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

• Sponsor: Tehran University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04143373
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 8.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Blood Loss; Third Molar	Procedure: warm saline irrigation	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Warm saline this site was irrigated during impacted mandibular third molar surgery, with normal saline of 37 ± 1 ° C as for the experimental side.	Procedure: warm saline irrigation; 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.
No Intervention: Room temperature saline this site was irrigated during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C as for the control side.

Outcome Measures

Primary Outcome Measures

1. Amount of Bleeding in Cubic Centimetre [Intraoperatively, up to 30 minutes]

   both sides will be irrigated with 200cc of saline and the suctioned liquids will be carefully measured and compared

Secondary Outcome Measures

1. Duration of the Surgery in Minutes [Intraoperatively, up to 30 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	department of oral and maxillofacial surgery, school of dentistry, Tehran university of medical sciences,	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Tehran University of Medical Sciences

Investigators

• Study Director: Mahboobe Hasheminasab, DMD, School of dentistry, Tehran University of Medical Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 1, 2019

More Information

Publications

None provided.

• Responsible Party: Tehran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04143373
• Other Study ID Numbers: TehranUMS thesis #6234
• First Posted: Oct 29, 2019
• Last Update Posted: May 7, 2020
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tehran University of Medical Sciences: Warm Saline
• Additional relevant MeSH terms: Blood Loss, Surgical

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Room Temperature Saline of 25 ± 2 ° C	Warm Saline of 37 ± 1 ° C
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	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.
Overall Participants	20
Overall third molar teeth	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.40 (5.384)
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Amount of Bleeding in Cubic Centimetre
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Temperature Saline of 25 ± 2 ° C	Warm Saline of 37 ± 1 ° C
Arm/Group Description	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.	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.
Measure Participants	20	20
Measure third molar teeth	20	20
Mean (Standard Deviation) [Cubic Centimeter]	11.95 (2.762)	8.75 (2.593)

2. Secondary Outcome

Title	Duration of the Surgery in Minutes
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Room Temperature Saline of 25 ± 2 ° C	Warm Saline of 37 ± 1 ° C
Arm/Group Description	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.	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.
Measure Participants	20	20
Measure third molar teeth	20	20
Mean (Standard Deviation) [minutes]	14.65 (1.954)	14.65 (1.725)

Adverse Events

Time Frame	4 weeks
Adverse Event Reporting Description	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.
Arm/Group Title	All Study Participants
Arm/Group Description	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.
All Cause Mortality
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	All Study Participants
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.