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

June 2, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Dental Pulp Oxygen Saturation (SpO2) Levels
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar Bone and Root Anatomical Measurements on CBCT
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Can Tho University of Medicine and Pharmacy

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

June 1, 2026

Study Completion (Actual)

June 1, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Prof. Le Nguyen Lam

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Orthodontic

Clinical Trials on Orthodontic Force Application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe