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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthodontic

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Can Tho University of Medicine and Pharmacy

Can Tho, 900000, Vietnam

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthodontic Force Application

Device

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jun 5, 2026
Registry last updated: Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed