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

NCT06657664 | Completed DMC FDA Device

• 1 other identifier: TantaU 55
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irriversible Pulpitis With Apical Peridontitis; Hot Tooth

Keywords

cryotherapy Low Level Laser Therapy LLLT single visit endodontic treatment irriversible pulpitis Apical peridontitis

Outcome Measures

Primary Outcomes (1)

• post operative pain

  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

Study Arms (5)

control Group

ACTIVE COMPARATOR

all occlusal contacts are reduced by 1 mm

Procedure: Control (Standard treatment)

intracanal cryotherapy

ACTIVE COMPARATOR

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

intraoral cryotherapy group

ACTIVE COMPARATOR

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

Both intracanal and intraoral cryotherapy

ACTIVE COMPARATOR

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

Low Level Laser Therapy

ACTIVE COMPARATOR

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

Device: Low Level Laser Therapy

Interventions

cryotherapy with sterile saline at 2.5ºC PROCEDURE

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

Also known as: iced intracanal saline, intracanal cryotherapy

intracanal cryotherapy

intaoral cryotherapy 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

intraoral cryotherapy group

Both intracanal and intraoral cryotherapy 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.

Both intracanal and intraoral cryotherapy

Low Level Laser Therapy DEVICE

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

Also known as: photobiomodulation, LLLT, cold lasers

Low Level Laser Therapy

Control (Standard treatment) PROCEDURE

, all occlusal contacts were reduced by 1 mm

Also known as: occlusal reduction

control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Egypt

Location

MeSH Terms

Interventions

Cryotherapy; Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Laser Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rawda Nashy

Model Details: This is a randomized clinical study.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: August 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 10, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

EG (1)