Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth

NCT03005197 | Unknown

• 1 other identifier: 1
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Trauma

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  One year follow up

• Specificity

  One year follow up

Interventions

Laser Doppler Flowmetry DEVICE

Also known as: LDF

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Interventions

Laser-Doppler Flowmetry

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Study Officials

• Nahar Ghouth

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahar Ghouth, BDS

CONTACT

0113 343 6228; dnnng@leeds.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investogator

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: December 29, 2016
• Study Start: February 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 5, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share