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

July 8, 2021 updated by: Plovdiv Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
        • Contact:
        • Contact:
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • Medical University - Plovdiv, Bulgaria
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Measurement of pulpal blood flow of traumatised tooth
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 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)
Other: Measurement of pulpal blood flow of non-traumatised tooth
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in pulpal blood flow
Time Frame: 180 seconds
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plovdiv Medical University

Investigators

  • Principal Investigator: Maria Shindova, PhD, Plovdiv Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MedicalUniversity_Doppler

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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