Endodontic DiseasePhase 3NCT06439212
the Efficacy of Ginger Powder as an Analgesic for Intraoperative and Post- Endodontic Pain Management
A Phase 3 study testing Ginger powder capsule in people with Endodontic Disease, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Ginger powder capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 1 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Endodontic Disease
- Being tested
- Ginger powder capsule, Placebo
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger powder capsuleDrug
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.
PlaceboDrug
Patient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pain will be assessed at 6 hours, 12 hours, 24 hours and 48 hours postoperatively
Secondary outcomes (2)
Intraoperative 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.
Measured: Pain will be assessed during the procedure
Rescue-analgesic intake by the patient after endodontic treatment.
The patient will be asked if they needed a rescue analgesic or not, when and how many times.
Measured: Taken after 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alderbashi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439212
- Sponsor's protocol ID
- Ginger as an Analgesic for EPM
- Status last verified
- May 2024
- First submitted
- 18 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32624375Rayati 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.
PubMed 28348610Alshibani 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.
PubMed 35695692
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06439212
- Acronym / sponsor ID
- Ginger as an Analgesic for EPM
- Conditions
- Endodontic Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Experimental | Drug: Ginger powder capsuleChoosing 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger powder capsulePatient 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 |
| PlaceboPatient will receive one capsule of placebo thrice daily for two days. First dose will be administered 1 hour before starting endodontic treatment. | Drug | Placebo |
Primary outcome
Postoperative pain
Time frame: 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.
2 secondary outcomes
Intraoperative pain
Time frame: Pain will be assessed during the procedure
Rescue-analgesic intake by the patient after endodontic treatment.
Time frame: Taken after 48 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Background: PubMed 32624375Menon 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.
- Background: PubMed 28348610Rayati 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.
- Background: PubMed 35695692Alshibani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ginger powder capsule in people with Endodontic Disease, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar M Alderbashi, Bachelor (00201126831502, omar-ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Pain will be assessed at 6 hours, 12 hours, 24 hours and 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439212, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.