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

NCT06082479 | Completed

• 1 other identifier: 304
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Inflammation

Keywords

Cryotherapy; substance P; apical periodontitis; post operative pain

Outcome Measures

Primary Outcomes (1)

• Level of post operative pain using 10 cm visual analoge scale (VAS)

  On 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.

  after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit

Secondary Outcomes (1)

• Level of inflammatory mediator substance P in apical fluid

  base line: immediately after procedure.the second is 30 minutes later in both groups.

Study Arms (2)

control group

NO INTERVENTION

no application of any type of cryotherapy.

cryotherapy group

ACTIVE COMPARATOR

after the completion of the mechanical preparation. A 2.5 x5 centimetre gel pack was placed in the mouth on the vestibular surface of the treated tooth.

Procedure: intraoral cryotherapy,ice gel

Interventions

intraoral cryotherapy,ice gel PROCEDURE

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).

Also known as: cold therapy,ice pack

cryotherapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (2)

• 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

• 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.

  PMID: 37222468 BACKGROUND

Related Links

• worked on inflammatory mediators in similar matter

MeSH Terms

Conditions

Pain, Postoperative; Inflammation; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Maram F Obeid, Professor

  Faculty of Dentistry,Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Endodontics

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

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 13, 2023
• Study Start: September 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 2025 ,available for a year
• Access Criteria: review the purpose of request

Locations

EG (1)