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The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.
The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. For this purpose, 40 mandibular impacted third molars will be randomly allocated to two groups and surgically removed with the abovementioned saline temperatures. Finally, the suctioned liquids and duration of the surgeries will be carefully measured and compared between both sides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warm saline | Experimental | this site was irrigated during impacted mandibular third molar surgery, with normal saline of 37 ± 1 ° C as for the experimental side. |
|
| Room temperature saline | No Intervention | this site was irrigated during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C as for the control side. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| warm saline irrigation | Procedure | The objective of this research was to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Bleeding in Cubic Centimetre | both sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared | Intraoperatively, up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the Surgery in Minutes | both sides will be irrigated with 200cc of saline and the duration of the surgeries will be carefully measured and compared between both sides | Intraoperatively, up to 30 minutes |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mahboobe Hasheminasab, DMD | School of dentistry, Tehran University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of oral and maxillofacial surgery, school of dentistry, Tehran university of medical sciences, | Tehran | Iran |
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In this study, the Enrollment number not equal to the number of participants who Started because this was a split-person design study in which 20 participants enrolled and within each individual, the left or right sides were allocated randomly for receiving these two types of saline.
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| ID | Title | Description |
|---|---|---|
| FG000 | Room Temperature Saline of 25 ± 2 ° C | In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side. Within each individual, the left or right sides were allocated randomly for receiving these two types of saline. |
| FG001 | Warm Saline of 37 ± 1 ° C | In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side. Within each individual, the left or right sides were allocated randomly for receiving these two types of saline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | In this study, during impacted mandibular third molar surgery, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side was irrigated with normal saline of 37 ± 1 ° C as for the experimental side. The side for each intervention was determined by a table of random numbers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Amount of Bleeding in Cubic Centimetre | both sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared | Posted | Mean | Standard Deviation | Cubic Centimeter | Intraoperatively, up to 30 minutes | third molar teeth | third molar teeth |
|
4 weeks
Since this surgical procedure is considered as minor oral surgery, and all participants were included only if they had no systemic condition, the number of participants at risk for Serious Adverse Events and All-Cause Mortality is considered as zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | In this study, during impacted mandibular third molar surgery, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side was irrigated with normal saline of 37 ± 1 ° C as for the experimental side. The side for each intervention was determined by a table of random numbers. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nariman Nikparto | Tehran UMS | +989124969058 | n-nikparto@razi.tums.ac.ir |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2019 | Nov 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| third molar teeth |
|
| years |
| Participants |
|
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| Sex: Female, Male | Count of Participants | Participants | Participants |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
In this study, during impacted mandibular third molar surgery, within each individual, one side was irrigated with room temperature saline of 25 ± 2 ° C as for the control side, while the other side of the same individual, was irrigated with normal saline of 37 ± 1 ° C as for the experimental side. Within each individual, the left or right sides were allocated randomly for receiving these two types of saline. |
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| Secondary | Duration of the Surgery in Minutes | both sides will be irrigated with 200cc of saline and the duration of the surgeries will be carefully measured and compared between both sides | Posted | Mean | Standard Deviation | minutes | Intraoperatively, up to 30 minutes | third molar teeth | third molar teeth |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 20 |
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