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CompletedNCT04311905Updated Mar 18, 2020

Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues

An interventional study of Diode laser and Placebo in Periapical Diseases, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jul 2017, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 24 eligible patients were selected and included in the study to compare healing ability of diode laser activated irrigation versus conventional root canal treatment using CBCT

Read the detailed description

Sample size is 24 , 24 Patients were randomly distributed in 2 groups , one group of patients received laser activated irrigation LAI during root canal treatment and the other group received no treatment just conventional RCT. • Patients were equally divided into 2 groups (n=12 in each group ) The study in a Single blinded RCT , Numbers for patients will be generated and distributed randomly in a table on an Excel sheet, and in front of each number either a letter (C) for control or (I) for intervention will be typed After patients were selected in the study they will be asked to fill in a consent form , that states that they are part of a clinical trial and that they may or may not receive a laser activated irrigation Group A LAI :Disinfection were done by using 5 ml of 2.5% sodium hypochlorite irrigation for 1 minute. Irrigation will be performed with a 30-gauge needle side vented The irrigation needles were introduced passively up to 2 mm away the working length. After irrigation Laser treatment will be performed with a diode laser, at a wavelength of 980 nm with a repeated pulse mode using a pulse duration of 5sec per canal and a pulse interval of 0.2 ms. The laser irradiation were delivered for 1 minute into the canal up to 1 mm short of the working length, with circling movements from the apical part moving towards the coronal part Group B : received mock laser intervention , conventional Root canal treatment with 2.5% sodium hypochlorite CBCT was taken pre-operative and another one was taken after 12 month , both volumetric and linear measurements were calculated

02

Conditions studied

  • Periapical Diseases

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Keywords

  • Diode laser
  • CBCT
  • low level laser therapy
03

In context

Periapical Diseases

44 studies on the registry are indexed under Periapical Diseases; 12 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 35 interventional studies indexed under Periapical Diseases.

Browse Periapical Diseases studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult patients age between 18-50 years
  • Medically free patients.
  • Patients suffering from acute or chronic infection with symptomatic apical periodontitis with Necrotic pulp
  • Preoperative Pain
  • Sensitivity to percussion
  • Periapical radiographic X-ray showing periapical lesion with no gutta percha in canal
  • Occlusal contact with opposing teeth

Exclusion criteria

Exclusion Criteria:

  • Pregnant females.
  • Patients having a significant systemic disorder or history of drug abuse
  • Patients who had administrated analgesics or antibiotics during the last 12 hours preoperatively.
  • Patients having bruxism or clenching
  • Teeth having:

    • No occlusal contact
    • No sensitivity to percussion
    • Greater than grade I mobility.
    • Pocket depth greater than 5mm.
    • No possible restorability
    • Procedural errors
    • Previous Root canal treatment
    • Open apex
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Laser activated irrigation LAI

    Diode Laser activated irrigation

    Device: Diode laser

  • Placebo comparator
    conventional root canal treatment

    mock LAI , conventional root canal treatment 2.5% sodium hypochlorite

    Other: Placebo

Interventions

  • DeviceDiode laser

    Diode laser activated irrigation

    Also known as: LAI

  • OtherPlacebo

    mock Laser activated irrigation

06

What researchers measure

Primary outcomes

  1. Assess post-operative healing using CBCT in a period of 12 month when Laser activated irrigation was used during root canal treatment

    Time frame: 12 months

07

Study locations

1 site
  • Endodontic department - Faculty of Dentistry Ainshams University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04311905
Lead sponsor
Ain Shams University
Responsible party
Hend Hamdy Ismail (PhD candidate, Ain Shams University) — Principal investigator
First posted
Mar 17, 2020
Start date
Jul 1, 2017
Primary completion
Jul 1, 2019
Completion
Jan 1, 2020
Last update
Mar 18, 2020

Study contacts

Maram Obeid, PhD
study director · AinShams University
Ehab Hassanien, PhD
study chair · Ainshams University

Oversight

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

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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