion Criteria:
Patient factors:
- Younger than 21 years of age
- Pregnant female
- Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension
Tooth factors:
- Extensive tooth structure loss requiring post and core retained restoration
- Uncontrolled periodontal disease
- Cracked tooth
- Traumatized tooth
- Haemostasis not achieved within 10 minutes
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulpotomy
Arm Description
Pulpotomy is performed in carious-exposed pulp in mature permanent teeth
Outcomes
Primary Outcome Measures
Change in radiographic apical status
Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years
Secondary Outcome Measures
Full Information
NCT ID
NCT03490422
First Posted
March 26, 2018
Last Updated
March 30, 2018
Sponsor
National University Health System, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03490422
Brief Title
Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
Official Title
Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This Trial evaluated the extent of pulp survival following pulpotomy in the permanent tooth pulp exposed by caries and identify potential risk factors for pulpal complications.
Detailed Description
Healthy patients ≥ 21 years old were recruited with informed consent. Inclusion criteria were symptomatic and asymptomatic periodontally sound teeth, positive response to pulp sensibility tests, pulp exposure by caries with bleeding, haemostasis achieved within 10 minutes and normal apical tissues. Under local anaesthesia and rubber dam isolation, caries was removed before pulpotomy. Pain complaint, clinical and radiographic data were collected during recalls for up to 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis, Pulp Exposure, Dental, Pulp and Periapical Tissue Disease
Keywords
pulpotomy, permanent teeth, deep caries management, risk factors, clinical indicators for pulpotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulpotomy
Arm Type
Experimental
Arm Description
Pulpotomy is performed in carious-exposed pulp in mature permanent teeth
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy
Intervention Description
Pulpotomy in mature carious permanent teeth
Primary Outcome Measure Information:
Title
Change in radiographic apical status
Description
Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient factors:
Male and female at least 21 years of age
Healthy and ambulant
Mild diseases only and without substantive functional limitations
Able to return for scheduled recalls
Tooth factors:
Deep caries leading to pulp exposure
With or without pre-operative spontaneous and/or aggravated pain
Positive response to Cold and Electric Pulp Tests
Positive bleeding on pulp exposure
Haemostasis within 10 minutes
Intact and continuous periodontal ligament space and dental lamina dura on radiograph
Exclusion Criteria:
Patient factors:
Younger than 21 years of age
Pregnant female
Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension
Tooth factors:
Extensive tooth structure loss requiring post and core retained restoration
Uncontrolled periodontal disease
Cracked tooth
Traumatized tooth
Haemostasis not achieved within 10 minutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Yu, PhD
Organizational Affiliation
NUHS
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
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