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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Blood Loss; Third Molar
• Intervention / Treatment: Procedure: warm saline irrigation

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • department of oral and maxillofacial surgery, school of dentistry, Tehran university of medical sciences,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 10, 2017

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: April 25, 2020
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Warm Saline
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: TehranUMS thesis #6234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No