Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06269406
Other study ID # SW008
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00943098 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery Phase 3
Completed NCT00985439 - Study of Diclofenac Capsules to Treat Dental Pain Phase 2
Completed NCT00942448 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery Phase 3
Completed NCT00954356 - Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction Phase 2
Completed NCT02966067 - A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery N/A
Completed NCT01960114 - Study of Long-Acting Acetaminophen in Postoperative Dental Pain Phase 2
Completed NCT01229228 - Study of Naproxen Capsules to Treat Dental Pain Phase 2
Completed NCT01177423 - Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block N/A
Completed NCT03328208 - Nonpharmacologic Reduction of Periprocedural Distress and Drug Use N/A
Completed NCT05236101 - Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety N/A
Completed NCT00542035 - A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction Phase 2
Completed NCT04231955 - Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth N/A
Completed NCT02096926 - Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery Phase 4
Completed NCT05369936 - Pain Perception: on Relationships Between Dental Anxiety and Olfaction N/A
Recruiting NCT05351099 - Dental Block for Pain Relief in ED Dental Pain Patients
Recruiting NCT05443009 - Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction Phase 4
Terminated NCT02161354 - Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars Phase 2
Completed NCT04949126 - Self Medication in Odontology (AUDE)
Completed NCT03652818 - Dental Pain Study of Analgesics in Patients Undergoing Molar Removal Phase 2
Withdrawn NCT05194449 - Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry N/A