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

NCT04967456 | Unknown

• 1 other identifier: MedicalUniversity_Doppler
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Trauma; Diagnosis Dual

Keywords

Laser Doppler flowmetry; pulpal blood flow; pulp vitality; traumatised teeth; paediatric dentistry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Measurement of pulpal blood flow of traumatised tooth

ACTIVE COMPARATOR

In the split-mouth design, the traumatised maxillary incisor will be investigated using Laser Doppler flowmetry.

Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth

Measurement of pulpal blood flow of non-traumatised tooth

OTHER

In the split-mouth design, this arm - the non-traumatised maxillary incisor, contralateral tooth, will be investigated using Laser Doppler flowmetry as a control tooth.

Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth

Interventions

Measurement of pulpal blood flow of traumatised tooth DIAGNOSTIC_TEST

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)

Measurement of pulpal blood flow of non-traumatised tooth; Measurement of pulpal blood flow of traumatised tooth

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fit and healthy subjects aged \< 18-year-old;
• 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;
• Subjects attended their first dental visit within 3 days of the dental trauma;
• Sensitivity value of the electric pulp test over 200 μA;
• Subjects with at least one vital and non-traumatised maxillary incisor acting as a control tooth;
• Ability to obtain a verbal acceptance from all the subjects to comply with all the treatments and follow-up timepoints attendance;
• Ability to obtain written informed consent by the patients' parents/guardians for treatment, participation in the study and publication

You may not qualify if:

• Subjects who were undergoing therapy for neurological conditions or with mental or cognitive problems;
• Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7 days prior to the treatment commencement;
• Subjects who have never had any first dental visit or treatment;
• Subjects with systemic diseases or physiological development delay;
• Subjects with active infectious diseases such as; influenza, scarlet fever, etc.
• Subjects with restorations covered more than half the labial surface of the investigated teeth.

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (2)

Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria

Plovdiv, 4000, Bulgaria

RECRUITING

Medical University - Plovdiv, Bulgaria

Plovdiv, 4000, Bulgaria

RECRUITING

Related Publications (1)

• Belcheva A, Shindova M, Hanna R. Efficacy of Laser Doppler Flowmetry, as a Diagnostic Tool in Assessing Pulp Vitality of Traumatised Teeth: A Split Mouth Clinical Study. J Pers Med. 2021 Aug 17;11(8):801. doi: 10.3390/jpm11080801.

  PMID: 34442445 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Maria Shindova, PhD

  Plovdiv Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Shindova, PhD

CONTACT

003599898390935; mariya.shindova@gmail.com

Ani Belcheva, PhD

CONTACT

abeltcheva@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a randomized, split-mouth, controlled, clinical trial

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: July 9, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2)