PulpitisNCT03490422
Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
A study testing Pulpotomy in people with Pulpitis and Pulp Exposure, Dental, run by National University Health System, Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulpitis, Pulp Exposure, Dental, Pulp and Periapical Tissue Disease
- What is being tested?
- Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jul 2014
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Uncontrolled periodontal disease
- Cracked tooth
- Traumatized tooth
- Haemostasis not achieved within 10 minutes
About this study
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.
Read the 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.
- Being tested
- Pulpotomy
- Keywords
- pulpotomy, permanent teeth, deep caries management, risk factors, clinical indicators for pulpotomy
- Medical subject headings
- Pulpitis, Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Pulpotomy in mature carious permanent teeth
| Study group | Role | What they receive |
|---|---|---|
| Pulpotomy | Experimental | Pulpotomy is performed in carious-exposed pulp in mature permanent teeth Receives: Procedure: Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in radiographic apical status
Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study startOct 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Victoria Yu, National University Health System, Singapore
- Investigators
- Victoria Yu, PhD, Principal investigator, NUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490422
- Sponsor's protocol ID
- R-221-000-060-112
- Status last verified
- Mar 2018
- First submitted
- 26 Mar 2018
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
- ClinicalTrials.gov ID
- NCT03490422
- Acronym / sponsor ID
- R-221-000-060-112
- Keywords
- pulpotomy, permanent teeth, deep caries management, risk factors, clinical indicators for pulpotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Apr 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulpotomy | Experimental | Procedure: PulpotomyPulpotomy is performed in carious-exposed pulp in mature permanent teeth |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Deep caries leading to pulp exposure
Key exclusion criteria (10 listed)
- Younger than 21 years of age
- Pregnant female
- Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension
- Extensive tooth structure loss requiring post and core retained restoration
- Uncontrolled periodontal disease
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 |
|---|---|---|
| PulpotomyPulpotomy in mature carious permanent teeth | Procedure or surgery | Pulpotomy |
Primary outcome
Change in radiographic apical status
Time frame: 3 years
Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Victoria Yu, PhD principal investigator
NUHS
Questions about this trial
What is this clinical trial studying?
A study testing Pulpotomy in people with Pulpitis and Pulp Exposure, Dental, run by National University Health System, Singapore.
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 12 inclusion and 10 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: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in radiographic apical status (time frame: 3 years). 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 6 Apr 2018.