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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490422
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Victoria Yu, National University Health System, Singapore

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.

Condition or disease Intervention/treatment Phase
Pulpitis Pulp Exposure, Dental Pulp and Periapical Tissue Disease Procedure: Pulpotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors
Actual Study Start Date : October 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: Pulpotomy
Pulpotomy is performed in carious-exposed pulp in mature permanent teeth
Procedure: Pulpotomy
Pulpotomy in mature carious permanent teeth




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03490422


Sponsors and Collaborators
National University Health System, Singapore
Investigators
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Principal Investigator: Victoria Yu, PhD NUHS

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Responsible Party: Dr Victoria Yu, Associate Professor, National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT03490422    
Other Study ID Numbers: R-221-000-060-112
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Victoria Yu, National University Health System, Singapore:
pulpotomy
permanent teeth
deep caries management
risk factors
clinical indicators for pulpotomy
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Exposure
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases