Effect of Cryotherapy and Laser Application on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases (LLLT)

October 23, 2024 updated by: Rawda Nashy, Tanta University

Effect of Cryotherapy and Laser on Post-Operative Pain in Single Visit Endodontically Treated Symptomatic Apical Periodontitis Cases

This study compare the effect of applying ice after single visit endodontic treatment with lasers to reduce post operative pain .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

one of the most popular complications after single visit endodontic treatment is pain either spontaneous or on biting so in this study we choose one of the most difficult and challenging cases " Hot tooth " to compare lasers and cryotherapy different applications to reduce post operative pain after single visit endodontic treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • Vital teeth display symptomatic apical periodontitis (Symptomatic apical periodontitis was determined based on the clinical symptoms of severe preoperative pain (visual analogue scale [VAS] > 60) and severe percussion pain (VAS > 60).

    • Teeth, with a periapical index score (PAI) of 2 or 3 indicating small changes in bone structure and slight mineral loss respectively.
    • Mobility less than 1 mm in either direction.
    • Absence of periodontal pocket around the tooth.
    • Symptomatic pulpitis with spontaneous pain or lingered by cold or heat.
    • Teeth without pus or inflammatory exudates draining through the canal.
    • Teeth without anatomic variations

Exclusion Criteria:

  • • Patient with any systemic disease.

    • Immunocompromised patients.
    • Pregnant or lactating patients.
    • Apparently narrow roots in which apical preparation with the #40 file would be overzealous.
    • Retreatment cases.
    • Necrotic painful teeth with absence of sinus tract for drainage.
    • Patients on analgesics or sedative medication up to 6 hours before treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control Group
all occlusal contacts are reduced by 1 mm
Procedure: Control (Standard treatment)
, all occlusal contacts were reduced by 1 mm
Other Names:
  • occlusal reduction
Active Comparator: intracanal cryotherapy
the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes
Procedure: cryotherapy with sterile saline at 2.5ºC
the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes before obturation
Other Names:
  • iced intracanal saline
  • intracanal cryotherapy
Active Comparator: intraoral cryotherapy group
ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezing sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes
Procedure: intaoral cryotherapy
ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezed sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes
Active Comparator: Both intracanal and intraoral cryotherapy
the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes , the canal is obturated and then ice sticks (wrapped in sterile gauze if needed) using plastic pipette droppers filled with freezing sterile water are placed intraorally in the mouth on the apices of the treated tooth on both buccal and palatal sides for 30 minutes.
Procedure: Both intracanal and intraoral cryotherapy
Canal is irrigated with iced saline for 5 minutes before obturation . Root canal is obturated and coronal restoration is done. Then, application of intraoral cryotherapy is performed by ice sticks for 30 minutes.
Active Comparator: Low Level Laser Therapy
laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively.
Device: Low Level Laser Therapy
laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively
Other Names:
  • LLLT
  • photobiomodulation
  • cold lasers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative pain
Time Frame: preoperative, after 24 hours, on the third , fifth, one week & two weeks after treatment
post operative pain and pain on percussion is tested using visual analogue scale
preoperative, after 24 hours, on the third , fifth, one week & two weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

October 10, 2024

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TantaU 55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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