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

NCT05479175 | Unknown

• 1 other identifier: 12/15.12.2021
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Root canal; anesthesia; inferior alveolar nerve block

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 hours

Study Arms (4)

Ibuprofen

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Diode laser

ACTIVE COMPARATOR

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.

Device: Diode laser

Nonactive Diode laser

ACTIVE COMPARATOR

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

Device: Nonactive Diode laser

Control

NO INTERVENTION

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

Interventions

Ibuprofen DRUG

Ibuprofen

Ibuprofen

Diode laser DEVICE

Diode laser

Diode laser

Nonactive Diode laser DEVICE

Nonactive Diode laser

Nonactive Diode laser

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yıl University

Van, 65000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 21692235 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Esin Özlek, PhD

  Yuzuncu Yil University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: May 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)