Back to resultsEvaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression
Primary Purpose
Endodontically Treated Teeth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intracanal Diode laser irradiation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Diode laser, Endodontic retreatment, IL-8 expression
Eligibility Criteria
Inclusion Criteria: failed previously treated endodontic single-rooted teeth with chronic periapical lesions; with radiographic evidence of periapical radiolucency of not less than 1 cm diameter will be selected. Teeth with straight root canals. No contributory medical history. No previous administration of analgesics and/or antibiotics within the previous 2 weeks. Exclusion Criteria: Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings. Teeth with curved roots. Swelling or sinus tract. Mutilated teeth that interfere with proper isolation and seal between visits. Subjects with generalized periodontitis, or if the tooth has a probing depth of more than 3 mm. Subjects with uncontrolled diabetes or debilitating diseases. Pregnant or nursing females. Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Other
Arm Label
Placebo group
Diode Laser group
Arm Description
• Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated
Intracanal Diode laser application
Outcomes
Primary Outcome Measures
quantification of IL-8
- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before (S-1), after chemo-mechanical preparation (S-2), after intracanal irradiation or placebo effect (S-3) and last after one week of the treatment (S-4). The kit is used according to the manufacturer's recommendations.
Secondary Outcome Measures
Postoperative pain
Following the first visit, the modified visual analogue scale (VAS scale) with 11 points where 0 means no pain and 10 means maximum pain will be used to record patient's level of pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05603988
Brief Title
Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression
Official Title
Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression in Lesions Refractory to Endodontic Treatment: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
This clinical trial will be conducted to evaluate the amount of Il-8 expression before and after the application of intracanal irradiation with diode laser 980 nm versus placebo in failed endodontic cases with periapical lesions.
Detailed Description
Thorough medical and dental history for the eligible patients
Thorough intraoral and extraoral diagnosis
Local anesthesia
Isolation and removal of any previous filling or restoration
Removal of old gutta percha and establish patency to the full working length.
1st sample: will be collected using 3 sterile paper points
Chemo-mechanical preparation.
2nd sample collection
• Laser group: The canals will be irradiated with a high-power diode laser, with wavelength of 980 nm, maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter.
• Mock laser application (Placebo group): The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation, but not activated.
3rd sample collection
A piece of dry cotton will be placed in the access cavity, and then will be sealed with glass ionomer filling material
2nd visit: 1 week later, 4th sample collection then Obturation
Number of visits & follow up period: Two visits
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
Diode laser, Endodontic retreatment, IL-8 expression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
• Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated
Arm Title
Diode Laser group
Arm Type
Other
Arm Description
Intracanal Diode laser application
Intervention Type
Device
Intervention Name(s)
Intracanal Diode laser irradiation
Intervention Description
After endodontic retreatment, root canals will be irradiated with a 980 nm diode laser coupled with optical fibre 200 μm (Litemedics, Italy) with setting 1.2-watt power, in pulsed mode. The irradiation protocol will be of 5-sec irradiation followed by a 10-sec pause, which constituted one lasing cycle. The lasing cycle will be performed four times for each tooth. The tip will be positioned 1 mm short of the apex. Followed by activation during which it will be slowly dragged at a speed of approximately 2 mm/ sec in a way that the root canals will be irradiated from the apical to the coronal portion, in a helicoidal movement touching the canal walls.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
After endodontic retreatment, mock laser application (Placebo group) will be applied:
The fiberoptic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated
Primary Outcome Measure Information:
Title
quantification of IL-8
Description
- After collection of all the samples, quantification of IL-8 will be determined using ELISA kit before (S-1), after chemo-mechanical preparation (S-2), after intracanal irradiation or placebo effect (S-3) and last after one week of the treatment (S-4). The kit is used according to the manufacturer's recommendations.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Following the first visit, the modified visual analogue scale (VAS scale) with 11 points where 0 means no pain and 10 means maximum pain will be used to record patient's level of pain
Time Frame
6, 12, 24 hours and 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
failed previously treated endodontic single-rooted teeth with chronic periapical lesions; with radiographic evidence of periapical radiolucency of not less than 1 cm diameter will be selected.
Teeth with straight root canals.
No contributory medical history.
No previous administration of analgesics and/or antibiotics within the previous 2 weeks.
Exclusion Criteria:
Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
Teeth with curved roots.
Swelling or sinus tract.
Mutilated teeth that interfere with proper isolation and seal between visits.
Subjects with generalized periodontitis, or if the tooth has a probing depth of more than 3 mm.
Subjects with uncontrolled diabetes or debilitating diseases.
Pregnant or nursing females.
Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina A Morsy, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sherif A Elkhodary, assoc. Prof
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
ZIP/Postal Code
11553
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31372210
Citation
Morsy DA, Negm M, Diab A, Ahmed G. Postoperative pain and antibacterial effect of 980 nm diode laser versus conventional endodontic treatment in necrotic teeth with chronic periapical lesions: A randomized control trial. F1000Res. 2018 Nov 15;7:1795. doi: 10.12688/f1000research.16794.1. eCollection 2018.
Results Reference
background
PubMed Identifier
19196111
Citation
Kamma JJ, Vasdekis VG, Romanos GE. The effect of diode laser (980 nm) treatment on aggressive periodontitis: evaluation of microbial and clinical parameters. Photomed Laser Surg. 2009 Feb;27(1):11-9. doi: 10.1089/pho.2007.2233.
Results Reference
result
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Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression
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