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CompletedNCT03845426TRAUMAUpdated Jun 4, 2020

Factors Affecting the Pulpal Prognosis of Injured Teeth

An observational study in Dental Trauma, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by University of Edinburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
16 Years and older
Sex
All
01

Study summary

Factors affecting the pulpal prognosis of injured teeth. Dental injuries may affect the survival of teeth. It is recommended to monitor the injured teeth at regular intervals to ensure that the appropriate treatment is delivered promptly. In order to conclude what treatment is required, a correct diagnosis must be reached.

However, reaching this diagnosis can be difficult as injured teeth often respond erroneously to many of the diagnostic tests used, thereby affecting our ability to interpret the results.

This study aims to identify the clinical factors that affect the ability of the blood supply of a tooth to survive an injury. This will help ensure that patients are provided with the appropriate treatment with the avoidance of delays that may affect the long-term survival of the tooth.

Patients that attend the Edinburgh Dental Institute trauma clinic will be invited to participate in this study. The patients, seen on this clinic, are assessed in regular intervals in a systematic way, as per accepted and validated international guidelines on the subject of dental trauma. There are specific investigations and clinical assessments that are carried out on the initial and each review appointment.

The study will attempt to identify those teeth that lose their vitality at different points following the injury and will attempt to link this to the nature of the injury suffered. The data will be collected from the patients' routine dental trauma assessment and no additional investigations will be required. As per routine practice the patients are reviewed for one year following their injury unless otherwise indicated. All responses to the investigations will be collected and combined to identify the prognostic factors associated with the loss of vitality of traumatised teeth.

Read the detailed description

Dento-alveolar trauma may affect the quality of life of patients and the long term prognosis of the teeth. Following dental trauma regular monitoring and follow up of the teeth is required to ensure that the appropriate treatment is delivered promptly. Although there is information in the literature focused on child and adolescent dental trauma, there is limited information regarding traumatised permanent teeth. Permanent teeth have differing healing capacity after injury and this is dependent on the degree of root formation.

During the initial assessment of patients that have suffered from dental trauma, negative responses to investigations assessing the health of the vasculature might lead clinicians to initiate unnecessary and irreversible treatment on traumatised teeth. Equally false positive results might delay treatment which might have an effect on the outcome, leading to the development of healing complications such as infection and root resorption. By collecting and analysing the clinical factors, we aim to identify which of aspects of the assessment might influence the prognoses of the teeth.

02

Conditions studied

  • Dental Trauma
03

In context

Lead sponsor

University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.

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

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients will be recruited from the dental trauma clinic, which runs every Monday in Edinburgh Dental Institute.

Inclusion criteria

  • patients that have suffered dental trauma (lateral luxation)
  • patients must have attended the Dental Trauma clinic within 2 weeks form the presenting injury
  • patients should re-attend for review and monitor of teeth for at least 3 months following the injury
  • patients older than 16 years old
  • patients that have signed the informed consent

Exclusion criteria

Exclusion Criteria:

  • patients presented more than 2 weeks following the injury
  • patients suffered from injuries other than lateral luxation
  • patients younger than 16 years old
  • adults with incapacity
  • patient that have not consented to take part
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • OtherRoot canal treatment.

    Once pulpal necrosis has been diagnosed, root canal treatment will be carried out by the patient's general practitioner. This is an end point for the tooth in the study.

06

What researchers measure

Primary outcomes

  1. Pulpal necrosis

    Number of participants developing pulpal necrosis following lateral luxations tooth injuries

    Time frame: 3 months

07

Study locations

1 site
  • Edinburgh Dental Institute
    Edinburgh, United Kingdom
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03845426
Lead sponsor
University of Edinburgh
Collaborators
NHS Lothian
Responsible party
Sponsor
First posted
Feb 19, 2019
Start date
Feb 25, 2019
Primary completion
Feb 1, 2020
Completion
Mar 1, 2020
Last update
Jun 4, 2020

Study contacts

Robert Philpott, BDS,
principal investigator · bob.philpott@ed.ac.uk

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 Jun 2020. You cannot join it, but the record below documents what was studied.

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