Effect of Cryotherapy on Postoperative Pain

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03716635
• Other study ID #: CEBD-CU-2018-10-19
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: November 2019

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: magy E elaskary
• Phone: 01001467262
• Email: magiessam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

Description:

the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age between 20-40 years old.

• Systemically healthy patient (ASA I or II).

• mandibular first molar teeth with:

• Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

• Ability for isolation with rubberdam.

• Restorable teeth

• Ability to fill the root canals in single visit treatment.

Exclusion Criteria:

• Teeth without good apical constriction, such as wide or open apex

• Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.

• Patients having significant systemic disorder (ASA III or IV).

• Teeth that have :

Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability

Related Conditions & MeSH terms

• Pain, Postoperative
• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Procedure:
• cryotherapy
2.5c cold saline is used as a final flush after chemomechanical preparation
• normal saline
a room temperature saline is used as a final flush after mechanical preparation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain assessed by NRS	Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain"; 1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"	up to 48 hrs postoperative pain
Secondary	amount of analgesics assessed by counting	number of analgesics tablets up to 48 hrs postoperatively	up to 48 hrs postoperatively