NCT03490422

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
Last Updated

April 6, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 26, 2018

Last Update Submit

March 30, 2018

Conditions

PulpitisPulp Exposure, DentalPulp and Periapical Tissue Disease

Keywords

pulpotomypermanent teethdeep caries managementrisk factorsclinical indicators for pulpotomy

Outcome Measures

Primary Outcomes (1)

  • Change in radiographic apical status

    Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years

    3 years

Study Arms (1)

Pulpotomy

EXPERIMENTAL

Pulpotomy is performed in carious-exposed pulp in mature permanent teeth

Procedure: Pulpotomy

Interventions

PulpotomyPROCEDURE

Pulpotomy in mature carious permanent teeth

Pulpotomy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PulpitisDental Pulp Exposure

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Victoria Yu, PhD

    NUHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 6, 2018

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

April 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share