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The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis

The Effect of Cryotherapy on Pain and Substancs P Level in Patients With Symptomatic Apical Periodontitis (A Randomized Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06082479
Enrollment
20
Registered
2023-10-13
Start date
2022-09-01
Completion date
2023-02-01
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Post Operative Pain

Keywords

Cryotherapy, substance P, apical periodontitis, post operative pain

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.

Interventions

PROCEDUREintraoral cryotherapy,ice gel

A 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. Each cold pack was kept for ten minutes.3 packs were used for each patient, for a total time of 30 minutes.Patients were instructed to remove the cold pack for 1-2 minutes if they felt extreme cold or a burning sensation .The temperature of the gel was checked by a digital thermometer (Brannan, UK) after it was removed from the freezer and kept in an ice box (Cosmoplast, UAE) containing a cooling gel (Exam Packaging, Belgium).

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

A) Sequence generation;was done using a random sequence number generated by computer software. B) Allocation Concealment Mechanism: Folded, numbered papers were placed in tightly sealed envelopes containing the patient's coding

Intervention model description

This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Level of post operative pain using 10 cm visual analoge scale (VAS)after 6hours, 24hours, 48hours, 72hours h, and 7days after the visitOn a10-cm Visual Analogue Scale (VAS) questionnaire, each patient reported their level of pain as follows: There is no pain at 0, 1-3, mild, 4-6, moderate, 7-9, severe, and 10, the worst pain.

Secondary

MeasureTime frameDescription
Level of inflammatory mediator substance P in apical fluidbase line: immediately after procedure.the second is 30 minutes later in both groups.Apical fluid samples were obtained using paper points size 25 passing 2 mm beyond the apex.where they were soaked by the periapical interstitial fluid for 1 minute .Four mm from the tip of each paper point was cut and dropped into 1.5-mL Eppendorf tubes (Swanscombe, UK) with 1 mL (pH 7.4) phosphate buffered saline, then stored at -80°C. Levels of substance p were measured using the ELISAtest.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026