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

Plovdiv Medical University

Status: Unknown

Conditions: Trauma; Diagnosis Dual

Treatments: Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth

Study type: Interventional

Funder types: Other

Identifiers

NCT04967456

MedicalUniversity_Doppler

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Measurement of pulpal blood flow of traumatised tooth

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth

Measurement of pulpal blood flow of non-traumatised tooth

Other group

Description:

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.

Treatment:

Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth