the Efficacy of Ginger Powder as an Analgesic for Intraoperative and Post- Endodontic Pain Management

NCT ID: NCT06439212

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endodontic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ginger

Choosing ginger as a pain analgesic is significant due to its anti-inflammatory properties. The presence of active compounds, like shogaols, suggests ginger could provide a clinically effective and safer alternative in managing intra-operative and post-endodontic pain.

Patient will receive one capsule of 500mg ginger powder capsule thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.

Group Type EXPERIMENTAL

Ginger powder capsule

Intervention Type DRUG

Patient will receive one capsule of 500mg ginger powder capsule thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.

Placebo

Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ginger powder capsule

Patient will receive one capsule of 500mg ginger powder capsule thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.

Intervention Type DRUG

Placebo

Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omar Alderbashi

Master degree student - Department of Endodontics - Faculty of Dentistry - Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omar M Alderbashi, Bachelor

Role: CONTACT

00201126831502

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32624375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28348610 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35695692 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ginger as an Analgesic for EPM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Post-operative Pain Reduction
NCT04338633 UNKNOWN NA
Premedication on Post-endodontic Pain
NCT06671743 RECRUITING PHASE3