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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Shindova, PhD | Contact | 003599898390935 | mariya.shindova@gmail.com | |
| Ani Belcheva, PhD | Contact | abeltcheva@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Shindova, PhD | Plovdiv Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria | Recruiting | Plovdiv | 4000 | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34442445 | Derived | 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. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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a randomized, split-mouth, controlled, clinical trial
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| Medical University - Plovdiv, Bulgaria | Recruiting | Plovdiv | 4000 | Bulgaria |
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