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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05603988
Collaborator
(none)
28
1
2
12.4
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intracanal Diode laser irradiation
  • Other: Placebo
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 14, 2021
Actual Primary Completion Date :
Mar 22, 2022
Actual Study Completion Date :
Apr 27, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 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

Other: 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

Other: Diode Laser group

Intracanal Diode laser application

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry Cairo Egypt 11553

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Dina A Morsy, lecturer, Cairo University
  • Principal Investigator: Sherif A Elkhodary, assoc. Prof, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dina Ahmed Morsy, lecturer in endodontic department, Cairo university, Cairo University
ClinicalTrials.gov Identifier:
NCT05603988
Other Study ID Numbers:
  • DAMorsy
First Posted:
Nov 3, 2022
Last Update Posted:
Nov 16, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dina Ahmed Morsy, lecturer in endodontic department, Cairo university, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2022