Evaluation of The Effect of 980nm Diode Laser Intracanal Irradiation on Levels of Interleukin-8 Expression

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

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.

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: Placebo; Device: Intracanal Diode laser irradiation

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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; • Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated	Other: Placebo; 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
Other: Diode Laser group; Intracanal Diode laser application	Device: Intracanal Diode laser irradiation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6, 12, 24 hours and 7 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Dina A Morsy, lecturer, Cairo University; Principal Investigator: Sherif A Elkhodary, assoc. Prof, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): March 22, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Diode laser; Endodontic retreatment; IL-8 expression
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: DAMorsy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No