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

NCT05603988 | Completed

• 1 other identifier: DAMorsy
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth

Keywords

Diode laser; Endodontic retreatment; IL-8 expression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain

  6, 12, 24 hours and 7 days

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

• 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

Diode Laser group

OTHER

Intracanal Diode laser application

Device: Intracanal Diode laser irradiation

Interventions

Intracanal Diode laser irradiation DEVICE

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.

Diode Laser group

Placebo OTHER

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11553, Egypt

Location

Related Publications (2)

• 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.

  PMID: 31372210 BACKGROUND

• 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.

  PMID: 19196111 RESULT

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dina A Morsy, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

• Sherif A Elkhodary, assoc. Prof

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in endodontic department, Cairo university

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: April 14, 2021
• Primary Completion: March 22, 2022
• Study Completion: April 27, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)