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Retrospective Cohort Study of Vital Pulp Therapy in Young Permanent Teeth

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ClinicalTrials.gov Identifier: NCT02849600
Recruitment Status : Unknown
Verified July 2016 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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.

Condition or disease
Vital Pulp Therapy in Young Permanent Tooth

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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Cohort Study of Vital Pulp Therapy in Young Permanent Teeth
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016



Primary Outcome Measures :
  1. clinical success [ Time Frame: 2 year ]
    clinical success: no clinical sympton and sign and tooth retained in oral cavity


Secondary Outcome Measures :
  1. radiographic success [ Time Frame: 2 year ]
    radiographic success: complete healed of apical lesion, apical foramen closed, root increased in length, root canal wall increased in thickness



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 .
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849600


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10048
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yuan-Ling Lee, PhD National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02849600     History of Changes
Other Study ID Numbers: 201507090RINC
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Taiwan University Hospital:
Vital pulp therapy,Young permanent tooth,Treatment outcome