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

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ClinicalTrials.gov Identifier: NCT04735120
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Dr SUBASHRI V, CSI College of Dental Sciences and Research, Madurai

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

Condition or disease Intervention/treatment Phase
Decayed Teeth Device: iLASE DIODE LASERS Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application [ Time Frame: 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 :
  1. Change in postoperative pain measured using visual analog scale after root canal treatment [ Time Frame: 48 hours ]
    change in post-operative pain following laser application is assessed using 10 point visual analog scale (VAS) over phone call.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04735120


Locations
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India
Csi College of Dental Sciences and Research Recruiting
Madurai, India, 625001
Contact: SUBASHRI VISWANATHAN, MDS III YEAR    9445659453    shrimitha26@gmail.com   
Sponsors and Collaborators
CSI College of Dental Sciences and Research, Madurai
More Information
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Responsible Party: Dr SUBASHRI V, Principal investigator, CSI College of Dental Sciences and Research, Madurai
ClinicalTrials.gov Identifier: NCT04735120    
Other Study ID Numbers: CSICDSR
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases