Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.
Primary Purpose
Decayed Teeth
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
iLASE DIODE LASERS
Sponsored by
About this trial
This is an interventional treatment trial for Decayed Teeth
Eligibility 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
Sites / Locations
- Csi College of Dental Sciences and ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laser to reduce pain intraoperatively and post operatively
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04735120
First Posted
January 26, 2021
Last Updated
February 2, 2021
Sponsor
CSI College of Dental Sciences and Research, Madurai
1. Study Identification
Unique Protocol Identification Number
NCT04735120
Brief Title
Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CSI College of Dental Sciences and Research, Madurai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decayed Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser to reduce pain intraoperatively and post operatively
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
iLASE DIODE LASERS
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application
Description
Change in pain is assessed in 10 point visual analog scale (VAS) before and after laser application.
Time Frame
procedure (during root canal treatment)
Secondary Outcome Measure Information:
Title
Change in postoperative pain measured using visual analog scale after root canal treatment
Description
change in post-operative pain following laser application is assessed using 10 point visual analog scale (VAS) over phone call.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Csi College of Dental Sciences and Research
City
Madurai
ZIP/Postal Code
625001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SUBASHRI VISWANATHAN, MDS III YEAR
Phone
9445659453
Email
shrimitha26@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.
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