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

Not Applicable
Completed
Conditions
Endodontically Treated Teeth
Interventions
Other: Placebo
Device: Intracanal Diode laser irradiation
Registration Number
NCT05603988
Lead Sponsor
Cairo University
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo groupPlacebo• Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated
Diode Laser groupIntracanal Diode laser irradiationIntracanal Diode laser application
Primary Outcome Measures
NameTimeMethod
quantification of IL-8one week

- 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
NameTimeMethod
Postoperative pain6, 12, 24 hours and 7 days

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

Trial Locations

Locations (1)

Faculty of Dentistry

🇪🇬

Cairo, Egypt

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