Trial Outcomes & Findings for Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery (NCT NCT04143373)
NCT ID: NCT04143373
Last Updated: 2020-05-07
Results Overview
both sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Intraoperatively, up to 30 minutes
Results posted on
2020-05-07
Participant Flow
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.
Unit of analysis: third molar teeth
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20 20
|
20 20
|
|
Overall Study
COMPLETED
|
20 20
|
20 20
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery
Baseline characteristics by cohort
| Measure |
All Study Participants
n=40 third molar teeth
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.
|
|---|---|
|
Age, Continuous
|
26.40 years
STANDARD_DEVIATION 5.384 • n=20 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Intraoperatively, up to 30 minutesboth sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared
Outcome measures
| Measure |
Room Temperature Saline of 25 ± 2 ° C
n=20 third molar teeth
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.
|
Warm Saline of 37 ± 1 ° C
n=20 third molar teeth
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.
|
|---|---|---|
|
Amount of Bleeding in Cubic Centimetre
|
11.95 Cubic Centimeter
Standard Deviation 2.762
|
8.75 Cubic Centimeter
Standard Deviation 2.593
|
SECONDARY outcome
Timeframe: Intraoperatively, up to 30 minutesboth sides will be irrigated with 200cc of saline and the duration of the surgeries will be carefully measured and compared between both sides
Outcome measures
| Measure |
Room Temperature Saline of 25 ± 2 ° C
n=20 third molar teeth
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.
|
Warm Saline of 37 ± 1 ° C
n=20 third molar teeth
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.
|
|---|---|---|
|
Duration of the Surgery in Minutes
|
14.65 minutes
Standard Deviation 1.954
|
14.65 minutes
Standard Deviation 1.725
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place