Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-09-12
2023-12-12
Brief Summary
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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.
Detailed Description
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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:
1. 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.
2. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
3. 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.
4. 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.
5. Hand instrumentation to 15-size K files.
6. All the canals will be prepared using ProTaper Gold rotary files till the master apical file F2.
7. Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
8. All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
9. In group I the root canals will be obturated directly after preparation.
10. In group II occlusal reduction will be performed after root canal preparation.
11. 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.
12. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Occlusal reduction
Normal room temperature saline irrigation protocol with occlusal reduction
Occlusal reduction
Reduction of the functional and non-functional cusps
Control
Normal room temperature saline irrigation protocol without occlusal reduction
No interventions assigned to this group
Interventions
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Cryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Occlusal reduction
Reduction of the functional and non-functional cusps
Eligibility Criteria
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Inclusion Criteria
2. A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
3. require endodontic therapy
4. Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
5. Healthy patients without systemic disease
6. Permanent mature first mandibular molars
Exclusion Criteria
2. Pregnant patients
3. Teeth with incomplete apex formation
4. Teeth with calcified canals
5. Periapical abscess
6. Patients on antibiotic therapy
18 Years
70 Years
ALL
Yes
Sponsors
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Gulf Medical University
OTHER
Responsible Party
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Rania Zaarour
Assistant Professor of Cell Biology and Researcher
Locations
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Gulf Medical University
Ajman, , United Arab Emirates
Countries
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Other Identifiers
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IRB/COD/STD/14/May-2022
Identifier Type: -
Identifier Source: org_study_id