NCT04315259

Brief Summary

Study is a Randomized clinical trial conducted at Endodontic department- Ain Shams university Cairo. Egypt. 180 eligible patients were selected and included in the study to assess the post-endodontic pain of diode laser activated irrigation versus soft tissue diode laser application post obturation versus conventional root canal treatment .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ 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
12 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 7, 2020

Last Update Submit

March 17, 2020

Conditions

Periapical Diseases

Keywords

Diode laserlow laser therapy

Outcome Measures

Primary Outcomes (3)

  • Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain

    24 hours

  • Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain

    48 hours

  • Measure change in post-operative pain after Laser intervention using a visual analogue scale (VAS) questionnaire where 0 indicates no pain and 10 indicates severe pain

    72 hours

Study Arms (3)

Laser activated irrigation

EXPERIMENTAL

conventional root canal treatment was done , 2.5% sodium hypochlorite was used and was activated by 980 nm with a repeated pulse mode using a pulse duration of 5 s and a pulse interval of 0.2 ms. The laser irradiation will be 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 (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100)

Device: Diode laser

Soft tissue laser application

EXPERIMENTAL

Endodontically treated teeth by virtue of a dental applicator positioned at a right angle to the mucosa at the level of the apices. Application of the laser probe was applied to both the buccal and lingual mucosae overlying the apices of the target tooth. Total exposure time for each tooth was 60 seconds (a dose = 70 j/cm2 for analgesia) The laser unit used in this study used was a diode laser (Lite Medics 1.00Watt serial number 148 Ver.SwvM. 150VS108VT.100) of wavelength 980nm and Max power 15WCW Class IV Laser Product

Device: Diode laser

conventional root canal

NO INTERVENTION

conventional root canal treatment with irrigation of sodium hypochlorite 2.5% with no laser intervention

Interventions

Diode laserDEVICE

irrigation activated by diode laser versus soft tissue laser application therapy

Also known as: Low laser therapy, soft laser, Lite medics serial number 148 Ver.SwvM. 150VS108VT.100
Laser activated irrigationSoft tissue laser application

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

MeSH Terms

Conditions

Periapical Diseases

Interventions

Lasers, SemiconductorLow-Level Light Therapy

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesLaser TherapyTherapeuticsPhototherapy

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
study is Single Blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 7, 2020

First Posted

March 19, 2020

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

January 1, 2020

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)