- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07710833
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
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Centre
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Rize, Centre, 터키 (Türkiye)
- Recep Tayyip Erdoğan University Faculty of Dentistry, Department of Endodontics
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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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실험적: 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.
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|
다른: 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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|
실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Between- and Within-Group Comparisons of Postoperative Pain Scores Over Time
기간: During the first week after treatment
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During the first week after treatment
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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치근단 치주염에 대한 임상 시험
root canal treatment and cryotherapy에 대한 임상 시험
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus모병