search
Back to results

Efficiency of Diode Laser in Control of Post-endodontic Pain

Primary Purpose

Periapical Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Diode laser
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Diseases focused on measuring Diode laser, low laser therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult patients age between 18-50 years
  • Medically free patients.
  • Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
  • Preoperative Pain
  • Sensitivity to percussion
  • Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
  • Occlusal contact with opposing teeth

Exclusion Criteria:

  • Pregnant females.
  • Patients having a significant systemic disorder or history of drug abuse
  • Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
  • Patients having bruxism or clenching
  • Teeth having:

    • No occlusal contact
    • No sensitivity to percussion
    • Greater than grade I mobility.
    • Pocket depth greater than 5mm.
    • No possible restorability
    • Procedural errors
    • Previous Root canal treatment
    • Open apex

Sites / Locations

  • Endodontic department - Faculty of Dentistry Ainshams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Laser activated irrigation

Soft tissue laser application

conventional root canal

Arm Description

conventional root canal treatment was done , 2.5% sodium hypochlorite was used and was activated by 980 nm with a repeated pulse mode using a pulse duration of 5 s and a pulse interval of 0.2 ms. The laser irradiation will be delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100)

Endodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product

conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with no laser intervention

Outcomes

Primary Outcome Measures

Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain

Secondary Outcome Measures

Full Information

First Posted
March 7, 2020
Last Updated
March 17, 2020
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT04315259
Brief Title
Efficiency of Diode Laser in Control of Post-endodontic Pain
Official Title
Efficiency of Diode Laser in Control of Post-endodontic Pain (A Randomized Clinical Trial )
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 180 eligible patients were selected and included in the study to assess the post-endodontic pain of diode laser activated irrigation versus soft tissue diode laser application post obturation versus conventional root canal treatment .
Detailed Description
Sample size is 180 180 Patients were randomly distributed in 3 groups , one group of patients received laser therapy after root canal treatment and the other group received disinfection by Diode laser activated irrigation , the third group received no treatment just conventional Root canal treatment. • Patients were equally divided into 3 groups (n=60 in each group ) The study in a Single blinded Randomized clinical trial , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not have a laser session following root canal treatment to test its ability to control pain , the consent will also require them to take a questionnaire at home to measure their pain level and they were willingly do it. Conventional root canal treatment were done to selected teeth , and any cases with procedural errors were excluded. Group A Laser activated irrigation :Disinfection were done by using 5 ml of 2.5% sodium hypochlorite irrigation for 1 minute. Irrigation will be performed with a 30-gauge needle side vented The irrigation needles were introduced passively up to 2 mm away the working length. After irrigation Laser treatment will be performed with a diode laser, at a wavelength of 980 nm with a repeated pulse mode using a pulse duration of 5s per canal and a pulse interval of 0.2 ms. The laser irradiation were delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part Group B Soft tissue laser application : Endodontically treated teeth were targeted by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe were applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) by the co-investigator The laser unit used in this study will be a diode laser (Lite Medics 1.00 Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15 WCW Class IV Laser Product ) in continuous wave mode Group C : conventional root canal treatment : no laser intervention Patients were instructed to record their post-endodontic pain by VAS where 0 stands for no pain and 10 stands for severe pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Diseases
Keywords
Diode laser, low laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
study is Single Blinded
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser activated irrigation
Arm Type
Experimental
Arm Description
conventional root canal treatment was done , 2.5% sodium hypochlorite was used and was activated by 980 nm with a repeated pulse mode using a pulse duration of 5 s and a pulse interval of 0.2 ms. The laser irradiation will be delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100)
Arm Title
Soft tissue laser application
Arm Type
Experimental
Arm Description
Endodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product
Arm Title
conventional root canal
Arm Type
No Intervention
Arm Description
conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with no laser intervention
Intervention Type
Device
Intervention Name(s)
Diode laser
Other Intervention Name(s)
Low laser therapy, soft laser, Lite medics serial number 148 Ver.SwvM. 150VS108VT.100
Intervention Description
irrigation activated by diode laser versus soft tissue laser application therapy
Primary Outcome Measure Information:
Title
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Time Frame
24 hours
Title
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Time Frame
48 hours
Title
Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult patients age between 18-50 years Medically free patients. Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp Preoperative Pain Sensitivity to percussion Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal Occlusal contact with opposing teeth Exclusion Criteria: Pregnant females. Patients having a significant systemic disorder or history of drug abuse Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively. Patients having bruxism or clenching Teeth having: No occlusal contact No sensitivity to percussion Greater than grade I mobility. Pocket depth greater than 5mm. No possible restorability Procedural errors Previous Root canal treatment Open apex
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maram Obeid, PhD
Organizational Affiliation
Ainshams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ehab Hassanien, PhD
Organizational Affiliation
Ainshams University
Official's Role
Study Chair
Facility Information:
Facility Name
Endodontic department - Faculty of Dentistry Ainshams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficiency of Diode Laser in Control of Post-endodontic Pain

We'll reach out to this number within 24 hrs