Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth

Dental Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03005197
• Other study ID #: 1
• Status: Not yet recruiting
• Phase: N/A
• First received: December 22, 2016
• Last updated: January 4, 2017
• Start date: February 2017
• Est. completion date: May 2018

Study information

• Verified date: January 2017
• Source: University of Leeds
• Contact: Nahar Ghouth, BDS
• Phone: 0113 343 6228
• Email: dnnng[@]leeds.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dental Trauma

Intervention

Device:
• Laser Doppler Flowmetry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity		One year follow up	No
Primary	Specificity		One year follow up	No