TrialReader


Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth

NCT03005197 — Unknown, 30 participants, University of Leeds

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Prospective Study to Assess the Diagnostic Accuracy of Laser Doppler Flowmetry in Assessing Pulp Vitality of Traumatised Teeth in Paediatric Patients

RegistryNCT03005197
StatusUnknown
Study typeObservational
Enrollment30 (Estimated)
SponsorUniversity of Leeds (Other)
ConditionsDental Trauma
InterventionsLaser Doppler Flowmetry (Device)
Datesstart 2017-02-01, primary completion 2018-05-01 (estimated), completion 2018-05-01 (estimated), first posted 2016-12-29, last updated 2017-01-05

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Dental Trauma All trials of Laser Doppler Flowmetry

-Summary

Teeth injuries are considered one of the most challenging events that occur in dentistry, especially in children. After an injury, there is a possibility that the blood supply to the tooth may become affected and compromised leading to nerve and blood vessels death with the tooth described as a non-vital tooth.

The conventional diagnostic tools available to assess tooth nerve/blood supply are not always reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or de-vitalising a normal tooth which may render the tooth weak for the future and possibly losing the tooth.

The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more reliable than the traditional techniques. We aim to assess if this device can predict and assess whether the tooth is alive or dead during the follow up visits of the injury along the other conventional tests.

Expand all sections  ·  Collapse all

+Detailed description

A clinical study will be carried out which consists of a one year follow up to monitoring traumatised front teeth in children attending the department of paediatric dentistry.

The vitality/sensibility of traumatised teeth will be assessed using laser Doppler flowmetry, electrical pulp testing and ethyl chloride. Measurements will be performed by a single operator (chief investigator) and will be carried out at baseline, 3, 6, 9 and 12 months follow up period.

+Arms and interventions

  • Laser Doppler Flowmetry (Device), also known as LDF

+Outcome measures

Primary outcomes

  • Sensitivity [One year follow up]
  • Specificity [One year follow up]

+Eligibility

Sex: All, ages: 6 Years to 16 Years, accepts healthy volunteers

Children would be recruited into this study when they:

* Between 6-16 years old.
* Medically fit (ASA I, II).
* Able to communicate using English language.
* Have an acceptable level of cooperation.
* Have at least one traumatised anterior tooth, regardless of the type of trauma, with uncertain pulpal vitality requiring monitoring for a minimum of 12 months and minimal coronal restoration (covering less than half the labial crown surface).
* Have at least one vital and non-traumatised anterior tooth to act as a control.

Exclusion Criteria:

* Medically and mentally compromised children.
* Children with learning disabilities.
* Children with communication barrier including those unable to communicate using English language.
* Heavily restored teeth covering more than half the labial surface of teeth.
* Patients on routine analgesics, antidepressants or antihypertensive drugs.
* Vital teeth with pulp canal obliteration.

+Publications

  • Jafarzadeh H. Laser Doppler flowmetry in endodontics: a review. Int Endod J. 2009 Jun;42(6):476-90. doi: 10.1111/j.1365-2591.2009.01548.x. PMID 19459999

+Investigators

My Notes