Laser Activated Irrigation Versus Passive Ultrasonic Irrigation

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Pulp Necroses

Intervention / Treatment
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* Device: Laser activated irrigation
* Device: Passive ultrasonic irrigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser activated irrigation<br>Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device | Device: Laser activated irrigation<br>* 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<br>|
| Active Comparator: Passive ultrasonic irrigation<br>passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device | Device: Passive ultrasonic irrigation<br>* ultrasonic activation inside the canal for 1 min<br>|

What is the study measuring?
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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 |