Clinical trial NCT05603988: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: Diode laser
Endodontic retreatment
IL-8 expression
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: quantification of IL-8
timeFrame: one week
Secondary outcomes:
measure: Postoperative pain
timeFrame: 6, 12, 24 hours and 7 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Cairo University
name: Dina A Morsy, lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Sherif A Elkhodary, assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.