Retrospective Cohort Study of Vital Pulp Therapy in Young Permanent Teeth

NCT ID: NCT02849600

Last Updated: 2016-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vital Pulp Therapy in Young Permanent Tooth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Vital pulp therapy,Young permanent tooth,Treatment outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subjects should be ASA I health person
2. 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
3. Subjects have returned for post-treatment clinical and radiographic examination follow up at least one year after treatment
Minimum Eligible Age

7 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yuan-Ling Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201507090RINC

Identifier Type: -

Identifier Source: org_study_id