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Evaluation the Effect of Using Preoperative Ibuprofen Versus Low Level Laser Therapy on Inferior Alveolar Nerve Block

Primary Purpose

Postoperative Pain

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ibuprofen
Diode laser
Nonactive Diode laser
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Root canal, anesthesia, inferior alveolar nerve block

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy persons between the ages of 18 and 50 years
  • Mandibular molar teeth that were diagnosed with acute apical periodontitis

Exclusion Criteria:

  • Patients who are taken analgesic inflammatory drugs with in the last 12 hours
  • Pregnancy or lactation
  • Teeth with calcified canals
  • Teeth with periodontal diseases
  • Teeth with sensitive to percussion and palpation
  • Teeth with root resorption
  • Teeth with immature/open apex

Sites / Locations

  • Yuzuncu Yıl University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Ibuprofen

Diode laser

Nonactive Diode laser

Control

Arm Description

Ibuprofen 600 mg will be given to the patient one hour before starting root canal treatment.

Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds.

Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated.

Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.

Outcomes

Primary Outcome Measures

VAS Scale
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2022
Last Updated
July 28, 2022
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT05479175
Brief Title
Evaluation the Effect of Using Preoperative Ibuprofen Versus Low Level Laser Therapy on Inferior Alveolar Nerve Block
Official Title
Evaluation the Effect of Using Preoperative Ibuprofen Versus Low Level Laser Therapy on Inferior Alveolar Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

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
Acute apical periodontitis (AAP) is an inflammatory condition of the periapical tissues of the periodontium, usually resulting from irreversible pulpitis and pulpal necrosis. Patients with AAP often have moderate to severe pain, which results in the need for emergency treatment. Patients with AAP usually present with dull, throbbing, constant pain; absence of swelling; a negative or delayed positive result on vitality testing; absence of thermal sensitivity of the tooth; and pain on biting or percussion.The treatment of these teeth is root canal treatment. Pain control during root canal treatment is essential for several reasons. First, patients desire and expect that their treatment should be free of discomfort. Second, good intra-operative pain control helps to reduce post-operative pain and simplifies its management. Third, patients will be reluctant to have further root canal treatment in the future if they have had a bad experience as a result of pain during treatment. Hence, pain-free treatment should be every dentist's aim. The amount of pain experienced during treatment is related to the condition being treated teeth with irreversible pulpitis and acute apical periodontitis were significantly associated with more treatment pain than devital teeth and infected canals with apical periodontitis.In another study, molars and teeth with irreversible pulpitis had more intra-operative pain than single-rooted teeth and devital teeth, infected root canals. Local anesthesia is the most common method used for pain control during root canal treatment. However, other strategies can also be employed in some cases such as pre-treatment anti-inflammatory systemic medications, and methods to reduce discomfort associated with injections. The use of pre-operative medication reduce pain and inflammation at the treatment site. Several studies have been performed to investigate the effectiveness of this approach using a variety of drugs such as benzodiazepines, NSAIDs and corticosteroids. The concept of using NSAIDs and corticosteroids as premedication is largely based on reducing the amount of prostaglandin in the inflamed pulp. There have been conflicting results reported for the use of ibuprofen premedication with some studies reporting an increased success rate for local anaesthesia,while others have reported no effects compared with placebo. Recently, low level laser therapy has been used in dentistry for a range of treatments, including reduction of orthodontic pain, symptomatic oral lichen planus cases, healing of maxillofacial defects and prophylaxis of stomatitis. LLLT has begun to be used in endodontic treatments due to its ability to increase wound healing, its role in root canal disinfection, its role in reducing pain and its very limited side effects. However, the pain reduction mechanism of LLLT is not fully understood.
Detailed Description
The study is to be carried out in 76 medically free patients, aged 18-50 years, who were diagnosed in Van Yuzuncu Yıl University, Faculty of Dentistry, Department of Endodontic, The number of patient was calculated in the G* Power 3.1 software. In this study cohen criteria was used. Taking effect size 0.40, alpha = 0.05, and power = 0.80, the minimum number of patients was determined as 76. Lower first and second molars (36,37,46,47) diagnosed with acute apical periodontitis will be included in the study as an experimental group. Patients with periapical lesions and open apex teeth will not be included in the study group. Preoperative pain degree will be determined using Visual analogue scale (VAS) test. Patients will be randomly divided into 4 groups. Group 1: Ibuprofen 600mg will be given to the patient one hour before starting root canal treatment Group 2: Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds . Group 3: Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated. Group 4: Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure. After applying 2 ml ultracain DS forte local anesthesia access cavity will be opened. The working length will be determined using the apex locator by placing a K file #15 into the root canals until the apical constriction. The shaping process of the root canals will be done by ProTaperNext files up to the X3 as standard in all patients. 2 ml of 5.25% NaOCl irrigation solution will be applied after each file. A 2 ml dental injector with a 27 gauge dental needle will be used and The tip of the needles will be adjusted to be 2mm shorter than the working length. After complete the cleaning and shaping process, the root canals will be filled with gutta-percha and ADSEAL resin sealer using the lateral condensation technique. After complete the root canal treatment, the level of pain experienced by the patients during the treatment will be determined using the visual analogue scale (VAS) test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Root canal, anesthesia, inferior alveolar nerve block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Ibuprofen 600 mg will be given to the patient one hour before starting root canal treatment. Group 2: Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds. Group 3: Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated. Group 4: Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 600 mg will be given to the patient one hour before starting root canal treatment.
Arm Title
Diode laser
Arm Type
Active Comparator
Arm Description
Low-level laser therapy will be applied with an 810 nm wavelength diode laser device for 30 seconds in the area of mesial root and 30 seconds in the area of distal root , total of 60 seconds.
Arm Title
Nonactive Diode laser
Arm Type
Active Comparator
Arm Description
Placebo, will be explained to the patients that laser treatment will be applied as in group 2, but laser will not be activated.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control, routine root canal treatment will be done. No medication or laser will be applied before the treatment procedure.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Ibuprofen
Intervention Type
Device
Intervention Name(s)
Diode laser
Intervention Description
Diode laser
Intervention Type
Device
Intervention Name(s)
Nonactive Diode laser
Intervention Description
Nonactive Diode laser
Primary Outcome Measure Information:
Title
VAS Scale
Description
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Time Frame
up to 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy persons between the ages of 18 and 50 years Mandibular molar teeth that were diagnosed with acute apical periodontitis Exclusion Criteria: Patients who are taken analgesic inflammatory drugs with in the last 12 hours Pregnancy or lactation Teeth with calcified canals Teeth with periodontal diseases Teeth with sensitive to percussion and palpation Teeth with root resorption Teeth with immature/open apex
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esin Özlek, PhD
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Study Director
Facility Information:
Facility Name
Yuzuncu Yıl University
City
Van
ZIP/Postal Code
65000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21692235
Citation
Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
Results Reference
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Evaluation the Effect of Using Preoperative Ibuprofen Versus Low Level Laser Therapy on Inferior Alveolar Nerve Block

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