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

Primary Purpose

Surgical Blood Loss, Third Molar

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
warm saline irrigation
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgical Blood Loss focused on measuring Warm Saline

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Warm saline

Room temperature saline

Arm Description

this site was irrigated during impacted mandibular third molar surgery, with normal saline of 37 ± 1 ° C as for the experimental side.

this site was irrigated during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C as for the control side.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2019
Last Updated
April 25, 2020
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04143373
Brief Title
Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Blood Loss, Third Molar
Keywords
Warm Saline

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warm saline
Arm Type
Experimental
Arm Description
this site was irrigated during impacted mandibular third molar surgery, with normal saline of 37 ± 1 ° C as for the experimental side.
Arm Title
Room temperature saline
Arm Type
No Intervention
Arm Description
this site was irrigated during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C as for the control side.
Intervention Type
Procedure
Intervention Name(s)
warm saline irrigation
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahboobe Hasheminasab, DMD
Organizational Affiliation
School of dentistry, Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
department of oral and maxillofacial surgery, school of dentistry, Tehran university of medical sciences,
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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