Clinical trial NCT04967456: Efficacy of Laser Doppler Flowmetry as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth
Official title: Efficacy of Laser Doppler Flowmetry, as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Diagnosis Dual
Keywords: Laser Doppler flowmetry
pulpal blood flow
pulp vitality
traumatised teeth
paediatric dentistry
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 44
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, split-mouth, controlled, clinical trial
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in pulpal blood flow
timeFrame: 180 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
city: Plovdiv
country: Bulgaria
facility: Medical University - Plovdiv, Bulgaria
Study officials:
affiliation: Plovdiv Medical University
name: Maria Shindova, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.