근관치료 후 통증에 대한 냉동요법의 효과
증상이 있는 치근단 치주염 환자에서 냉동요법과 교합축소술이 근관치료 후 통증에 미치는 영향
The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars?
Participants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction.
Researchers will compare [Cryotherapy, occlusal reduction, and no intervention] to see the intensity of post-endodontic pain.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the operator and the patients will not be aware of their group/used root canal irrigant.
Group I : normal room temperature saline irrigation protocol without occlusal reduction.
Group II : normal room temperature saline irrigation protocol with occlusal reduction.
Group III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.
Procedural steps:
- Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- All the canals will be prepared using ProTaper Gold rotary files till the master apical file F2.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
- In group I the root canals will be obturated directly after preparation.
- In group II occlusal reduction will be performed after root canal preparation.
- For group III the root canals will be irrigated for 5 min using 20 ml cryo-treated saline maintained at a temperature of 2°C-4°C.
- After completion of cleaning and shaping dried using appropriate size paper points and the canals will be obturated using gutta-percha, and restored by permanent composite restoration.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, 아랍 에미리트, 4184
- Gulf Medical University
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age: 18-70 years
- A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
- require endodontic therapy
- Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
- Healthy patients without systemic disease
- Permanent mature first mandibular molars
Exclusion Criteria:
- Medically compromised patients
- Pregnant patients
- Teeth with incomplete apex formation
- Teeth with calcified canals
- Periapical abscess
- Patients on antibiotic therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
|
활성 비교기: Occlusal reduction
Normal room temperature saline irrigation protocol with occlusal reduction |
Reduction of the functional and non-functional cusps |
|
간섭 없음: Control
Normal room temperature saline irrigation protocol without occlusal reduction |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The Level of Post-endodontic Pain
기간: 6 hours
|
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be) |
6 hours
|
|
The Level of Post-endodontic Pain
기간: 24 hours
|
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be) |
24 hours
|
|
The Level of Post-endodontic Pain
기간: 48 hours
|
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be) |
48 hours
|
|
The Level of Post-endodontic Pain
기간: 72 hours
|
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be) |
72 hours
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IRB/COD/STD/14/May-2022
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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