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

Not Applicable

• Conditions: Decayed Teeth
• Interventions: Device: iLASE DIODE LASERS

• Registration Number: NCT04735120
• Lead Sponsor: CSI College of Dental Sciences and Research, Madurai

Brief Summary

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

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 Timeline

• Study Start: 2020-02-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-30
• Primary Completion: 2021-02-01
• Study First Posted: 2021-02-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser to reduce pain intraoperatively and post operatively	iLASE DIODE LASERS	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Csi College of Dental Sciences and Research; 🇮🇳 Madurai, India