Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.

Effect of Laser Activation on the Intraoperative and Post-treatment Pain in Single Visit Root Canal Treatment for Mandibular Molar Teeth With Acute Irreversible Pulpitis

Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis.

Study Overview

• Status: Recruiting
• Conditions: Decayed Teeth
• Intervention / Treatment: Device: iLASE DIODE LASERS

Detailed Description

AIM : To assess the intraoperative and postoperative pain incidence for single visit root canal treatment for mandibular molar teeth with acute irreversible pulpitis following laser activation.

MATERIALS AND METHODS: The study will account the patients who are referred to the Department of Endodontics,both male and female patients,with pain due to acute irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment. Subjects of age 13 to 70 years who met the inclusion criteria and responded positively to cold test will be included in the study.

Single visit root canal treatment with 2.5 mL of 2% lignocaine containing 1:80,000 adrenaline for an inferior alveolar block injection will be administered for each individual. After achieving anesthesia, patients who exhibit pain following access opening will be subjected to diode laser application on the pulp canal orifices. With regard to intraoperative pain, pre laser and post laser intraoperative pain incidence will be recorded. Once when the intraoperative pain incidence is reduced, patients will be reassessed for the need of additional anesthesia. If fully anesthetised, root canal procedure will be completed. Preoperative, intraoperative( before and laser application) pulse rate will also be measured. The levels of preoperative and post-operative pain at 24 hrs and 48 hrs for each patient will be recorded using a 10-point visual analog scale (VAS).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Madurai, India, 625001
    • Recruiting
    • CSI College of Dental Sciences and Research
    • Contact: SUBASHRI VISWANATHAN, MDS III YEAR; Phone Number: 9445659453; Email: shrimitha26@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with painful mandibular molar teeth due to caries with no history of medication intake before 7 days prior to root canal treatment
• Patients who respond exaggerated pain with or without lingering response on cold test

Exclusion Criteria:

• Patients who do not have pain upon access opening following local anesthesia administration
• Teeth with poor periodontal or restorative prognosis,
• Patients with serious systemic ailments or conditions hindering single visit root canal treatment
• patients not willing to participate in the post operative recall evaluation
• Teeth with anatomic variations and
• Allergic patients are excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser to reduce pain intraoperatively and post operatively; Diode lasers are used to assess its efficacy in reducing intraoperative and postoperative pain following root canal treatment in mandibular molar teeth with acute irreversible pulpitis	Device: iLASE DIODE LASERS; 940nm diode laser with 1.5 watts activated in a continuous mode and applied on to the canal orifices during root canal treatment to reduce intraoperative pain and further its effect on post operative pain is assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application	Change in pain is assessed in 10 point visual analog scale (VAS) before and after laser application.	procedure (during root canal treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postoperative pain measured using visual analog scale after root canal treatment	change in post-operative pain following laser application is assessed using 10 point visual analog scale (VAS) over phone call.	48 hours

Collaborators and Investigators

• Sponsor: CSI College of Dental Sciences and Research, Madurai

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CSICDSR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No