Dental Pulp DiseaseEarly Phase 1NCT02137967
Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies
A Early Phase 1 study testing NaOCl pulpotomy, FC pulpotomy and 2.5% NaOCl in people with Dental Pulp Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 months to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Disease
- What is being tested?
- NaOCl pulpotomy, FC pulpotomy and 2.5% NaOCl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jun 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 months to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- children younger than 2.5 or older than 9 years of age
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Pediatric dental department, National Taiwan University Hospital
Taipei
Hsiao-Hua Chang, phD, 886-972651572, hhchangpedo@gmail.com
Hsiao-Hua Chang, phD
About this study
Official title: Clinical Evaluation of Sodium Hypochlorite Pulpotomies in Primary Molars: A Long-Term Follow-Up in Comparison With Conventional 20% Formocresol Pulpotomies
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.
Read the detailed description
As Brief summary.
- Conditions
- Dental Pulp Disease
- Being tested
- NaOCl pulpotomy, FC pulpotomy, 2.5% NaOCl, 20% Formocresol
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaOCl pulpotomyProcedure or surgery
Use 2.5% NaOCl as pulpotomy medicament for primary molars
FC pulpotomyProcedure or surgery
Use 20% Formocresol as pulpotomy medicament for primary molars
2.5% NaOClDrug
20% FormocresolDrug
| Study group | Role | What they receive |
|---|---|---|
| NaOCl pulpotomy | Experimental | Use 2.5% NaOCl as pulpotomy medication Receives: Procedure: NaOCl pulpotomy; Drug: 2.5% NaOCl |
| FC pulpotomy | Active comparator | Use 20% Formocresol as pulpotomy medicament Receives: Procedure: FC pulpotomy; Drug: 20% Formocresol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Secondary outcomes (1)
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
Measured: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startAug 2011
- Primary completionSep 2014 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Hua Chang, phD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137967
- Sponsor's protocol ID
- 201105091RB
- Status last verified
- May 2014
- First submitted
- 2 Jan 2012
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Sodium Hypochlorite Pulpotomies in Primary Molars: A Long-Term Follow-Up in Comparison With Conventional 20% Formocresol Pulpotomies
- ClinicalTrials.gov ID
- NCT02137967
- Acronym / sponsor ID
- 201105091RB
- Conditions
- Dental Pulp Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NaOCl pulpotomy | Experimental | Procedure: NaOCl pulpotomy, Drug: 2.5% NaOClUse 2.5% NaOCl as pulpotomy medication |
| FC pulpotomy | Active comparator | Procedure: FC pulpotomy, Drug: 20% FormocresolUse 20% Formocresol as pulpotomy medicament |
Who may qualify
- Ages
- 30 months to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- children younger than 2.5 or older than 9 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaOCl pulpotomyUse 2.5% NaOCl as pulpotomy medicament for primary molars | Procedure or surgery | NaOCl pulpotomy |
| FC pulpotomyUse 20% Formocresol as pulpotomy medicament for primary molars | Procedure or surgery | FC pulpotomy |
| 2.5% NaOCl | Drug | NaOCl pulpotomy |
| 20% Formocresol | Drug | FC pulpotomy |
Primary outcome
Change of Clinical Findings
Time frame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
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 1. Asymptomatic, clinical score=1 2. Slight discomfort: percussion sensitivity; mobility>1mm but<2mm, clinical score=2 3. Minor discomfort :long-lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility>2mm but<3mm, clinical score=3 4. 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
1 secondary outcome
Change of Radiographic Findings
Time frame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Hua Chang, phD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NaOCl pulpotomy, FC pulpotomy and 2.5% NaOCl in people with Dental Pulp Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Hua Chang, phD (886-972651572, hhchangpedo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Clinical Findings (time frame: At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.