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
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Centre
-
Rize, Centre, Turecko (Türkiye)
- Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: 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.
|
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.
|
|
Experimentální: 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.
|
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.
|
|
Jiný: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time
Časové okno: During the first week after treatment
|
During the first week after treatment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12 (Israel lung Association)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na root canal treatment and cryotherapy
-
KLOX Technologies Inc.DokončenoStředně těžká až těžká chronická parodontitidaKanada
-
University of North Carolina, Chapel HillDokončeno
-
Ohio State UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... a další spolupracovníciNáborTýrání dětí | Porucha užívání látek (SUD) | Zdraví na venkově | Substance Use Recovery | Rodinná odolnost | Dětská pohodaSpojené státy
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)DokončenoProblém s chováním dítěte | Mateřská depreseSpojené státy
-
West Virginia UniversityBausch Health Americas, Inc.Aktivní, ne náborParadentózaSpojené státy
-
Yuzuncu Yıl UniversityDokončenoAgresivní parodontitida
-
Inonu UniversityDokončenoMrtvice | Snímky motoru | Výcvik pozorování akcí | Odstupňované snímky motoruTurecko (Türkiye)
-
University of Alabama at BirminghamJohns Hopkins University; Birmingham AIDS Outreach; AIDS UnitedDokončenoHIV infekce | Ztráta péče o HIV k následnému sledování
-
University of MessinaDokončenoChronická parodontitida
-
Faith Summersett WilliamsZatím nenabíráme