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Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery

The Effect of Warm Saline Irrigation on the Amount of Bleeding in Impacted Mandibular Third Molar Surgery: a Split-mouth Single-blinded Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04143373
Enrollment
20
Registered
2019-10-29
Start date
2017-10-01
Completion date
2017-12-10
Last updated
2020-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Blood Loss, Third Molar

Keywords

Warm Saline

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Being a candidate for bilateral mandibular third molar surgery * Both mandibular third molars must have a similar inclination to the second molar * Both mandibular third molars must have same Pell & Gregory's classification

Exclusion criteria

* Presence of any systemic condition or using any type of medication * History of allergy to local anesthetic (LA) solutions * Patients with an active gag reflex * Pregnant and post-menopause women * Patients with pericoronitis or any local inflammation

Design outcomes

Primary

MeasureTime frameDescription
Amount of Bleeding in Cubic CentimetreIntraoperatively, up to 30 minutesboth sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared

Secondary

MeasureTime frameDescription
Duration of the Surgery in MinutesIntraoperatively, 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

Countries

Iran

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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.
20
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.
40
Total60

Baseline characteristics

CharacteristicAll Study Participants
Age, Continuous26.40 years
STANDARD_DEVIATION 5.384
Sex: Female, Male
Female
16 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 0

Outcome results

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

Time frame: Intraoperatively, up to 30 minutes

ArmMeasureValue (MEAN)Dispersion
Room Temperature Saline of 25 ± 2 ° CAmount of Bleeding in Cubic Centimetre11.95 Cubic CentimeterStandard Deviation 2.762
Warm Saline of 37 ± 1 ° CAmount of Bleeding in Cubic Centimetre8.75 Cubic CentimeterStandard Deviation 2.593
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

Time frame: Intraoperatively, up to 30 minutes

ArmMeasureValue (MEAN)Dispersion
Room Temperature Saline of 25 ± 2 ° CDuration of the Surgery in Minutes14.65 minutesStandard Deviation 1.954
Warm Saline of 37 ± 1 ° CDuration of the Surgery in Minutes14.65 minutesStandard Deviation 1.725

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026