Efficacy of Laser Doppler Flowmetry as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth

Trauma Clinical Trial

Official title:

Efficacy of Laser Doppler Flowmetry, as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967456
• Other study ID #: MedicalUniversity_Doppler
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: August 2022

Study information

• Verified date: July 2021
• Source: Plovdiv Medical University
• Contact: Maria Shindova, PhD
• Phone: 003599898390935
• Email: mariya.shindova[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the efficacy of Laser Doppler flowmetry in determining the changes in the pulpal blood flow during the post-traumatic period of traumatised permanent teeth.

Description:

Traumatic injuries of permanent teeth in children and adolescents are very common. The conventional pulp vitality tests are inaccurate and unreliable techniques in assessing the pulp vitality during the post-traumatic period, as well as during the immature teeth examination. The aim is to evaluate the efficacy of Laser Doppler flowmetry in determining the changes in the pulpal blood flow during the post-traumatic period of traumatised permanent teeth. The study is designed as a randomized, split-mouth, controlled clinical trial. The measurement of the blood flow of the dental pulp of both, traumatised and non-traumatised teeth, will be performed, using a laser doppler flow monitor, emission wavelength 785nm±10nm, dual-channel laser Doppler monitoring option.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Fit and healthy subjects aged < 18-year-old;

2. Subjects with maxillary permanent incisor subjected to a traumatic injury without any dentoalveolar trauma involvement and have a contralateral homologous tooth with no signs/symptoms of injury;

3. Subjects attended their first dental visit within 3 days of the dental trauma;

4. Sensitivity value of the electric pulp test over 200 µA;

5. Subjects with at least one vital and non-traumatised maxillary incisor acting as a control tooth;

6. Ability to obtain a verbal acceptance from all the subjects to comply with all the treatments and follow-up timepoints attendance;

7. Ability to obtain written informed consent by the patients' parents/guardians for treatment, participation in the study and publication

Exclusion Criteria:

1. Subjects who were undergoing therapy for neurological conditions or with mental or cognitive problems;

2. Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7 days prior to the treatment commencement;

3. Subjects who have never had any first dental visit or treatment;

4. Subjects with systemic diseases or physiological development delay;

5. Subjects with active infectious diseases such as; influenza, scarlet fever, etc.

6. Subjects with restorations covered more than half the labial surface of the investigated teeth.

Related Conditions & MeSH terms

• Trauma

Intervention

Diagnostic Test:
• Measurement of pulpal blood flow of traumatised tooth
Measurement of the blood flow of the dental pulp will be performed, using a laser doppler flow monitor "mVMS-LDF2TM" (Moor Instruments Ltd Millwey Axminster Devon, UK), emission wavelength 785nm±10nm, dual-channel laser Doppler monitoring option. Two probes will be used, each consisting of one afferent and one efferent optic fiber to conduct the light to and from the tooth surface. The probe is stainless steel needle-like tube, which is 10-80 mm long and 1.5 mm in the diameter. The utilised parameter settings will be: Average power - 1.0 mV; Diameter of the probe - 1.5 mm; Frequency - 40 Hz; Monitoring time-180 seconds (sec)

Locations

Country	Name	City	State
Bulgaria	Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria	Plovdiv
Bulgaria	Medical University - Plovdiv, Bulgaria	Plovdiv

Sponsors (1)

Lead Sponsor	Collaborator
Plovdiv Medical University

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pulpal blood flow	The traumatised and non-traumatised teeth, test and control, will be assessed by LDF, providing an accurate and precise investigation. The temperature in the dental office will be constant and the patient will be seated in a "state position" in the dental chair. According to the manufacturer's recommendations, a patient's relaxation of 10 minutes before the monitoring process will be obtained. The measurements of blood flow will be performed for 180 seconds at each session. All the measurements will be recorded.	180 seconds