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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
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

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
Primary Outcome Measures
NameTimeMethod
Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)8 hours
Secondary Outcome Measures
NameTimeMethod
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

Nmsi Dentmaster
🇷🇺Novosibirsk, Novosibirsk Region, Russian Federation
Gatilova A Tatyana, MD
Contact
9529399919

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