OrthodonticNCT07630818
The Influence of Anatomical Characteristics and Orthodontic Force on Pulpal Oxygen Saturation: A Clinical Study Using Cone-Beam Computed Tomography (CBCT)
A study testing 150g Orthodontic Force Application and 50g Orthodontic Force Application in people with Orthodontic, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic
- What is being tested?
- 150g Orthodontic Force Application and 50g Orthodontic Force Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteVietnam
- Study dates
- 1 May 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- 150g Orthodontic Force Application, 50g Orthodontic Force Application
- Keywords
- SpO2, Orthodontic force, pulp vitality monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150g Orthodontic Force ApplicationDevice
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.
50g Orthodontic Force ApplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 50g Orthodontic Force Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (at the time of the pre-existing CBCT scan prior to the canine retraction phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 May 2025
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lam Nguyen Le, Assoc. Prof., Principal investigator, Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630818
- Sponsor's protocol ID
- Prof. Le Nguyen Lam
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Anatomical Characteristics and Orthodontic Force on Pulpal Oxygen Saturation: A Clinical Study Using Cone-Beam Computed Tomography (CBCT)
- ClinicalTrials.gov ID
- NCT07630818
- Acronym / sponsor ID
- Prof. Le Nguyen Lam
- Conditions
- Orthodontic
- Keywords
- SpO2, Orthodontic force, pulp vitality monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150g Orthodontic Force Group | Experimental | Device: 150g Orthodontic Force ApplicationParticipants 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. |
| 50g Orthodontic Force Group | Active comparator | Device: 50g Orthodontic Force ApplicationParticipants 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. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150g Orthodontic Force ApplicationA 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. | Device | 150g Orthodontic Force Group |
| 50g Orthodontic Force ApplicationA 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. | Device | 50g Orthodontic Force Group |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lam Nguyen Le, Assoc. Prof. principal investigator
Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 150g Orthodontic Force Application and 50g Orthodontic Force Application in people with Orthodontic, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.