Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2014

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.

Interventions

  • Procedure: Pulpotomy
    • Pulpotomy in mature carious permanent teeth

Arms, Groups and Cohorts

  • Experimental: Pulpotomy
    • Pulpotomy is performed in carious-exposed pulp in mature permanent teeth

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

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: – 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 Exclusion Criteria:

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 – Uncontrolled periodontal disease – Cracked tooth – Traumatized tooth – Haemostasis not achieved within 10 minutes

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National University Health System, Singapore
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Victoria Yu, Associate Professor – National University Health System, Singapore
  • Overall Official(s)
    • Victoria Yu, PhD, Principal Investigator, NUHS

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