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CompletedNCT03490422Updated Apr 6, 2018

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

An interventional study of Pulpotomy in Pulpitis, Pulp Exposure, Dental and Pulp and Periapical Tissue Disease, sponsored by National University Health System, Singapore. Completed. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-06.

Sponsored by National University Health System, Singapore · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Oct 2013, registered Mar 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulpitis
  • Pulp Exposure, Dental
  • Pulp and Periapical Tissue Disease

Keywords

  • pulpotomy
  • permanent teeth
  • deep caries management
  • risk factors
  • clinical indicators for pulpotomy
03

In context

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's enrollment of 53 is below the median of 64 across 288 interventional studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

National University Health System, Singapore is the lead sponsor of 42 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Pulpotomy

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

    Procedure: Pulpotomy

Interventions

  • ProcedurePulpotomy

    Pulpotomy in mature carious permanent teeth

06

What researchers measure

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

    Time frame: 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2013 to primary completion in Jul 2014, 9 months.

Of 158 non-industry interventional studies with no phase under Pulpitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's 9 months is below that.

Counting every sponsor, half of 158 studies reached it within 16 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 26, 2018
First posted
Apr 6, 2018
StartActual
Oct 2013
Primary completionActual
Jul 2014
CompletionActual
Jul 2014
Last update
Apr 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03490422
Lead sponsor
National University Health System, Singapore
Responsible party
Dr Victoria Yu (Associate Professor, National University Health System, Singapore) — Principal investigator
First posted
Apr 6, 2018
Start date
Oct 2013
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Apr 6, 2018

Study contacts

Victoria Yu, PhD
principal investigator · NUHS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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