Effect of Intracanal Cryotherapy on Postoperative Endodontic Pain
Effect of Intracanal Cryotherapy on Endodontic Postoperative Pain in Teeth With Asymptomatic Irreversible Pulpitis and Asymptomatic Apical Periodontitis: A Four-Arm Randomized Controlled Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Centre
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Rize, Centre, Turcja (Türkiye)
- Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Systemically healthy patients with 18-70 years of age
- Single-rooted teeth with a single root canal, diagnosed with either AIP and normal periapical tissues or AAP.
Pulpal and periapical diagnoses were established according to the American Association of Endodontists (AAE) [20] diagnostic terminology. Included teeth were categorized into 2 diagnostic groups: AIP with normal periapical tissues and AAP associated with pulp necrosis. AIP was provisionally diagnosed in teeth with extremely deep caries approximating or reaching the pulp, a positive response to cold testing (Dispodent, Nadu, India), and no clinical symptoms. Periapical radiographs showed a PAI score of 1 without periodontal ligament widening. The diagnosis was confirmed intraoperatively by persistent pulpal bleeding that remained uncontrolled after 10 minutes of application of a sterile cotton pellet moistened with 2.5% sodium hypochlorite. AAP was diagnosed in teeth with a PAI score of ≥3 in the absence of clinical symptoms. None of the included teeth exhibited tenderness to percussion. All periapical radiographs were obtained using a phosphor storage plate system and the paralleling technique (Myray parallel holder, NDental, Imola, Italy) under standardized exposure parameters (70 kV, 8 mA, 0.360 s).
Exclusion Criteria: 1) Teeth with canal calcification, complex or atypical canal anatomy, root resorption, incomplete root development, or a history of endodontic treatment of the study tooth.
2) Teeth initially diagnosed with AIP in which pulpal bleeding was controlled within 10 min after access cavity preparation, as these teeth were considered eligible for vital pulp therapy.
3) Teeth initially diagnosed with AIP in which pulp necrosis was identified after access cavity preparation.
4) Teeth in which root canal treatment could not be completed in a single visit.
5) Patients who had taken analgesics within 12 hours before the appointment or antibiotics within the previous month.
6) Teeth with periodontal probing depths >3 mm or clinical/radiographic signs of periodontal disease.
7) Teeth with insufficient coronal tooth structure to allow an adequate ferrule.
8) Pregnant or breastfeeding patients and patients with systemic conditions or regular medication use that could affect treatment outcomes.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Inny: GROUP 1- Asymptomatic irreversible pulpitis - control
20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C.
Final irrigation in Groups 1 was performed using this solution.
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All endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience.
Only 1 tooth per patient was included.
Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine.
After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically.
Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy.
Apical patency was maintained 1 mm beyond the working length using a size 10 K-file.
Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle.
NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal.
Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute.
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Eksperymentalny: GROUP 2- Asymptomatic irreversible pulpitis- cryotherapy
For Group 2, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator.
The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use.
A digital thermometer was used to verify that the solution remained at 2 °C.
Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds.
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All endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience.
Only 1 tooth per patient was included.
Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine.
After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically.
Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy.
Apical patency was maintained 1 mm beyond the working length using a size 10 K-file.
Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle.
NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal.
Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute.
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Inny: GROUP 3- Asymptomatic apical periodontitis - control (n=33)
20 mL of 2.5% NaOCl was kept in a glass beaker at room temperature and monitored with a digital thermometer to maintain a temperature of 22°C.
Final irrigation in Groups 1 and 3 was performed using this solution.
|
All endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience.
Only 1 tooth per patient was included.
Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine.
After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically.
Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy.
Apical patency was maintained 1 mm beyond the working length using a size 10 K-file.
Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle.
NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal.
Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute.
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Eksperymentalny: GROUP 4- Asymptomatic apical periodontitis - cryotherapy
For Group 4, 20 mL of 2.5% NaOCl was divided into eight 2.5-mL syringes and cooled to 2 °C in a refrigerator.
The syringes were then placed in an insulated container filled with ice to maintain the target temperature during transport to the clinic and until use.
A digital thermometer was used to verify that the solution remained at 2 °C.
Each syringe was removed individually immediately before irrigation and delivered over approximately 40 seconds.
|
All endodontic procedures were completed in a single visit by one operator with 6 years of clinical experience.
Only 1 tooth per patient was included.
Local anesthesia was administered using 2 mL articaine HCl containing 1:100,000 epinephrine.
After rubber dam isolation and access cavity preparation, working length was determined using an electronic apex locator and confirmed radiographically.
Root canals were prepared with Endoart Smart Gold files to size 40/.04 and, when needed, up to 2 larger sizes according to canal anatomy.
Apical patency was maintained 1 mm beyond the working length using a size 10 K-file.
Between instruments, canals were irrigated with 2 mL of 2.5% NaOCl using a 30-gauge side-vented needle.
NaOCl was ultrasonically activated three times for 20 seconds to aid smear-layer removal.
Canals were then irrigated with saline, followed by 5 mL of 17% EDTA for 1 minute.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time
Ramy czasowe: During the first week after treatment
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During the first week after treatment
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Współpracownicy i badacze
Sponsor
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 12 (Israel lung Association)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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