Clinical trial NCT06439212: the Efficacy of Ginger Powder as an Analgesic for Intraoperative and Post- Endodontic Pain Management
Official title: Assessing the Efficacy of Ginger Powder Capsules as an Analgesic for Intraoperative and Post- Endodontic Pain Management in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Endodontic Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the analgesic effect of ginger powder capsules compared to placebo on intra-operative and post-operative pain of single-visit endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.

Detailed description: The pharmacological pain management usually includes administration of systemic analgesics, anti-inflammatory drugs, or antibiotics drugs. The inhibition of the inflammatory process is one of the methods to reduce or prevent pain during and after treatment.

Ginger has a lengthy history of use as a herbal medicine. Ginger has been used in traditional Chinese and Indian medicine to treat a variety of diseases, including arthritis, stomachaches, diarrhea, nausea, asthma, and respiratory problems. It was discovered that ginger also contains substances that prevent PG production. This discovery gave its anti-inflammatory benefits a solid scientific justification. Following research, it was discovered that some of the components of ginger share pharmacological traits with a novel family of dual-acting NSAIDs. These substances have significantly fewer adverse effects than traditional NSAIDs and can inhibit arachidonic acid metabolism via both the cyclooxygenase (COX) and lipoxygenase (LOX) pathways.

Various animal studies have shown that taking dried ginger or ginger extract orally can decrease acute inflammation. Numerous clinical studies back up the effectiveness of ginger in treating osteoarthritis, and in some instances, a noticeable decrease in knee pain has been reported. In some of these studies, it was discovered that ginger, even when used for extended amounts of time, significantly reduced pain and swelling in patients with osteoarthritis, rheumatoid arthritis, and muscular pain.

There have been no studies done to evaluate the impact of ginger powder on intra and post-endodontic pain. In order to find the effects of ginger powder capsules on pain after endodontic treatment, the current study was performed.

Eligibility criteria: Inclusion Criteria:

1. Patients aging between 18-45 years old.
2. Patients with mandibular molar with signs and symptoms of symptomatic irreversible pulpitis.
3. Systemically- healthy patients (ASA I or II).
4. Patients who agree to attend for recall appointments.
5. Patients who can understand pain scale and can sign the informed consent.

Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Patients allergic to ginger, articaine or any other medicament material used in the study.
3. History of peptic ulceration.
4. Periapical abscess or fistula.
5. Non-restorable teeth.
6. Moderate or severe marginal periodontitis i.e. pocket probe\>3mm.
7. Patients on Aspirin, Clopidogrel, Dalteparin and Warfarin.
8. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Primary outcomes:
measure: Postoperative pain
timeFrame: Pain will be assessed at 6 hours, 12 hours, 24 hours and 48 hours postoperatively
Secondary outcomes:
measure: Intraoperative pain
timeFrame: Pain will be assessed during the procedure
measure: Rescue-analgesic intake by the patient after endodontic treatment.
timeFrame: Taken after 48 hours post-operatively
Other outcomes:
Locations:
Study officials:
References:
citation: Menon P, Perayil J, Fenol A, Rajan Peter M, Lakshmi P, Suresh R. Effectiveness of ginger on pain following periodontal surgery - A randomized cross-over clinical trial. J Ayurveda Integr Med. 2021 Jan-Mar;12(1):65-69. doi: 10.1016/j.jaim.2020.05.003. Epub 2020 Jul 2.
citation: Rayati F, Hajmanouchehri F, Najafi E. Comparison of anti-inflammatory and analgesic effects of Ginger powder and Ibuprofen in postsurgical pain model: A randomized, double-blind, case-control clinical trial. Dent Res J (Isfahan). 2017 Jan-Feb;14(1):1-7. doi: 10.4103/1735-3327.201135.
citation: Alshibani N, Al-Kattan R, Alssum L, Basudan A, Shaheen M, Alqutub MN, Al Dahash F. Postoperative Analgesic and Anti-inflammatory Effectiveness of Ginger (Zingiber officinale) and NSAIDs as Adjuncts to Nonsurgical Periodontal Therapy for the Management of Periodontitis. Oral Health Prev Dent. 2022 Jul 13;20:227-232. doi: 10.3290/j.ohpd.b3125633.