Effect of Low Level Laser Therapy on Post-endodontic Pain
1 other identifier
interventional
42
1 country
1
Brief Summary
This study was designed as a randomized, placebo-controlled trial of 2 groups. The treatment procedures were performed by one operator. After local anesthesia and rubber dam isolation, access cavity preparation was performed by diamond burs with high-speed hand pieces under the water cooling. . Instrumentation of procedures was performed by Reciproc R50 files. Irrigation protocol was completed, canal were dried, filled with gutta-percha cones and AH Plus sealer. After chemo- mechanical instrumentation and root canal filling procedures, LLLT was applied for 60 second per tooth using Nd-YAG laser ( λ=1064 nm,100 mJ, 10 Hz, 1-W) The same procedures as in the laser group were performed, been completed but the laser was not activated in this group. These patients were assigned as placebo group. Postoperative pain was measured and documented via the Visual Analogue Scale. Chi-square test was performed in analysis of the nominal data.There was statistically significant difference between groups at the 12th and 24th hours (p\<.05). ). However, no statistically significant difference was found between the groups at the 4th, 8th, 48th, and 72th hours (p\>.05). No statistically significant differences were detected between the groups in terms of demographic data (age and tooth number) except for gender (P \> .05).LLLT can decrease postoperative pain after root canal treatment of single rooted teeth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Sep 2017
1 active site
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
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2018
CompletedFirst Submitted
Initial submission to the registry
November 19, 2018
CompletedFirst Posted
Study publicly available on registry
November 21, 2018
CompletedNovember 21, 2018
November 1, 2018
6 months
November 19, 2018
November 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Evaluation
Postoperative pain was measured and documented via the Visual Analogue Scale (VAS). VAS consists of a 100 mm line which is represented at one end by a sign 'No pain' and at the other end 'unbearable pain'.
3 day
Study Arms (2)
laser group
EXPERIMENTALLow level laser was applied for 60 second per tooth using Nd-YAG laser.
placebo group
PLACEBO COMPARATORThe same procedures as in the laser group were performed, been completed but the laser was not activated in this group.
Interventions
Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth
Eligibility Criteria
You may qualify if:
- Root canal treatment was planned for patients who participated in this study and have single root and single canal. Patients aged between 15 to 45 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ordu Universitylead
Study Sites (1)
Ordu University
Ordu, 52100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ELİF BAHAR ÇAKICI, ASST. PROF.
Ordu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- All procedures were conducted by one clinician , and assignment was concealed from the clinician who performed the laser applications.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant
Study Record Dates
First Submitted
November 19, 2018
First Posted
November 21, 2018
Study Start
September 1, 2017
Primary Completion
March 12, 2018
Study Completion
March 15, 2018
Last Updated
November 21, 2018
Record last verified: 2018-11