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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Endodontically Treated Teeth

Intervention / Treatment
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* Device: Intracanal Diode laser irradiation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>• 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<br>* 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<br>|
| Other: Diode Laser group<br>Intracanal Diode laser application | Device: Intracanal Diode laser irradiation<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diode laser, Endodontic retreatment, IL-8 expression