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

Dental Pain Clinical Trial

— ICLID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269406
• Other study ID #: SW008
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: September 10, 2024

Study information

• Verified date: February 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 264
• Est. completion date: September 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Removal of 2 to 4 impacted third molars

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

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
• 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

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

Locations

Country	Name	City	State
Russian Federation	Nmsi Dentmaster	Novosibirsk	Novosibirsk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	NMSI DENTMASTER

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)		8 hours
Secondary	Total pain relief (TOTPAR) %		8 hours
Secondary	Time to pain half pain gone (in minutes)		8 hours
Secondary	Duration of pain half gone (in minutes)		8 hours
Secondary	Any adverse events (facial swelling, nausea, vomiting, headache) (%)		8 hours