Retrospective Cohort Study of Vital Pulp Therapy in Young Permanent Teeth

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10048
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 .

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success	clinical success: no clinical sympton and sign and tooth retained in oral cavity	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic success	radiographic success: complete healed of apical lesion, apical foramen closed, root increased in length, root canal wall increased in thickness	2 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yuan-Ling Lee, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Vital pulp therapy,Young permanent tooth,Treatment outcome
• Other Study ID Numbers: 201507090RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No