Laser Activated Irrigation Versus Passive Ultrasonic Irrigation

NCT ID: NCT04035083

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2021-09-30

Brief Summary

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.

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

Conditions

Pulp Necroses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laser activated irrigation

Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device

Group Type: EXPERIMENTAL

Laser activated irrigation

Intervention Type: DEVICE

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

Passive ultrasonic irrigation

passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device

Group Type: ACTIVE_COMPARATOR

Passive ultrasonic irrigation

Intervention Type: DEVICE

ultrasonic activation inside the canal for 1 min

Interventions

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

Intervention Type: DEVICE

Passive ultrasonic irrigation

ultrasonic activation inside the canal for 1 min

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Ayman Abo El Enin Ahmed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaimaa Gawdat, PhD

Role: STUDY_DIRECTOR

central evidence based dentistry committee

Central Contacts

Amr Ahmed, MSc

Role: CONTACT

dramrayman1@gmail.com

+201224382216

References

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.

Reference Type: BACKGROUND

PMID: 31050955 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30144989 (View on PubMed)

Other Identifiers

LAI_PUI

Identifier Type: -

Identifier Source: org_study_id