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

Not Applicable

Not yet recruiting

• Conditions: Dental Pain
• Interventions: Other: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure; 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

• Registration Number: NCT06269406
• Lead Sponsor: S.LAB (SOLOWAYS)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Start: 2025-03-28
• Primary Completion: 2025-07-28
• Study Completion: 2025-09-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group ibuprofen 400 and placebo	The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure	-
Intervention Group ibuprofen 400 and Curcumin	ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg	-
Intervention Group ibuprofen 200 and Curcumin	ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg	-

Primary Outcome Measures

Name	Time	Method
Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)	8 hours

Secondary Outcome Measures

Name	Time	Method
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
Total pain relief (TOTPAR) %	8 hours

Trial Locations

Locations (1)

Nmsi Dentmaster; 🇷🇺 Novosibirsk, Novosibirsk Region, Russian Federation