Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues

Efficiency of Diode Laser Activated Irrigation on Healing of Periapical Tissues (A Randomized Clinical Trial )

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

Study Overview

• Status: Completed
• Conditions: Periapical Diseases
• Intervention / Treatment: Device: Diode laser; Other: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser activated irrigation LAI; Diode Laser activated irrigation	Device: Diode laser; Diode laser activated irrigation; Other Names: LAI
Placebo Comparator: conventional root canal treatment; mock LAI , conventional root canal treatment 2.5% sodium hypochlorite	Other: Placebo; mock Laser activated irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess post-operative healing using CBCT in a period of 12 month when Laser activated irrigation was used during root canal treatment	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Maram Obeid, PhD, Ainshams University; Study Chair: Ehab Hassanien, PhD, Ainshams University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: March 7, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: CBCT; Diode laser; low level laser therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases
• Other Study ID Numbers: END 16-15D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No