Laser Activated Irrigation Versus Passive Ultrasonic Irrigation

Evaluation of Post-operative Pain and Bacterial Reduction Following Laser Activated Irrigation Versus Passive Ultrasonic Irrigation in Necrotic Single Rooted Teeth: A Randomized Clinical Trial

assessment of bacterial reduction and post-operative pain following Laser activated irrigation using sodium hypochlorite and a 980 nm diode laser device as an adjunct to conventional root canal treatment, and comparing it with passive ultrasonic irrigation using sodium hypochlorite and an ultrasonic device in patients with single rooted asymptomatic necrotic teeth.

Study Overview

• Status: Unknown
• Conditions: Pulp Necroses
• Intervention / Treatment: Device: Laser activated irrigation; Device: Passive ultrasonic irrigation

Detailed Description

After thorough diagnosis and recording of the patient's perceived preoperative pain using the numeric rating scale (NRS), which should be zero. Patients with single rooted necrotic teeth will be randomly divided into two groups for endodontic treatment in a single visit:

Group LAI (in which laser activated irrigation will be done) and group PUI (in which passive ultrasonic irrigation will be done).

The teeth are anesthetized and isolation is done. the clamp, tooth crown and rubber dam are disinfected using 2.5% sodium hypochlorite and 30% hydrogen peroxide then sodium thiosulphate to neutralize their effects.

Removal of caries and defective restorations is done, followed by access cavity preparation using round burs and fine tapered stones. then the first microbiological sample is taken using paper points. Afterwards root canal preparation is done using Protaper Next files and irrigation is done using 2.5% sodium hypochlorite and a 30 -gauge side vented needle.

After chemomechanical preparation of the canal, the second microbiological sample is taken, afterwards the canals are filled with sodium hypochlorite and according to the group, the following is done:

In group LAI: the 200 micrometer fibre of the diode laser device enters the root canal and the device is activated at a setting of 980 nm and 1.5 Watts for 5 seconds, repeated 4 times with a 10 seconds gap in between.

In group PUI: the ultrasonic device is activated inside the canal using a passive non cutting tip and kept activated for 1 minute.

Then, irrigation with saline solution is done then the third microbiological sample is taken, afterwards obturation is done and temporization. the patient is referred to the restorative dentistry clinic to complete the restoration of his tooth.

The patient is instructed to record his pain at 6,12,24 and 48 hours postoperatively and the microbiological samples are analyzed

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amr Ahmed, MSc; Phone Number: +201224382216; Email: dramrayman1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medically free patients.

• Patients with necrotic pulp in single rooted teeth with:

  • Closed apex.
  • Associated with or without periapical radiolucency.
  • No response of vital pulp with the electric pulp tester.
• Healthy dental and periodontal status.
• Positive patients' acceptance for participation in the study.

Exclusion Criteria i. Patients on medication for chronic pain. ii. Patients with pre-operative pain. iii. Patients having significant systemic disorders. iv. Patients with two or more adjacent teeth requiring root canal therapy. v. Patients who had received antibiotics in the last month. vi. Teeth that have:

• Vital pulp tissues.
• Association with swelling or fistulous tract.
• Acute peri-apical abscess.
• Greater than grade I mobility.
• Pocket depth greater than 5mm.
• No possible restorability.
• Previous endodontic treatment.
• Open apex.
• Extra coronal restorations.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser activated irrigation; Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device	Device: Laser activated irrigation; Diode laser at 980 nm, power of 1.5W, for 5 seconds inside the canal along with sodium hypochlorite, repeated 4 times with a gap of 10 seconds in between
Active Comparator: Passive ultrasonic irrigation; passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device	Device: Passive ultrasonic irrigation; ultrasonic activation inside the canal for 1 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain 6 hours post-operatively: NRS	Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)	6 hours after endodontic treatment
Post-operative pain 12 hours post-operatively: NRS	Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)	12 hours after endodontic treatment
Post-operative pain 24 hours post-operatively: NRS	Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)	24 hours after endodontic treatment
Post-operative pain 48 hours post-operatively: NRS	Pain perceived by the patient using the 11-point numeric rating scale (NRS) with ranges from zero to 10 (zero meaning no pain, 1-3 means mild pain, 4-7 means moderate pain, 8-10 means severe pain with 10 being the highest pain imaginable)	48 hours after endodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in intracanal bacterial flora count	bacterial cultures made from microbiological samples taken at different stages of the endodontic treatment. The bacteria will be counted as colony forming units (CFUs). There are three samples that are taken during the endodontic treatment : S1: After Access cavity preparation. S2: After chemomechanical preparation S3: After using the intervention or control. The CFUs will be counted in the culture obtained from each sample then a comparison will be made between the intervention and control groups regarding the difference in the number of CFUs in S2 between S3	48 hours after endodontic treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Shaimaa Gawdat, PhD, central evidence based dentistry committee

Publications and helpful links

General Publications

• Dagher J, El Feghali R, Parker S, Benedicenti S, Zogheib C. Postoperative Quality of Life Following Conventional Endodontic Intracanal Irrigation Compared with Laser-Activated Irrigation: A Randomized Clinical Study. Photobiomodul Photomed Laser Surg. 2019 Apr;37(4):248-253. doi: 10.1089/photob.2018.4558.
• Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Different Irrigation Agitation Techniques on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Oct;44(10):1451-1456. doi: 10.1016/j.joen.2018.06.008. Epub 2018 Aug 23.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis
• Other Study ID Numbers: LAI_PUI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No