## Protocol Section
### Identification Module
**NCT ID:** NCT06082479

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 304
#### Organization
**Class:** OTHER
**Full Name:** Ain Shams University
### Status Module
#### Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-29

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2023-10-13
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-29
**Study First Submit QC Date:** 2023-10-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ain Shams University

#### Responsible Party

**Investigator Affiliation:** Ain Shams University

**Investigator Full Name:** Maram Obeid

**Investigator Title:** Professor of Endodontics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Post Operative Pain

- Inflammation

**Keywords:**

- Cryotherapy

- substance P

- apical periodontitis

- post operative pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** DOUBLE

**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

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** no application of any type of cryotherapy.

**Label:** control group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: intraoral cryotherapy,ice gel

**Label:** cryotherapy group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cryotherapy group

**Description:** 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).

**Name:** intraoral cryotherapy,ice gel

**Other Names:**

- cold therapy,ice pack

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Level of post operative pain using 10 cm visual analoge scale (VAS)

**Time Frame:** after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit

#### Secondary Outcomes

**Description:** 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.

**Measure:** Level of inflammatory mediator substance P in apical fluid

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

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Ain Shams University

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Dentistry,Ain Shams University

**Name:** Maram F Obeid, Professor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** review the purpose of request

**Description:** detailed Statistical Analysis Plan

**Info Types:**

- SAP

**IPD Sharing:** YES

**Time Frame:** 2025 ,available for a year

### References Module

#### 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.

**PMID:** 29398090

**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.

**PMID:** 37222468

#### See Also Links

**Label:** worked on inflammatory mediators in similar matter

**URL:** https://dsu.journals.ekb.eg/article_192084.html

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000010483

- Term: Periapical Diseases

- ID: D000007571

- Term: Jaw Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M13395

- Name: Periapical Periodontitis

- Relevance: HIGH

- As Found: Apical Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M13393

- Name: Periapical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10601

- Name: Jaw Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000010485

- Term: Periapical Periodontitis

- ID: D000007249

- Term: Inflammation

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M243257

- Name: Methyl salicylate

- Relevance: LOW

- As Found: Unknown

- ID: M16161

- Name: Substance P

- Relevance: LOW

- As Found: Unknown

- ID: M17988

- Name: Neurokinin A

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
