Skip to main content
OpenTrials
Completed

NCT Number: NCT03490422

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulpotomy

Procedure

Pulpotomy in mature carious permanent teeth

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 6, 2018
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.