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

NCT ID: NCT06657664

Last Updated: 2024-10-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irriversible Pulpitis With Apical Peridontitis Hot Tooth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized clinical study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

all participants have an equal chance to be enrolled in any of the study groups. This pattern was the most suitable way to ensure the balance of the anonymous prognostic factors in the participants between the three groups thus, eliminating the selection or allocation bias

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control Group

all occlusal contacts are reduced by 1 mm

Group Type ACTIVE_COMPARATOR

Control (Standard treatment)

Intervention Type PROCEDURE

, all occlusal contacts were reduced by 1 mm

intracanal cryotherapy

the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes

Group Type ACTIVE_COMPARATOR

cryotherapy with sterile saline at 2.5ºC

Intervention Type PROCEDURE

the root canals are given a final irrigation with 20 mL cold (2.5oC) saline solution for 5 minutes before obturation

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

Group Type ACTIVE_COMPARATOR

intaoral cryotherapy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Both intracanal and intraoral cryotherapy

Intervention Type PROCEDURE

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.

Low Level Laser Therapy

laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively.

Group Type ACTIVE_COMPARATOR

Low Level Laser Therapy

Intervention Type DEVICE

laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type 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.

Intervention Type PROCEDURE

Low Level Laser Therapy

laser irradiation on the soft tissues covering the apices of the tooth on both buccal and palatal surfaces respectively

Intervention Type DEVICE

Control (Standard treatment)

, all occlusal contacts were reduced by 1 mm

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

iced intracanal saline intracanal cryotherapy photobiomodulation LLLT cold lasers occlusal reduction

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rawda Nashy

Rawda Nashy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta university

Tanta, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TantaU 55

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Cryotherapy on Postoperative Pain for Pulpotomy
NCT07245004 ACTIVE_NOT_RECRUITING EARLY_PHASE1