Clinical trial NCT03716635: Effect of Cryotherapy on Postoperative Pain
Official title: Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Symptomatic Irreversible Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A random sequence will be generated by computer software, (http://www.random.org/).

The table will be kept with the assistant supervisor.
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: postoperative pain assessed by NRS
timeFrame: up to 48 hrs postoperative pain
Secondary outcomes:
measure: amount of analgesics assessed by counting
timeFrame: up to 48 hrs postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: 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.