Vital Pulp Therapy in Young Permanent ToothNCT02849600
Retrospective Cohort Study of Vital Pulp Therapy in Young Permanent Teeth
An observational study of Vital Pulp Therapy in Young Permanent Tooth, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This is a retrospective cohort study with two specific aims. The first aim focuses on the treatment outcome of different VPT protocols in young permanent tooth. The second aim is to determine if MTA is a suitable material in VPT and related factors potentially influencing prognosis. Read more about this study
- Who is it for?
- Ages 7 to 35 years
- Conditions the study is for
- Vital Pulp Therapy in Young Permanent Tooth
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2015to Dec 2016
- Phase
- Observational
- 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 7 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The patients who have young permanent tooth and received vital pulp therapy at the Department of Dentistry in the National Taiwan University Hospital from 1999 to 2014 .
- Subjects should be ASA I health person
- Subject have at least one young permanent tooth received vital pulp therapy, including direct pulp capping, partial pulpotomy, full pulpotomy, partial pulpectomy, apexification and pulp revascularization
- Subjects have returned for post-treatment clinical and radiographic examination follow up at least one year after treatment
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective cohort study with two specific aims. The first aim focuses on the treatment outcome of different VPT protocols in young permanent tooth. The second aim is to determine if MTA is a suitable material in VPT and related factors potentially influencing prognosis.
Read the detailed description
Unlike fully developed teeth, the root canal treatment of young permanent teeth is particularly complex and difficult due to its large apical opening, short root length and thin canal wall. In modern endodontics, vital pulp therapy (VPT), a biological based procedures designed to restore functional pulp-dentin complex and promote continued root development, has been considered as an alternative treatment modality. Mineral Trioxide Aggregate (MTA) has been recommended for uses in VPT with preliminary studies, showing promising results. However, lack of high level of evidence trials, inconsistent treatment protocols and follow-up periods, heterogeneous selection criteria, result VPT unreliable and difficult to reach a consensus on the efficacy of MTA. Therefore, we propose this retrospective cohort study with two specific aims. The first aim focuses on the treatment outcome of different VPT protocols in young permanent tooth. The second aim is to determine if MTA is a suitable material in VPT and related factors potentially influencing prognosis. Subjects for the study will be identified from patients who received VPT at the Department of Dentistry in the National Taiwan University Hospital from 1999 to 2014 and have returned for tooth follow up at least one year after treatment. Treatment outcomes will be judged by analyzing clinical and radiographic data, which will be evaluated by 3 independent dentists. The radiographs will be evaluated using a geometrical imaging program-NIH Image J, to calculate the percentage increase in root length and width. Statistical analysis will be applied using the SPSS program to assess the treatment's success rates at the various follow-up periods. The differences will be statistically analyzed performing chi-square test, Fisher exact test, and t-test, using a statistical significance at p<0.05.
- Keywords
- Vital pulp therapy,Young permanent tooth,Treatment outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success
clinical success: no clinical sympton and sign and tooth retained in oral cavity
Measured: 2 year
Secondary outcomes (1)
radiographic success
radiographic success: complete healed of apical lesion, apical foramen closed, root increased in length, root canal wall increased in thickness
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital Pulp Therapy in Young Permanent ToothStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Ling Lee, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849600
- Sponsor's protocol ID
- 201507090RINC
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study of Vital Pulp Therapy in Young Permanent Teeth
- ClinicalTrials.gov ID
- NCT02849600
- Acronym / sponsor ID
- 201507090RINC
- Keywords
- Vital pulp therapy,Young permanent tooth,Treatment outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Jul 2016 (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.
This is a retrospective cohort study with two specific aims. The first aim focuses on the treatment outcome of different VPT protocols in young permanent tooth. The second aim is to determine if MTA is a suitable material in VPT and related factors potentially influencing prognosis.
Detailed description
Unlike fully developed teeth, the root canal treatment of young permanent teeth is particularly complex and difficult due to its large apical opening, short root length and thin canal wall. In modern endodontics, vital pulp therapy (VPT), a biological based procedures designed to restore functional pulp-dentin complex and promote continued root development, has been considered as an alternative treatment modality. Mineral Trioxide Aggregate (MTA) has been recommended for uses in VPT with preliminary studies, showing promising results. However, lack of high level of evidence trials, inconsistent treatment protocols and follow-up periods, heterogeneous selection criteria, result VPT unreliable and difficult to reach a consensus on the efficacy of MTA. Therefore, we propose this retrospective cohort study with two specific aims. The first aim focuses on the treatment outcome of different VPT protocols in young permanent tooth. The second aim is to determine if MTA is a suitable material in VPT and related factors potentially influencing prognosis. Subjects for the study will be identified from patients who received VPT at the Department of Dentistry in the National Taiwan University Hospital from 1999 to 2014 and have returned for tooth follow up at least one year after treatment. Treatment outcomes will be judged by analyzing clinical and radiographic data, which will be evaluated by 3 independent dentists. The radiographs will be evaluated using a geometrical imaging program-NIH Image J, to calculate the percentage increase in root length and width. Statistical analysis will be applied using the SPSS program to assess the treatment's success rates at the various follow-up periods. The differences will be statistically analyzed performing chi-square test, Fisher exact test, and t-test, using a statistical significance at p<0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 7 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The patients who have young permanent tooth and received vital pulp therapy at the Department of Dentistry in the National Taiwan University Hospital from 1999 to 2014 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical success
Time frame: 2 year
clinical success: no clinical sympton and sign and tooth retained in oral cavity
1 secondary outcome
radiographic success
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Individual participant dataSharing planned: No
Related trials for Vital Pulp Therapy in Young Permanent Tooth
Active, not recruiting
Clinical Evaluation and Cone Beam Computed Tomography Analysis of Different Biomaterials for Apexogenesis of Immature Permanent Molars
Vital Pulp Therapy in Young Permanent Tooth
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.
Yuan-Ling Lee, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Pulp Therapy in Young Permanent Tooth, 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?
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 29 Jul 2016. 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.
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?
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?
clinical success (time frame: 2 year). 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 29 Jul 2016.