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The Influence of Anatomical Characteristics and Orthodontic Force on Pulpal Oxygen Saturation: A Clinical Study Using Cone-Beam Computed Tomography (CBCT)

2. juni 2026 opdateret af: Can Tho University of Medicine and Pharmacy
The primary objective of this clinical protocol is to evaluate the physiological responses of dental tissues during active orthodontic treatment. By focusing on standardized force application and precise pulp vitality monitoring, this study aims to ensure both treatment efficacy and patient safety. The clinical intervention is strictly divided into two systematic procedures:Orthodontic Force Application: Orthodontic force is exerted in strict compliance with the established standard treatment protocol. A continuous force of approximately 150g is applied to the target teeth and precisely calibrated using a specialized tension gauge.Pulse Oximetry (SpO2) Measurement: To guarantee optimal data accuracy, the target teeth are completely isolated using cotton rolls to manage moisture. The dental chair light is turned off during the procedure to eliminate any ambient optical interference with the sensor. Measurements are performed three times consecutively, and the arithmetic mean is calculated as the final representative value.In conclusion, this dual-step protocol provides a rigorous and reproducible framework for orthodontic research. The combination of controlled mechanical loading and standardized SpO2 monitoring minimizes external variables, thereby enhancing the reliability of the clinical outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Vietnam
      • Can Tho, Vietnam, 900000
        • Can Tho University of Medicine and Pharmacy

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Patients aged between 15 and 35 years old.
  • Patients undergoing routine fixed orthodontic treatment with indications for premolar extractions and subsequent canine retraction phase.
  • Target canines must be vital with healthy dental pulp and no periapical pathology.
  • Pre-existing Cone-Beam Computed Tomography (CBCT) scans of acceptable diagnostic quality available in the patient's records, taken prior to the canine retraction phase.
  • Patient or legal guardian provides written informed consent to participate in the study.

Exclusion Criteria:

  • Target canines with a history of dental trauma, extensive caries, periodontal disease, or previous endodontic treatment.
  • Patients with systemic diseases affecting peripheral blood circulation or microvasculature (e.g., cardiovascular diseases, severe anemia, diabetes, chronic respiratory conditions).
  • Patients currently using systemic vasoconstrictors or anti-inflammatory medications during the active monitoring period.
  • Pregnancy or lactation.
  • Refusal to sign the informed consent form.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Orthodontic Force Application
An orthodontic force of approximately 150g is applied to the target teeth and verified using a tension gauge. Pulp vitality (SpO2) is measured three times consecutively under moisture isolation (cotton rolls) and with the dental chair light turned off to prevent optical interference. The average SpO2 value is recorded
Enhed: Orthodontic Force Application
Application of a controlled mechanical orthodontic force calibrated at approximately 150g using a tension gauge. This intervention is executed during designated clinical visits to initiate tooth movement, while pulp blood flow changes are subsequently monitored.
Ingen indgriben: Control Group
Subjects in this group do not receive any active orthodontic force application. Baseline pulp vitality (SpO2) measurements are recorded using the exact same clinical protocol (moisture isolation, dental chair light turned off, and 3 consecutive readings to obtain the mean value) for comparative analysis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Dental Pulp Oxygen Saturation (SpO2) Levels
Tidsramme: Baseline (pre-force), 20 minutes, 24 hours, 7 days, and 4 weeks post-force application
Dental pulp oxygen saturation levels are measured in percentages (%) using a customized pulse oximeter probe adapted for dental use. The objective is to evaluate the physiological microcirculatory response of the canine pulp following orthodontic force application.
Baseline (pre-force), 20 minutes, 24 hours, 7 days, and 4 weeks post-force application

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alveolar Bone and Root Anatomical Measurements on CBCT
Tidsramme: Baseline (at the time of the pre-existing CBCT scan prior to the canine retraction phase)
Three-dimensional anatomical variables are measured secondarily from pre-existing Cone-Beam Computed Tomography (CBCT) scans using specialized imaging software. Variables include cortical bone thickness (mm) at the canine apex region, root apex-to-cortical plate distance (mm), and total root length (mm). These baseline metrics will be correlated with the observed SpO2 changes.
Baseline (at the time of the pre-existing CBCT scan prior to the canine retraction phase)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Can Tho University of Medicine and Pharmacy

Efterforskere

  • Ledende efterforsker: Lam Nguyen Le, Assoc. Prof., Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2025

Primær færdiggørelse (Faktiske)

1. juni 2026

Studieafslutning (Faktiske)

1. juni 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Prof. Le Nguyen Lam

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Orthodontic Force Application

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