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

NCT ID: NCT05603988

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2022-04-27

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

Conditions

Endodontically Treated Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo group

• Mock laser application (Placebo group): The fiber optic tip will be inserted inside the root canal, mimicking the laser irradiation group, but not activated

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

Diode Laser group

Intracanal Diode laser application

Group Type: OTHER

Intracanal Diode laser irradiation

Intervention Type: 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.

Interventions

Intracanal Diode laser irradiation

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.

Intervention Type: DEVICE

Placebo

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Ahmed Morsy

lecturer in endodontic department, Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina A Morsy, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Sherif A Elkhodary, assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of Dentistry

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 31372210 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19196111 (View on PubMed)

Other Identifiers

DAMorsy

Identifier Type: -

Identifier Source: org_study_id