Laser Activated Irrigation Versus Passive Ultrasonic Irrigation
Primary Purpose
Pulp Necroses
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser activated irrigation
Passive ultrasonic irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Necroses
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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser activated irrigation
Passive ultrasonic irrigation
Arm Description
Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device
passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04035083
Brief Title
Laser Activated Irrigation Versus Passive Ultrasonic Irrigation
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necroses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser activated irrigation
Arm Type
Experimental
Arm Description
Laser activated irrigation of sodium hypochlorite using a 980 nm diode laser device
Arm Title
Passive ultrasonic irrigation
Arm Type
Active Comparator
Arm Description
passive ultrasonic irrigation of sodium hypochlorite using an ultrasonic laser device
Intervention Type
Device
Intervention Name(s)
Laser activated irrigation
Intervention Description
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
Intervention Name(s)
Passive ultrasonic irrigation
Intervention Description
ultrasonic activation inside the canal for 1 min
Primary Outcome Measure Information:
Title
Post-operative pain 6 hours post-operatively: NRS
Description
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)
Time Frame
6 hours after endodontic treatment
Title
Post-operative pain 12 hours post-operatively: NRS
Description
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)
Time Frame
12 hours after endodontic treatment
Title
Post-operative pain 24 hours post-operatively: NRS
Description
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)
Time Frame
24 hours after endodontic treatment
Title
Post-operative pain 48 hours post-operatively: NRS
Description
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)
Time Frame
48 hours after endodontic treatment
Secondary Outcome Measure Information:
Title
change in intracanal bacterial flora count
Description
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
Time Frame
48 hours after endodontic treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Ahmed, MSc
Phone
+201224382216
Email
dramrayman1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaimaa Gawdat, PhD
Organizational Affiliation
central evidence based dentistry committee
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31050955
Citation
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.
Results Reference
background
PubMed Identifier
30144989
Citation
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.
Results Reference
background
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Laser Activated Irrigation Versus Passive Ultrasonic Irrigation
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