Menu
Not yet recruiting NCT06269406

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

No phase Interventional Dental Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg, ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg, The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure.
Who it may be relevant to
Registry conditions: Dental Pain. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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
  • 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
  • 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

Primary outcome measures

  • Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points) [Time frame: 8 hours]
Secondary outcome measures (4)
  • Total pain relief (TOTPAR) % [Time frame: 8 hours]
  • Time to pain half pain gone (in minutes) [Time frame: 8 hours]
  • Duration of pain half gone (in minutes) [Time frame: 8 hours]
  • Any adverse events (facial swelling, nausea, vomiting, headache) (%) [Time frame: 8 hours]

Eligibility criteria

Inclusion criteria

  • Removal of 2 to 4 impacted third molars

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • Nmsi Dentmaster — Novosibirsk

Identifiers

NCT: NCT06269406 · SW008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗