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

NCT06269406 | Not Yet Recruiting

• 1 other identifier: SW008
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Pain

Keywords

Postoperative Dental Pain; Curcumin and Licorice Root; Ibuprofen; Anti-inflammatory Properties; molars

Outcome Measures

Primary Outcomes (1)

• Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)

  8 hours

Secondary Outcomes (4)

• 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

Study Arms (3)

Intervention Group ibuprofen 400 and Curcumin

EXPERIMENTAL

Dietary Supplement: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg

Intervention Group ibuprofen 200 and Curcumin

EXPERIMENTAL

Dietary Supplement: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg

Intervention Group ibuprofen 400 and placebo

PLACEBO COMPARATOR

Other: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure

Interventions

ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg DIETARY_SUPPLEMENT

The combination of ibuprofen 400 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure

Intervention Group ibuprofen 400 and Curcumin

ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg DIETARY_SUPPLEMENT

The combination of ibuprofen 200 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure

Intervention Group ibuprofen 200 and Curcumin

The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure OTHER

The combination of ibuprofen 400 mg and placebo 100 mg in patients after 2-4 molars procedure

Intervention Group ibuprofen 400 and placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Removal of 2 to 4 impacted third molars

You may not qualify if:

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

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• NMSI DENTMASTER: collaborator

Study Sites (1)

Nmsi Dentmaster

Novosibirsk, Novosibirsk Oblast, 630090, Russia

Location

MeSH Terms

Conditions

Toothache

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 21, 2024
• Study Start: July 28, 2025
• Primary Completion: July 28, 2025
• Study Completion: September 28, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

RU (1)