Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth

• Conditions: Dental Trauma

• Registration Number: NCT03005197
• Lead Sponsor: University of Leeds

Brief 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.

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 Timeline

• Study First Submitted: 2016-12-22
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05
• Study Start: 2017-02
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity	One year follow up
Specificity	One year follow up