Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
Primary Purpose
Dental Pulp Disease
Status
Unknown status
Phase
Early Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
NaOCl pulpotomy
FC pulpotomy
2.5% NaOCl
20% Formocresol
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pulp Disease
Eligibility Criteria
Inclusion Criteria:
- healthy, American Society of Anesthesiologists (ASA) Physical Status classification system class I children
- age between 2.5 and 9 years old
- with one or more primary molars need pulpotomy treatment
Exclusion Criteria:
- children younger than 2.5 or older than 9 years of age
Sites / Locations
- Pediatric dental department, National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NaOCl pulpotomy
FC pulpotomy
Arm Description
Use 2.5% NaOCl as pulpotomy medication
Use 20% Formocresol as pulpotomy medicament
Outcomes
Primary Outcome Measures
Change of Clinical Findings
The outcome will be assessed first by clinical findings. We can discriminate the result are successful or not by scoring the clinical finding from 1 to 4 .
Criteria for clinical scoring
Asymptomatic, clinical score=1
Slight discomfort: percussion sensitivity; mobility>1mm but<2mm, clinical score=2
Minor discomfort :long-lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility>2mm but<3mm, clinical score=3
major discomfort: Late pathological changes; spontaneous pain; periodontal pocket formation with exudate; sinus tract; mobility≧3 mm; premature tooth loss due to pathology, clinical score=4
Secondary Outcome Measures
Change of Radiographic Findings
The outcome will be assessed then by radiographic findings. We can discriminate the result are successful or not by scoring the radiographic findings from1 to 5.
Criteria for radiographic scoring
Dentinal bridge, clinical score=1, regeneration tissue response
No change, clinical score=2, no pathological changes
Pulp canal obliteration, clinical score=3, slight pathological changes, no clinical significance
Periodontal ligament widening, clinical score=3, slight pathological changes, no clinical significance
Internal root resorption (non-perforated), clinical score=4, minor pathological changes
External root resorption, clinical score=4, minor pathological changes
Internal root resorption (perforated), clinical score=4, minor pathological changes
Peri-radicular lesion, clinical score=5, major pathological changes, treatment needed
Full Information
NCT ID
NCT02137967
First Posted
January 2, 2012
Last Updated
May 13, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02137967
Brief Title
Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
Official Title
Clinical Evaluation of Sodium Hypochlorite Pulpotomies in Primary Molars: A Long-Term Follow-Up in Comparison With Conventional 20% Formocresol Pulpotomies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in the primary teeth. However, concerns have been raised over the use of FC because of its toxicity and potential carcinogenicity. A substitution for FC has been investigated but evidence is lacking to conclude which is the most appropriate technique for pulpotomies in primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more than 80 years, and it is at present the most popular irrigant in root canal treatment. Studies have showed that NaOCl is biological compatible and is a very good antimicrobial solution without being a pulpal irritant. Recent studies using sodium hypochlorite as pulpotomy medicament in primary molars showed promising results. In this project, the investigators propose a randomized clinical trial, which will be performed in Pediatric Dentistry Department of the National Taiwan University Hospital, to compare the treatment outcomes between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim of this sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to 9 year-old, who have at least one primary first or second molars diagnosed to receive pulpotomy treatment will be recruited in this project. The involved teeth will be randomly assigned to the control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth will be clinically and radiographically evaluated by blinded independent evaluators to the treatment group. The differences will be statistically analyzed using chi-square test, Fisher exact test, and t-test, using a statistical significance at p<0.05.
Detailed Description
As Brief summary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NaOCl pulpotomy
Arm Type
Experimental
Arm Description
Use 2.5% NaOCl as pulpotomy medication
Arm Title
FC pulpotomy
Arm Type
Active Comparator
Arm Description
Use 20% Formocresol as pulpotomy medicament
Intervention Type
Procedure
Intervention Name(s)
NaOCl pulpotomy
Intervention Description
Use 2.5% NaOCl as pulpotomy medicament for primary molars
Intervention Type
Procedure
Intervention Name(s)
FC pulpotomy
Intervention Description
Use 20% Formocresol as pulpotomy medicament for primary molars
Intervention Type
Drug
Intervention Name(s)
2.5% NaOCl
Intervention Type
Drug
Intervention Name(s)
20% Formocresol
Primary Outcome Measure Information:
Title
Change of Clinical Findings
Description
The outcome will be assessed first by clinical findings. We can discriminate the result are successful or not by scoring the clinical finding from 1 to 4 .
Criteria for clinical scoring
Asymptomatic, clinical score=1
Slight discomfort: percussion sensitivity; mobility>1mm but<2mm, clinical score=2
Minor discomfort :long-lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility>2mm but<3mm, clinical score=3
major discomfort: Late pathological changes; spontaneous pain; periodontal pocket formation with exudate; sinus tract; mobility≧3 mm; premature tooth loss due to pathology, clinical score=4
Time Frame
At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Secondary Outcome Measure Information:
Title
Change of Radiographic Findings
Description
The outcome will be assessed then by radiographic findings. We can discriminate the result are successful or not by scoring the radiographic findings from1 to 5.
Criteria for radiographic scoring
Dentinal bridge, clinical score=1, regeneration tissue response
No change, clinical score=2, no pathological changes
Pulp canal obliteration, clinical score=3, slight pathological changes, no clinical significance
Periodontal ligament widening, clinical score=3, slight pathological changes, no clinical significance
Internal root resorption (non-perforated), clinical score=4, minor pathological changes
External root resorption, clinical score=4, minor pathological changes
Internal root resorption (perforated), clinical score=4, minor pathological changes
Peri-radicular lesion, clinical score=5, major pathological changes, treatment needed
Time Frame
At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy, American Society of Anesthesiologists (ASA) Physical Status classification system class I children
age between 2.5 and 9 years old
with one or more primary molars need pulpotomy treatment
Exclusion Criteria:
children younger than 2.5 or older than 9 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao-Hua Chang, phD
Phone
886-972651572
Email
hhchangpedo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao-Hua Chang, phD
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric dental department, National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao-Hua Chang, phD
Phone
886-972651572
Email
hhchangpedo@gmail.com
First Name & Middle Initial & Last Name & Degree
Hsiao-Hua Chang, phD
12. IPD Sharing Statement
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Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
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