Laser Activated Irrigation Versus Passive Ultrasonic Irrigation

Pulp Necroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04035083
• Other study ID #: LAI_PUI
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2019
• Est. completion date: September 2021

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: Amr Ahmed, MSc
• Phone: +201224382216
• Email: dramrayman1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: September 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necroses

Intervention

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
• Passive ultrasonic irrigation
ultrasonic activation inside the canal for 1 min

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View Citation

Topçuoglu HS, Topçuoglu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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