Clinical trial NCT06082479: The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis
Official title: The Effect of Cryotherapy on Pain and Substancs P Level in Patients With Symptomatic Apical Periodontitis (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Inflammation
Keywords: Cryotherapy
substance P
apical periodontitis
post operative pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.
Primary purpose: TREATMENT

Brief summary: The participants were divided into two groups: Group I (cryotherapy) (n =10) after the completion of the mechanical preparation intra oral cryotherapy was applied. Group II (control) (n =10) received standard root canal treatment without the application of any type of cryotherapy.

Detailed description: 1-Patients selection: 20 patients with symptomatic apical peridontitis related to mandibular premolars were selected . After proper anestehsia, Access cavity preparation was performed. The working length measured using apex locator. chemicomechanical preparation was done. for cryotherapy group: cold pack (ice gel enveloped by a sealed plastic cover) measuring 2.5 x 5 centimetres was placed intraorally on the vestibular surface of the treated tooth for a total time of 30 minutes. apical fluid sample was collected by paper point and the root canal was then filled using gutta percha and resin-based sealer.The access cavity was sealed using glass ionomer restoration. for the control group normal treatment was done and apical fluid was collested also before obturation.

Eligibility criteria: Inclusion criteria:

* clinical diagnosis of symptomatic apical periodontitis related to ving a mandibular single-rooted premolars
* radigraphically: absence of periapical radiolucency on x ray.

Exclusion criteria:

* The presence of any systemic disease or allergic reactions
* Vulnerable population: prisoners, pregnant women, mentally ill people, etc.
* Use of analgesic or antibiotic medication within three days
* A radiographically untraceable canal

Primary outcomes:
measure: Level of post operative pain using 10 cm visual analoge scale (VAS)
timeFrame: after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit
Secondary outcomes:
measure: Level of inflammatory mediator substance P in apical fluid
timeFrame: base line: immediately after procedure.the second is 30 minutes later in both groups.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Faculty of Dentistry,Ain Shams University
name: Maram F Obeid, Professor
role: STUDY_DIRECTOR
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.
citation: Keskin C, Aksoy A, Kalyoncuoglu E, Keles A, Ilik AA, Komec O, Yuzgulec E, Akgun H, Alak SG, Tokur O. Effect of intracanal cryotherapy on the inflammatory cytokine, proteolytic enzyme levels and post-operative pain in teeth with asymptomatic apical periodontitis: A randomized clinical trial. Int Endod J. 2023 Aug;56(8):932-942. doi: 10.1111/iej.13937. Epub 2023 May 30.