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

NCT04143373 | Completed Results

• 1 other identifier: TehranUMS thesis #6234
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Blood Loss; Third Molar

Keywords

Warm Saline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of the Surgery in Minutes

  Intraoperatively, up to 30 minutes

Study Arms (2)

Warm saline

EXPERIMENTAL

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

Room temperature saline

NO INTERVENTION

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

Interventions

warm saline irrigation PROCEDURE

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.

Warm saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

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

Tehran, Iran

Location

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Results Point of Contact

• Title: Dr. Nariman Nikparto
• Organization: Tehran UMS

n-nikparto@razi.tums.ac.ir

+989124969058

Study Officials

• Mahboobe Hasheminasab, DMD

  School of dentistry, Tehran University of Medical Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 29, 2019
• Study Start: October 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 10, 2017
• Last Updated: May 7, 2020
• Results First Posted: May 7, 2020

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)