search
Back to results

Effect of Low Level Laser Therapy on Post-endodontic Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laser
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring laser, pulpitis, pain

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Exclusion criteria related with teeth were swelling or sinus tract, acute pain, periodontal probing greater than 3mm, internal and external resorption, fractured and cracked tooth, percussion sensitivity, and periapical index classification 3, 4, 5 according to Orstavik et al. (1986).
  • Exclusion criteria related with systemic health of patients included diabetes, hypertension and cardiovascular pathologies, the use of analgesics and / or antibiotics at least one week before treatment, and using antidepressant drugs.

Sites / Locations

  • Ordu University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

laser group

placebo group

Arm Description

Low level laser was applied for 60 second per tooth using Nd-YAG laser.

The same procedures as in the laser group were performed, been completed but the laser was not activated in this group.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2018
Last Updated
November 19, 2018
Sponsor
T.C. ORDU ÜNİVERSİTESİ
search

1. Study Identification

Unique Protocol Identification Number
NCT03748498
Brief Title
Effect of Low Level Laser Therapy on Post-endodontic Pain
Official Title
Effect of Low Level Laser Therapy on Postoperative Pain After Single Visit Endodontic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study was approved by the local ethics committee ....................., and informed consent was received from all participants. Study subjects were selected among patients who presented to the Department of Endodontics, Faculty of Dentistry ........................from September 2017 to March 2018. 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. Exclusion criteria related with teeth were swelling or sinus tract, acute pain, periodontal probing greater than 3mm, internal and external resorption, fractured and cracked tooth, percussion sensitivity, and periapical index classification 3, 4, 5 according to Orstavik et al. (1986). Exclusion criteria related with systemic health of patients included diabetes, hypertension and cardiovascular pathologies, the use of analgesics and / or antibiotics at least one week before treatment, and using antidepressant drugs.The treatment procedures were performed by one operator (G.A.). Initially, patients' age, gender, and tooth number were recorded by the operator. 1.5 mL 2% articaine with 0.012 mg epinephrine (Ultracaine DS Forte; Aventis, Istanbul, Turkey) was used as local anesthetic. After rubber dam isolation, access cavity preparation was performed by diamond burs (ADIA Dental Burs, Turkey) with high-speed hand pieces under the water cooling. A #10 K- type (Kerr Corporation, Orange, CA) file was inserted to root canal to determine working length using an apex locator (Raypex, VDW). Working length was set as 1 mm shorter than the apical foramen and confirmed with periapical radiographs. Instrumentation of procedures was performed by Reciproc R50 files (VDW, Munich, Germany). Irrigation protocol was completed 5 mL 17% EDTA (Werax, Turkey) and 15 mL 2.5% sodium hypochlorite (NaOCl)(Wizard, Turkey ) with a side-vented needle (NaviTip needle; Ultradent Products Inc, South Jordan, UT). Subsequently, canal were dried with paper points and filled with gutta-percha cones and AH Plus sealer (Dentsply Maillefer). Lateral cold condensation technique was used for obturation. Finally, coronal access cavity was restored with a temporary restorative material (Cavit G; 3M ESPE, St Paul, MN). Permanent restoration was completed after the end of the experiment.A randomization was produced using through a website (http://www.random.org), after the clinician (G.A.) was completed all treatment procedures. All procedures were conducted by one clinician (C.E.B.), and assignment was concealed from the clinician who performed the laser applications (U.B.). Data analysis and interpretation were completed by the other researcher (C.F.) 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[Deka smart file, DEKA, Italy]). Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth. An application biostimulation tip was used to ensure a constant distance of 10 mm to the tissue.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 (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'. This form was given to the each patient and they were instructed to mark according to the pain intensity at 4th, 8th, 12th, 24th, 48th and 72th hours.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). Aside from sex, No statistically significant differences were detected between the groups in terms of demographic data (age and tooth number) except for gender (P > .05). During in this study, no patient reported swelling, sinus tract, palpation pain and didn't need analgesics both in groups.Within the limitations of the present study, LLLT can decrease postoperative pain after root canal treatment of single rooted teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laser, pulpitis, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study was designed as a randomized, placebo-controlled trial of 2 groups.
Masking
Investigator
Masking Description
All procedures were conducted by one clinician , and assignment was concealed from the clinician who performed the laser applications.
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laser group
Arm Type
Experimental
Arm Description
Low level laser was applied for 60 second per tooth using Nd-YAG laser.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
The same procedures as in the laser group were performed, been completed but the laser was not activated in this group.
Intervention Type
Device
Intervention Name(s)
laser
Intervention Description
Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth
Primary Outcome Measure Information:
Title
Pain Evaluation
Description
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'.
Time Frame
3 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Exclusion criteria related with teeth were swelling or sinus tract, acute pain, periodontal probing greater than 3mm, internal and external resorption, fractured and cracked tooth, percussion sensitivity, and periapical index classification 3, 4, 5 according to Orstavik et al. (1986). Exclusion criteria related with systemic health of patients included diabetes, hypertension and cardiovascular pathologies, the use of analgesics and / or antibiotics at least one week before treatment, and using antidepressant drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ELİF BAHAR ÇAKICI, ASST. PROF.
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordu University
City
Ordu
ZIP/Postal Code
52100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Low Level Laser Therapy on Post-endodontic Pain

We'll reach out to this number within 24 hrs