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: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical protocol is to evaluate and compare the physiological responses of dental pulp to two different magnitudes of orthodontic force during active orthodontic treatment. Participants are assigned to either a 150g orthodontic force group (experimental group) or a 50g orthodontic force group (active comparator group). Orthodontic Force Application: A continuous orthodontic force of approximately 150g is applied to the target teeth in the experimental group, whereas a continuous force of approximately 50g is applied to the target teeth in the active comparator group. The magnitude of the applied force is verified using a tension gauge to ensure standardized force delivery. Pulse Oximetry (SpO₂) Measurement: Pulp oxygen saturation (SpO₂) is assessed using the same standardized protocol in both groups. The target teeth are isolated with cotton rolls to control moisture, and the dental chair light is turned off to minimize optical interference with the pulse oximeter. Three consecutive measurements are obtained at each assessment time point, and the mean value is recorded for analysis. This standardized protocol enables comparison of pulp oxygen saturation responses between teeth subjected to 150g and 50g orthodontic forces while minimizing variability related to force application and measurement procedures.

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)

150g Orthodontic Force Group

EXPERIMENTAL

Participants in this group receive a controlled orthodontic force of approximately 150 g applied to the target teeth. The applied force is verified using a tension gauge. Pulp oxygen saturation (SpO₂) is assessed at predefined time points. At each assessment, three consecutive measurements are obtained under moisture isolation with the dental chair light turned off to minimize optical interference, and the mean SpO₂ value is recorded.

Device: 150g Orthodontic Force Application

50g Orthodontic Force Group

ACTIVE COMPARATOR

Participants in this group receive a controlled orthodontic force of approximately 50 g applied to the target teeth. The applied force is verified using a tension gauge. Pulp oxygen saturation (SpO₂) is assessed at the same predefined time points and using the same standardized measurement protocol as in the 150-g group. Three consecutive measurements are obtained at each assessment, and the mean SpO₂ value is recorded.

Device: 50g Orthodontic Force Application

Interventions

150g Orthodontic Force Application DEVICE

A controlled mechanical orthodontic force of approximately 150g is applied to the target teeth and verified using a tension gauge. The force is applied to induce orthodontic tooth movement, and pulp oxygen saturation (SpO₂) is monitored at predefined follow-up time points.

150g Orthodontic Force Group

50g Orthodontic Force Application DEVICE

A controlled mechanical orthodontic force of approximately 50g is applied to the target teeth and verified using a tension gauge. The force serves as the active comparator, and pulp oxygen saturation (SpO₂) is monitored at the same predefined follow-up time points as in the 150g group.

50g Orthodontic Force Group

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: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

VN (1)