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

Decayed Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04735120
• Other study ID #: CSICDSR
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: January 2021
• Source: CSI College of Dental Sciences and Research, Madurai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Decayed Teeth
• Dental Caries

Intervention

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

Locations

Country	Name	City	State
India	Csi College of Dental Sciences and Research	Madurai

Sponsors (1)

Lead Sponsor	Collaborator
CSI College of Dental Sciences and Research, Madurai

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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