The Influence of Anatomical Characteristics and Orthodontic Force on Pulpal Oxygen Saturation: A Clinical Study Using Cone-Beam Computed Tomography (CBCT)
NCT07630818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-07-16
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
Interventions
- 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.
Sponsors & Collaborators
-
Can Tho University of Medicine and Pharmacy
lead OTHER
Principal Investigators
-
Lam Nguyen Le, Assoc. Prof. · Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 15 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-01
Countries
- Vietnam
Study Locations
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