TraumaNCT04967456
Efficacy of Laser Doppler Flowmetry as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth
A study testing Measurement of pulpal blood flow of traumatised tooth in people with Trauma and Diagnosis Dual, run by Plovdiv Medical University at 2 sites in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Diagnosis Dual
- What is being tested?
- Measurement of pulpal blood flow of traumatised tooth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesBulgaria
- Study dates
- 9 Jul 2021to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fit and healthy subjects aged < 18-year-old;
- 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;
- Subjects attended their first dental visit within 3 days of the dental trauma;
- Sensitivity value of the electric pulp test over 200 μA;
- Subjects with at least one vital and non-traumatised maxillary incisor acting as a control tooth;
- Ability to obtain a verbal acceptance from all the subjects to comply with all the treatments and follow-up timepoints attendance;
- Ability to obtain written informed consent by the patients' parents/guardians for treatment, participation in the study and publication
Who cannot join
- Subjects who were undergoing therapy for neurological conditions or with mental or cognitive problems;
- Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7 days prior to the treatment commencement;
- Subjects who have never had any first dental visit or treatment;
- Subjects with systemic diseases or physiological development delay;
- Subjects with active infectious diseases such as; influenza, scarlet fever, etc.
- Subjects with restorations covered more than half the labial surface of the investigated teeth.
Trial locations and contacts
2 sites in 1 country.
Ani Belcheva, PhD contact
Bulgaria2 sites, 2 recruiting
- Recruiting
Department of Paediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv, Bulgaria
Plovdiv, 4000
Maria P Shindova, PhD, 00359898390935, mariya.shindova@gmail.com
Ani B Belcheva, PhD, 00359889528932, abeltcheva@yahoo.com
- Recruiting
Medical University - Plovdiv, Bulgaria
Plovdiv, 4000
Maria P Shindova, PhD, 00359898390935, mariya.shindova@gmail.com
Ani B Belcheva, PhD, 00359889528932, abeltcheva@yahoo.com
About this study
Official title: Efficacy of Laser Doppler Flowmetry, as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth
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.
Read the 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.
- Conditions
- Trauma, Diagnosis Dual
- Being tested
- Measurement of pulpal blood flow of traumatised tooth
- Keywords
- Laser Doppler flowmetry, pulpal blood flow, pulp vitality, traumatised teeth, paediatric dentistry
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of pulpal blood flow of traumatised toothDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth |
| 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. Receives: Diagnostic Test: Measurement of pulpal blood flow of traumatised tooth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start9 Jul 2021
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, split-mouth, controlled, clinical trial
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Shindova, PhD, Principal investigator, Plovdiv Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967456
- Sponsor's protocol ID
- MedicalUniversity_Doppler
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34442445
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laser Doppler Flowmetry, as a Diagnostic Tool in Assessing Revascularization of Traumatised Teeth
- ClinicalTrials.gov ID
- NCT04967456
- Acronym / sponsor ID
- MedicalUniversity_Doppler
- Conditions
- Trauma, Diagnosis Dual
- Keywords
- Laser Doppler flowmetry, pulpal blood flow, pulp vitality, traumatised teeth, paediatric dentistry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized, split-mouth, controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Measurement of pulpal blood flow of traumatised tooth | Active comparator | Diagnostic Test: Measurement of pulpal blood flow of traumatised toothIn the split-mouth design, the traumatised maxillary incisor will be investigated using Laser Doppler flowmetry. |
| Measurement of pulpal blood flow of non-traumatised tooth | Other | Diagnostic Test: Measurement of pulpal blood flow of traumatised toothIn the split-mouth design, this arm - the non-traumatised maxillary incisor, contralateral tooth, will be investigated using Laser Doppler flowmetry as a control tooth. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Fit and healthy subjects aged < 18-year-old;
- 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;
- Subjects attended their first dental visit within 3 days of the dental trauma;
- Sensitivity value of the electric pulp test over 200 μA;
- Subjects with at least one vital and non-traumatised maxillary incisor acting as a control tooth;
Key exclusion criteria (6 listed)
- Subjects who were undergoing therapy for neurological conditions or with mental or cognitive problems;
- Subjects who were taking sedative, analgesic, and/or anti-inflammatory medication 7 days prior to the treatment commencement;
- Subjects who have never had any first dental visit or treatment;
- Subjects with systemic diseases or physiological development delay;
- Subjects with active infectious diseases such as; influenza, scarlet fever, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of pulpal blood flow of traumatised toothMeasurement 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) | Diagnostic test | Measurement of pulpal blood flow of non-traumatised tooth, Measurement of pulpal blood flow of traumatised tooth |
Primary outcome
Changes in pulpal blood flow
Time frame: 180 seconds
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Derived from this study: PubMed 34442445Belcheva 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.
- Individual participant dataSharing planned: No
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ani Belcheva, PhD contact
Maria Shindova, PhD principal investigator
Plovdiv Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of pulpal blood flow of traumatised tooth in people with Trauma and Diagnosis Dual, run by Plovdiv Medical University at 2 sites in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Shindova, PhD (003599898390935, mariya.shindova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pulpal blood flow (time frame: 180 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04967456, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.