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

NCT06439212 | Not Yet Recruiting Phase 3

• 1 other identifier: Ginger as an Analgesic for EPM
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  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.

  Pain will be assessed at 6 hours, 12 hours, 24 hours and 48 hours postoperatively

Secondary Outcomes (2)

• Intraoperative pain

  Pain will be assessed during the procedure

• Rescue-analgesic intake by the patient after endodontic treatment.

  Taken after 48 hours post-operatively

Study Arms (2)

Ginger

EXPERIMENTAL

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.

Drug: Ginger powder capsule

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ginger powder capsule 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.

Ginger

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (3)

• 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.

  PMID: 32624375 BACKGROUND

• 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.

  PMID: 28348610 BACKGROUND

• 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.

  PMID: 35695692 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Omar M Alderbashi, Bachelor

CONTACT

00201126831502; omar-ibrahim@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree student - Department of Endodontics - Faculty of Dentistry - Cairo University

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: June 3, 2024
• Study Start: June 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-05