Cryotherapy
Conditions
Keywords
Post endodontic pain, Cryotherapy, Occlusal reduction, Root canal treatment
Brief summary
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.
Detailed description
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: 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.
Interventions
PROCEDURECryotherapy
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
PROCEDUREOcclusal reduction
Reduction of the functional and non-functional cusps
Sponsors
Gulf Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 18-70 years 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
1. Medically compromised patients 2. Pregnant patients 3. Teeth with incomplete apex formation 4. Teeth with calcified canals 5. Periapical abscess 6. Patients on antibiotic therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Level of Post-endodontic Pain | 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) |
Countries
United Arab Emirates
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cryotherapy Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction | 20 |
| Occlusal Reduction Normal room temperature saline irrigation protocol with occlusal reduction
Occlusal reduction: Reduction of the functional and non-functional cusps | 20 |
| Control Normal room temperature saline irrigation protocol without occlusal reduction | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Cryotherapy | Occlusal Reduction | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 7.85 | 31.4 years STANDARD_DEVIATION 6.56 | 32.35 years STANDARD_DEVIATION 8.98 | 32.5 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Region of Enrollment United Arab Emirates | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Female | 11 Participants | 17 Participants | 12 Participants | 40 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 8 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
The Level of Post-endodontic Pain
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)
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryotherapy | The Level of Post-endodontic Pain | 1.85 score on a scale | Standard Deviation 1.81 |
| Occlusal Reduction | The Level of Post-endodontic Pain | 2.15 score on a scale | Standard Deviation 2.11 |
| Saline | The Level of Post-endodontic Pain | 3.65 score on a scale | Standard Deviation 3.03 |
p-value: 0.986Kruskal-Wallis
Primary
The Level of Post-endodontic Pain
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)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryotherapy | The Level of Post-endodontic Pain | 0.70 score on a scale | Standard Deviation 1.13 |
| Occlusal Reduction | The Level of Post-endodontic Pain | 1.2 score on a scale | Standard Deviation 1.32 |
| Saline | The Level of Post-endodontic Pain | 2.2 score on a scale | Standard Deviation 1.82 |
p-value: <0.118Kruskal-Wallis
Primary
The Level of Post-endodontic Pain
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)
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryotherapy | The Level of Post-endodontic Pain | 0.25 score on a scale | Standard Deviation 0.79 |
| Occlusal Reduction | The Level of Post-endodontic Pain | 1.2 score on a scale | Standard Deviation 1.32 |
| Saline | The Level of Post-endodontic Pain | 2.2 score on a scale | Standard Deviation 1.82 |
p-value: 0.225Kruskal-Wallis
Primary
The Level of Post-endodontic Pain
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)
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cryotherapy | The Level of Post-endodontic Pain | 0.10 score on a scale | Standard Error 0.45 |
| Occlusal Reduction | The Level of Post-endodontic Pain | 0.05 score on a scale | Standard Error 0.22 |
| Saline | The Level of Post-endodontic Pain | 0.25 score on a scale | Standard Error 0.72 |
p-value: 0.424Kruskal-Wallis