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

NCT ID: NCT06082479

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-02-01

Brief Summary

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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

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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

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Post Operative Pain Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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

Study Groups

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control group

no application of any type of cryotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

cryotherapy group

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.

Group Type ACTIVE_COMPARATOR

intraoral cryotherapy,ice gel

Intervention Type 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).

Interventions

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intraoral 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).

Intervention Type PROCEDURE

Other Intervention Names

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cold therapy,ice pack

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Maram Obeid

Professor of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maram F Obeid, Professor

Role: STUDY_DIRECTOR

Faculty of Dentistry,Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 29398090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37222468 (View on PubMed)

Related Links

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

worked on inflammatory mediators in similar matter

Other Identifiers

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304

Identifier Type: -

Identifier Source: org_study_id

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