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

Last updated: July 8, 2021
Sponsor: Plovdiv Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT04967456
MedicalUniversity_Doppler
  • Ages < 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fit and healthy subjects aged < 18-year-old;
  2. Subjects with maxillary permanent incisor subjected to a traumatic injury without anydentoalveolar trauma involvement and have a contralateral homologous tooth with nosigns/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 acontrol tooth;
  6. Ability to obtain a verbal acceptance from all the subjects to comply with all thetreatments and follow-up timepoints attendance;
  7. Ability to obtain written informed consent by the patients' parents/guardians fortreatment, participation in the study and publication

Exclusion

Exclusion Criteria:

  1. Subjects who were undergoing therapy for neurological conditions or with mental orcognitive problems;
  2. Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7days 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 theinvestigated teeth.

Study Design

Total Participants: 44
Study Start date:
July 09, 2021
Estimated Completion Date:
August 31, 2022

Study 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.

Connect with a study center

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

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Medical University - Plovdiv, Bulgaria

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

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