The Influence of Anatomical Characteristics and Orthodontic Force on Pulpal Oxygen Saturation: A Clinical Study Using Cone-Beam Computed Tomography (CBCT)
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Can Tho, Wietnam, 900000
- Can Tho University of Medicine and Pharmacy
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 150g Orthodontic Force Group
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.
|
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.
|
|
Aktywny komparator: 50g Orthodontic Force Group
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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Changes in Dental Pulp Oxygen Saturation (SpO2) Levels
Ramy czasowe: 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.
|
Baseline (pre-force), 20 minutes, 24 hours, 7 days, and 4 weeks post-force application
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Alveolar Bone and Root Anatomical Measurements on CBCT
Ramy czasowe: Baseline (at the time of the pre-existing CBCT scan prior to the canine retraction phase)
|
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.
|
Baseline (at the time of the pre-existing CBCT scan prior to the canine retraction phase)
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Lam Nguyen Le, Assoc. Prof., Faculty of Odonto-Stomatology, Can Tho University of Medicine and Pharmacy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Prof. Le Nguyen Lam
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .