Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth

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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Trauma
• Intervention / Treatment: Device: Laser Doppler Flowmetry

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Nahar Ghouth, BDS; Phone Number: 0113 343 6228; Email: dnnng@leeds.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients attending the children's dentistry department at Leeds Dental Institute will be assessed for suitability in taking part into this study according to the study inclusion and exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity	One year follow up
Specificity	One year follow up

Collaborators and Investigators

• Sponsor: University of Leeds
• Investigators: Principal Investigator: Nahar Ghouth, University of Leeds

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: December 22, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No