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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2022-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Trauma Diagnosis Dual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a randomized, split-mouth, controlled, clinical trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Measurement of pulpal blood flow of traumatised tooth

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

Group Type ACTIVE_COMPARATOR

Measurement of pulpal blood flow of traumatised tooth

Intervention Type 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

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.

Group Type OTHER

Measurement of pulpal blood flow of traumatised tooth

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes