Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

NCT ID: NCT05041738

Last Updated: 2021-09-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-10-01

Brief Summary

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The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intraoral Cryotherapy

Group Type EXPERIMENTAL

Intraoral Cryotherapy

Intervention Type PROCEDURE

small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth

Intracanal Cryotherapy

Group Type ACTIVE_COMPARATOR

Intracanal Cryotherapy

Intervention Type PROCEDURE

Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant

Interventions

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Intraoral Cryotherapy

small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth

Intervention Type PROCEDURE

Intracanal Cryotherapy

Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Systemically healthy patient (ASA I or II).

Mandibular first molar teeth with:

* Preoperative sharp pain and symptomatic apical periodontitis
* Absence or slight widening in the periodontal ligament (PDL).
* Vital response of pulp tissue to cold pulp tester (ethyl chloride spray) .
* Positive response to percussion test

Exclusion Criteria

1. Medically compromised patients.
2. Pregnant women.
3. Patients reporting bruxism or clenching.
4. Patients allergic to ciprofloxacin or metronidazole.
5. Teeth associated with acute periapical abscess and/or swelling.
6. Greater than grade I mobility or pocket depth greater than 5mm.
7. Size of periapical radiolucency is greater than 8 mm.
8. No restorability: Hopeless tooth.
9. Immature teeth.
10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Minimum Eligible Age

20 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Toka Mohamed Ezzat Kamel Soliman

Principal investigator, Resident at faculty of dentistry, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Toka M Ezzat, B.D.S. (Cairo University)

Role: CONTACT

01005137002 ext. 002

References

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Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.

Reference Type BACKGROUND
PMID: 32386857 (View on PubMed)

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)

Other Identifiers

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ENDO 3-3-5 8/9/2021

Identifier Type: -

Identifier Source: org_study_id

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