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

ConditionDental Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorS.LAB (SOLOWAYS)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Removal of 2 to 4 impacted third molars

Disqualifiers

Pregnancy or breastfeeding

Ibuprofen contraindications.

Allergy to any of the intervention components.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

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

    Other intervention

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

Treatment groups

264 Participants
are divided into 3 treatment groups
Group A: Intervention Group ibuprofen 400 and CurcuminExperimental treatment 1 intervention
Group B: Intervention Group ibuprofen 200 and CurcuminExperimental treatment 1 intervention
Group C: Intervention Group ibuprofen 400 and placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 hours

Secondary outcomes

1

Total pain relief (TOTPAR) %

Time frame
8 hours
2

Time to pain half pain gone (in minutes)

Time frame
8 hours
3

Duration of pain half gone (in minutes)

Time frame
8 hours
4

Any adverse events (facial swelling, nausea, vomiting, headache) (%)

Time frame
8 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

S.LAB (SOLOWAYS)

Lead sponsor

NMSI DENTMASTER

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: