A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults (ICLID)

A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults, Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Study

Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Pain
• Intervention / Treatment: Dietary supplement: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg; Dietary supplement: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg; Other: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk Region
    • Novosibirsk, Novosibirsk Region, Russian Federation, 630090
      • Nmsi Dentmaster
      • Contact: Gatilova A Tatyana, MD; Phone Number: +7 9529399919

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Removal of 2 to 4 impacted third molars

Exclusion Criteria:

• Pregnancy or breastfeeding
• Ibuprofen contraindications.
• Allergy to any of the intervention components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group ibuprofen 400 and Curcumin	Dietary supplement: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg; The combination of ibuprofen 400 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure
Experimental: Intervention Group ibuprofen 200 and Curcumin	Dietary supplement: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg; The combination of ibuprofen 200 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure
Placebo Comparator: Intervention Group ibuprofen 400 and placebo	Other: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure; The combination of ibuprofen 400 mg and placebo 100 mg in patients after 2-4 molars procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)	8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Total pain relief (TOTPAR) %	8 hours
Time to pain half pain gone (in minutes)	8 hours
Duration of pain half gone (in minutes)	8 hours
Any adverse events (facial swelling, nausea, vomiting, headache) (%)	8 hours

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: NMSI DENTMASTER

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2024
• Primary Completion (Estimated): July 10, 2024
• Study Completion (Estimated): September 10, 2024

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ibuprofen; molars; Postoperative Dental Pain; Curcumin and Licorice Root; Anti-inflammatory Properties
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Ibuprofen; Curcumin
• Other Study ID Numbers: SW008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No