NCT04311905

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 7, 2020

Last Update Submit

March 16, 2020

Conditions

Keywords

Diode laserCBCTlow level laser therapy

Outcome Measures

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

    12 months

Study Arms (2)

Laser activated irrigation LAI

EXPERIMENTAL

Diode Laser activated irrigation

Device: Diode laser

conventional root canal treatment

PLACEBO COMPARATOR

mock LAI , conventional root canal treatment 2.5% sodium hypochlorite

Other: Placebo

Interventions

Diode laser activated irrigation

Also known as: LAI
Laser activated irrigation LAI
PlaceboOTHER

mock Laser activated irrigation

conventional root canal treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endodontic department - Faculty of Dentistry Ainshams University

Cairo, Egypt

Location

Related Publications (1)

  • Hamdy Ismail H, Obeid MF, ElSaid Hassanein E. The efficiency of single-session photobiomodulation on healing of periapical bone lesions using CBCT: a randomized clinical trial. Lasers Med Sci. 2025 Jan 23;40(1):31. doi: 10.1007/s10103-024-04242-5.

MeSH Terms

Conditions

Periapical Diseases

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Maram Obeid, PhD

    AinShams University

    STUDY DIRECTOR
  • Ehab Hassanien, PhD

    Ainshams University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

March 7, 2020

First Posted

March 17, 2020

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations