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Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues

Primary Purpose

Periapical Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Soft tissue Diode laser application
Placebo
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 level laser therapy, CBCT

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 Type

Experimental

Placebo Comparator

Arm Label

Soft tissue laser Diode laser application

conventional root canal treatment

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

Placebo : conventional root canal conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with mock laser intervention

Outcomes

Primary Outcome Measures

Assess post-operative healing in a period of 12 month when using Soft tissue diode laser application post-operative using CBCT

Secondary Outcome Measures

Full Information

First Posted
March 7, 2020
Last Updated
March 16, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04311879
Brief Title
Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues
Official Title
Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of soft tissue diode laser application versus conventional root canal treatment using CBCT
Detailed Description
Sample size is 24 24 Patients were randomly distributed in 2 groups , one group of patients received soft tissue laser therapy after root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , 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 Group A 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 B : Placebo : conventional root canal treatment : mock laser intervention A CBCT was taken preoperative and after 12 month postoperative, both linear and volumetric measurements were calculated

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 level laser therapy, CBCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blinded
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soft tissue laser Diode 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 treatment
Arm Type
Placebo Comparator
Arm Description
Placebo : conventional root canal conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with mock laser intervention
Intervention Type
Device
Intervention Name(s)
Soft tissue Diode laser application
Other Intervention Name(s)
Low laser therapy
Intervention Description
post-operative soft tissue diode laser application
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
mock diode laser application
Primary Outcome Measure Information:
Title
Assess post-operative healing in a period of 12 month when using Soft tissue diode laser application post-operative using CBCT
Time Frame
12 months

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

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Efficiency of Soft Tissue Diode Laser Application on Healing of Periapical Tissues

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