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Clinical Trials/NCT03490422
NCT03490422
Completed
Not Applicable

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

National University Health System, Singapore0 sites53 target enrollmentStarted: October 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
National University Health System, Singapore
Enrollment
53
Primary Endpoint
Change in radiographic apical status

Overview

Brief Summary

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.

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
National University Health System, Singapore
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Victoria Yu

Associate Professor

National University Health System, Singapore

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