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

NCT07630818 | Completed

• 1 other identifier: Prof. Le Nguyen Lam
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic

Keywords

SpO2; Orthodontic force; pulp vitality monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Alveolar Bone and Root Anatomical Measurements on CBCT

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

Study Arms (2)

Orthodontic Force Application

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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.

Orthodontic Force Application

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, 900000, Vietnam

Location

Study Officials

• Lam Nguyen Le, Assoc. Prof.

  Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: May 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-06

Locations

VN (1)