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

Can Tho University of Medicine and Pharmacy35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Orthodontic

Eligibility

Sex: ALLMin age: 15 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Changes in Dental Pulp Oxygen Saturation (SpO2) Levels

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.

Time frame: Baseline (pre-force), 20 minutes, 24 hours, 7 days, and 4 weeks post-force application

Secondary Outcomes

Alveolar Bone and Root Anatomical Measurements on CBCT

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.

Time frame: Baseline (at the time of the pre-existing CBCT scan prior to the canine retraction phase)