Effect of Cryotherapy on Postoperative Pain

NCT03716635 | Unknown

• 1 other identifier: CEBD-CU-2018-10-19
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• amount of analgesics assessed by counting

  up to 48 hrs postoperatively

Study Arms (2)

cryotherapy

EXPERIMENTAL

2.5c cold saline as a final flush after chemicomechanical debridement

Procedure: cryotherapy

normal saline

OTHER

room temperature saline is used as a final flush after chemicomechanical preparation

Procedure: normal saline

Interventions

cryotherapy PROCEDURE

2.5c cold saline is used as a final flush after chemomechanical preparation

cryotherapy

normal saline PROCEDURE

a room temperature saline is used as a final flush after mechanical preparation

normal saline

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related 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.

  PMID: 29398090 BACKGROUND

MeSH Terms

Interventions

Cryotherapy; Saline Solution

Intervention Hierarchy (Ancestors)

Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

magy E elaskary

CONTACT

01001467262; magiessam@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: After determining the eligibility of the patient, the assistant supervisor will be contacted to assign the participant to either the intervention (cryotherapy) or the control (normal saline) groups according to the random sequence generated.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at endodontic department cairo university

Model Details: A random sequence will be generated by computer software, (http://www.random.org/). The table will be kept with the assistant supervisor.

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share