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

Phase 3

Not yet recruiting

• Conditions: Endodontic Disease
• Interventions: Drug: Placebo; Drug: Ginger powder capsule

• Registration Number: NCT06439212
• Lead Sponsor: Cairo University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-18
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Study Start: 2024-06-15
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.
Ginger	Ginger powder capsule	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	Pain will be assessed at 6 hours, 12 hours, 24 hours and 48 hours postoperatively	Pain will be assessed using Heft-Parker visual analog scale (HP-VAS). HP-VAS is an 170 mm scale consisting of numbers from 0 to 170. 0 readings represent "no pain"; 1- 54 readings represent "mild pain" 55 - 114 readings represent "moderate pain" 115 - 170 readings represent "severe pain" No to mild pain will be considered as effective medication while moderate to severe pain will be regarded as not effective medication.

Secondary Outcome Measures

Name	Time	Method
Intraoperative pain	Pain will be assessed during the procedure	Pain will be assessed using Heft-Parker visual analog scale (HP-VAS). HP-VAS is an 170 mm scale consisting of numbers from 0 to 170. 0 readings represent "no pain"; 1- 54 readings represent "mild pain" 55 - 114 readings represent "moderate pain" 115 - 170 readings represent "severe pain" No to mild pain will be considered as effective medication while moderate to severe pain will be regarded as not effective medication.
Rescue-analgesic intake by the patient after endodontic treatment.	Taken after 48 hours post-operatively	The patient will be asked if they needed a rescue analgesic or not, when and how many times.