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CompletedNCT05603988Updated Aug 21, 2023

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

An interventional study of Intracanal Diode laser irradiation and Placebo in Endodontically Treated Teeth, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2021, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Endodontically Treated Teeth

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Keywords

  • Diode laser
  • Endodontic retreatment
  • IL-8 expression
03

In context

Tooth, Nonvital

118 studies on the registry are indexed under Tooth, Nonvital; 18 are open to participants now.

This study's enrollment of 28 is below the median of 50 across 108 interventional studies indexed under Tooth, Nonvital.

Browse Tooth, Nonvital studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • 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

  • Other
    Diode Laser group

    Intracanal Diode laser application

    Device: Intracanal Diode laser irradiation

Interventions

  • DeviceIntracanal 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.

  • OtherPlacebo

    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

06

What researchers measure

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.

    Time frame: one week

Secondary outcomes

  1. Postoperative pain

    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

    Time frame: 6, 12, 24 hours and 7 days

07

Study locations

1 site
  • Faculty of Dentistry
    Cairo, 11553, Egypt
08

References and documents

Publications

  • 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. PubMed 31372210 ↗
  • 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. PubMed 19196111 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05603988
Lead sponsor
Cairo University
Responsible party
Dina Ahmed Morsy (lecturer in endodontic department, Cairo university, Cairo University) — Principal investigator
First posted
Nov 3, 2022
Start date
Apr 14, 2021
Primary completion
Mar 22, 2022
Completion
Apr 27, 2022
Last update
Aug 21, 2023

Study contacts

Dina A Morsy, lecturer
principal investigator · Cairo University
Sherif A Elkhodary, assoc. Prof
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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