- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07932340
Effect of Turmeric Extract With Black Pepper on Tooth Pain After Root Canal Treatment
EFFECT OF PREOPERATIVE ORAL CURCUMIN WITH PIPERINE ON POSTOPERATIVE PAIN FOLLOWING SINGLE-VISIT PRIMARY ROOT CANAL TREATMENT IN MANDIBULAR MOLARS WITH SYMPTOMATIC IRREVERSIBLE PULPITIS
The purpose of this study is to evaluate the effectiveness of taking a turmeric extract supplement before a root canal to help reduce tooth pain after the procedure.
Patients diagnosed with symptomatic irreversible pulpitis (severe, irreversible tooth nerve inflammation causing significant pain) in their lower back teeth (mandibular molars) will participate in the study. All participants will receive a standard, single visit root canal treatment. Before the procedure begins, one group of patients will receive an oral supplement containing curcumin (the active compound in turmeric) combined with piperine (black pepper extract, which helps the body absorb curcumin). Another group will receive a placebo (an inactive substance).
The investigators will compare the levels of postoperative pain between the two groups in the days following the root canal treatment to see if the turmeric extract supplement successfully provides better pain relief.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Zonash Rashid, BDS
- Telefonnummer: 00923208899790
- E-post: zonashrashid005@gmail.com
Studiesteder
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan
- Watim Medical & Dental College
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Ta kontakt med:
- Zonash Rashid, BDS
- Telefonnummer: 00923208899790
- E-post: zonashrashid005@gmail.com
-
Ta kontakt med:
- E-post: zonashrashid005@gmail.com
-
Hovedetterforsker:
- Zonash Rashid, BDS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients aged 18 to 60 years.
- Mature permanent mandibular first or second molar with clinical diagnosis of symptomatic irreversible pulpitis.
- Moderate to severe preoperative pain on the VAS.
- Willingness to provide written informed consent and complete the 48-hour pain record.
Exclusion Criteria:
- Pregnancy or lactation.
- Known hypersensitivity to curcumin, turmeric or capsule components.
- Analgesic or anti-inflammatory medication within 12 hours before treatment.
- Anticoagulant or antiplatelet therapy, clinically relevant bleeding disorder, or significant hepatic, renal or gastrointestinal disease.
- Acute apical abscess, swelling, sinus tract or radiographic apical periodontitis.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placeboarm
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An inactive capsule manufactured to be completely identical in appearance, color, size, and weight to the active curcumin capsule, administered preoperatively. |
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Eksperimentell: Curcumin Arm
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An oral administration consisting of curcumin paired with piperine, administered preoperatively to enhance bioavailability prior to the root canal treatment. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Score
Tidsramme: 24 Hours
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Postoperative pain will be assessed using a 0-100 mm Visual Analog Scale (VAS), where a score of 0 mm represents "no pain" and a score of 100 mm represents "the worst possible pain." Patients will mark their pain level on a 100 mm line, and higher scores indicate a greater intensity of postoperative pain. |
24 Hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rescue Analgesic Consumption
Tidsramme: Up to 48 hours post-treatment
|
The total amount of rescue medication taken by the participants will be recorded. Patients will be instructed to take Ibuprofen as needed for severe postoperative pain. The outcome will be measured as the average number of Ibuprofen tablets consumed per participant during the follow up period. A lower tablet count indicates better pain management by the preoperative intervention. |
Up to 48 hours post-treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Pak JG, White SN. Pain prevalence and severity before, during, and after root canal treatment: a systematic review. J Endod. 2011 Apr;37(4):429-38. doi: 10.1016/j.joen.2010.12.016.
- Shoba G, Joy D, Joseph T, Majeed M, Rajendran R, Srinivas PS. Influence of piperine on the pharmacokinetics of curcumin in animals and human volunteers. Planta Med. 1998 May;64(4):353-6. doi: 10.1055/s-2006-957450.
- Lopresti AL, Smith SJ, Hood SD, et al. Efficacy of curcumin plus piperine co-supplementation in pain management: a systematic review and meta-analysis. Front Nutr. 2024;11:1348329.
- Singhal R, Agarwal A, Rastogi P, et al. Current applications of Curcuma longa in dentistry: a scoping review of literature published after 2019. BMC Oral Health. 2026;26(1):45-58.
- Reddy MS, Ramachandra SS, Shetty SR, Khazi SS, Ur Rahman Tippu MS, Narayanan LA, Shetty RM, Azim SA, Ramana VV, Al-Bayati SAAF, Razooki A, Fouad NN. Analgesic Efficacy of Phytotherapeutic Agents in Dental Pain Management: A Systematic Review. Int J Dent. 2025 Nov 20;2025:5614623. doi: 10.1155/ijod/5614623. eCollection 2025.
- Bucevic Popovic V, Karahmet Farhat E, Banjari I, Jelicic Kadic A, Puljak L. Bioavailability of Oral Curcumin in Systematic Reviews: A Methodological Study. Pharmaceuticals (Basel). 2024 Jan 28;17(2):164. doi: 10.3390/ph17020164.
- Di Cosola M, Cazzolla AP, Charitos IA, et al. The role of curcumin in oral health and diseases: a systematic review. Dent J (Basel). 2024;12(5):132.
- Hashemi N, Shahsavari F, Mokhtari H, et al. Analgesic effect of a kind of herbal medicine, compared to ibuprofen on post-endodontic pain: a randomized clinical trial study. J Mashhad Dent Sch. 2023;47(3):337-345.
- Abdelnaby MS, Eid GEM, El Nabarawi MA. The effect of premedication with curcumin on post-operative pain in single visit endodontic treatment of acute pulpitis in mandibular molars: a randomized controlled trial. J Dent Oral Epidemiol. 2021;1(3):1-11.
- Khan MK, Khan IA, Liaquat A. Therapeutic Potential of Curcumin with and without Strengthening Exercises in Improving Rheumatoid Arthritis. J Coll Physicians Surg Pak. 2022 Dec;32(12):1640-1643. doi: 10.29271/jcpsp.2022.12.1640.
- Singla R, Gupta C, Gill GS, Jain N, Arora S, Algarni YA, Kader MA, Cicciu M, Minervini G. Effect of Curcuma longa (Turmeric), as an intra-canal medicament, on inter-appointment endodontic pain in patients with symptomatic irreversible pulpitis: A randomized controlled clinical trial. Heliyon. 2024 Jun 28;10(14):e33797. doi: 10.1016/j.heliyon.2024.e33797. eCollection 2024 Jul 30.
- Basu P, Maier C, Basu A. Effects of Curcumin and Its Different Formulations in Preclinical and Clinical Studies of Peripheral Neuropathic and Postoperative Pain: A Comprehensive Review. Int J Mol Sci. 2021 Apr 28;22(9):4666. doi: 10.3390/ijms22094666.
- De Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. Effects of Ibuprofen Compared to Other Premedication Drugs on the Risk and Intensity of Postendodontic Pain: A Systematic Review. Eur Endod J. 2018 Oct 9;3(3):123-133. doi: 10.14744/eej.2018.83803. eCollection 2018.
- Elkhadem A, Ezzat K, Ramadan M, AbdelGhaffar S, Khamis D, Hassan A, Abdel-Mawgoud A, Mamdouh A, AbouZeid M, Amin S. The effect of preoperative oral administration of prednisolone on postoperative pain in patients with symptomatic irreversible pulpitis: a single-centre randomized controlled trial. Int Endod J. 2018 Apr;51 Suppl 3:e189-e196. doi: 10.1111/iej.12795. Epub 2017 Jul 4.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Smerte
- Nevrologiske manifestasjoner
- Postoperative komplikasjoner
- Patologiske prosesser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Smerter, postoperativt
- Organiske kjemikalier
- Hydrokarboner, acyklisk
- Hydrokarboner
- Hydrokarboner, syklisk
- Hydrokarboner, aromatisk
- Diarlheptanoider
- Heptanes
- Alkaner
- Katekoler
- Fenoler
- Benzenderivater
- Curcumin
- Piperine
Andre studie-ID-numre
- WM&DCR/R&D(IERB)/2026/273
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
he individual participant data will not be shared outside the host institution to maintain patient confidentiality and comply with institutional privacy protocols.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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