Comparison Between Low-level Laser Therapy, Intracanal Cryotherapy and Their Combination, on Post-endodontic Pain Level

NCT04006717 | Completed

• 1 other identifier: MisrIU
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Statement of the problem: Postoperative pain following endodontic treatment is a common complication that might require analgesics for pain relief. Low-level laser therapy (LLLT) and Intracanal Cryotherapy (ICCT) are both recommended as non-pharmacological and non-invasive treatment modalities for management of painful situations. Aim of the study: This study is conducted to clinically evaluate and compare the effect of both LLLT and ICCT on post-endodontic pain (PEP) over 5 days in molars with symptomatic apical periodontitis (SAP) using visual analog scale (VAS). Materials \& Methods: This parallel arm, randomized clinical trial will involve 95 systemically free patients with SAP in molars. The patients will be randomly allocated to 5 equal groups as follows: control (no intervention), placebo (mock laser therapy), LLLT, ICCT and a combination of both. Postoperative pain levels after 6 hrs, 12 hrs, on 2nd day and 5th day are going to be assessed on the VAS and shall be noted. Data collected will be tabulated and statistically analysed.

Conditions

Low-level Light Therapy; Cryotherapy

Keywords

Post-endodontic pain; Low-level laser; Intracanal cryotherapy

Outcome Measures

Primary Outcomes (1)

• Post-endodontic pain

  Score on Visual Analogue scale, ranging from 1 (No pain) to 10 (Worst pain)

  5 days

Study Arms (5)

Control

NO INTERVENTION

Routine root canal treatment

Low-Level Laser Placebo

PLACEBO COMPARATOR

Patient informed that laser will be applied but device won't be turned on

Device: Low Level Laser therapy

Low-Level Laser Therapy

EXPERIMENTAL

Low-Level Laser Therapy following root canal treatment

Device: Low Level Laser therapy

Intracanal Cryotherapy

EXPERIMENTAL

Cold saline irrigation before obturation

Procedure: Intra canal Cryotherapy

Combination of LLLT and ICCT

EXPERIMENTAL

Both cold saline irrigation before obturation and Low-level laser Therapy after root canal treatment

Device: Low Level Laser therapy; Procedure: Intra canal Cryotherapy

Interventions

Low Level Laser therapy DEVICE

Diode laser (EPIC™ BIOLASE) with wavelength 940nm

Combination of LLLT and ICCT; Low-Level Laser Placebo; Low-Level Laser Therapy

Intra canal Cryotherapy PROCEDURE

Irrigation with cold saline 2-4 C

Combination of LLLT and ICCT; Intracanal Cryotherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients having a molar tooth with symptomatic apical periodontitis indicated for root canal treatment.
• Systemically free patients. ASA I
• Teeth with mature apex.
• Teeth without root resorption.

You may not qualify if:

• Patients with other pulpal diagnoses.
• Medically compromised patients.
• Pregnant females.
• Patients taking analgesics or anti-inflammatory drugs.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International University

Cairo, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: June 24, 2019
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 18, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)