Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Experimental | Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
|
| Occlusal reduction | Active Comparator | Normal room temperature saline irrigation protocol with occlusal reduction |
|
| Control | No Intervention | Normal room temperature saline irrigation protocol without occlusal reduction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Procedure | Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 hours |
| 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) | 24 hours |
| 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) | 48 hours |
| 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) | 72 hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gulf Medical University | Ajman | 4184 | United Arab Emirates |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cryotherapy | Final irrigation with cold saline (2.5C-4C) without occlusal reduction Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
| FG001 | Occlusal Reduction | Normal room temperature saline irrigation protocol with occlusal reduction Occlusal reduction: Reduction of the functional and non-functional cusps |
| FG002 | Control | Normal room temperature saline irrigation protocol without occlusal reduction |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cryotherapy | Final irrigation with cold saline (2.5C-4C) without occlusal reduction Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
| BG001 | Occlusal Reduction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 6 hours |
|
at 3 month, 6 month, and 1 year.
Overall number of participants, in each arm/group, who died due to any cause.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cryotherapy | Final irrigation with cold saline (2.5C-4C) without occlusal reduction Cryotherapy: Final irrigation with cold saline (2.5C-4C) without occlusal reduction |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rania Zaarour | Gulf Medical University | +971 6 7431333 | 4184 | dr.rania@gmu.ac.ae |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Nov 13, 2024 | Nov 13, 2024 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 13, 2024 | Nov 13, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Occlusal reduction | Procedure | Reduction of the functional and non-functional cusps |
|
Normal room temperature saline irrigation protocol with occlusal reduction
Occlusal reduction: Reduction of the functional and non-functional cusps
| BG002 | Control | Normal room temperature saline irrigation protocol without occlusal reduction |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Saline | 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) |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 24 hours |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | 48 hours |
|
|
|
|
| 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) | Posted | Mean | Standard Error | score on a scale | 72 hours |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Occlusal Reduction | Normal room temperature saline irrigation protocol with occlusal reduction Occlusal reduction: Reduction of the functional and non-functional cusps | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Saline | Normal room temperature saline irrigation protocol without occlusal reduction | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided