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
1 other identifier
interventional
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJuly 30, 2019
July 1, 2019
1.3 years
July 19, 2019
July 26, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
change in intracanal bacterial flora count
48 hours after endodontic treatment
Study Arms (2)
Laser activated irrigation
EXPERIMENTALLaser activated irrigation of sodium hypochlorite using a 980 nm diode laser device
Passive ultrasonic irrigation
ACTIVE COMPARATORpassive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device
Interventions
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
ultrasonic activation inside the canal for 1 min
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related 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.
PMID: 31050955BACKGROUNDTopcuoglu 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.
PMID: 30144989BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shaimaa Gawdat, PhD
central evidence based dentistry committee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer
Study Record Dates
First Submitted
July 19, 2019
First Posted
July 29, 2019
Study Start
September 1, 2019
Primary Completion
January 1, 2021
Study Completion
September 1, 2021
Last Updated
July 30, 2019
Record last verified: 2019-07