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

Not Applicable

Completed

• Conditions: Endodontically Treated Teeth

• 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

Study Timeline

• Study Start: 2021-04-14
• Primary Completion: 2022-03-22
• Study Completion: 2022-04-27
• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-11-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

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

Primary Outcome Measures

Name	Time	Method
quantification of IL-8	one 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

Name	Time	Method
Postoperative pain	6, 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