Necrotic PulpNCT06310044
Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth
A study testing Root canal irrigant Commiphora Myrrh 50% in people with Necrotic Pulp, run by Cairo University.
Trial summary
Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Root canal irrigant Commiphora Myrrh 50%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jan 2025
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy patient (ASA I, II).
- Age between 20 and 40 years.
- Male or female.
- Patient who is able to sign and comprehend the pain scale (committed patient).
- Mandibular single rooted premolars having the following criteria:
- With single root canal.
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- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pulpal pain.
- Positive pain on percussion denoting apical periodontitis.
- Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm)
Who cannot join
- Medically compromised patients (ASA III or IV).
- Teeth with:
- Patients who could not interpret the NRS.
- Immature roots.
- Vital pulp tissues.
- Association with swelling.
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- Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- Mobility Grade II or III.
- Previously accessed or endodontically treated.
- Deep periodontal pockets more than 4 mm.
- Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
- Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
- History of intolerance to NSAIDs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Commiphora Myrrh Versus Sodium Hypochlorite as Root Canal Irrigant on Post- Operative Pain and Bacterial Load Reduction in Symptomatic Mandibular Premolar Teeth With Necrotic Pulp. (A Randomized Clinical Trial)
Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit.
Read the detailed description
The patients will be randomly divided into 2 groups. Intervention group (50% Commiphora Myrrh solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant)
Post-operative pain will be measured at 6,12,24,48 hours post-operatively The pain will be recorded using numerical rating scale
Post-operative swelling will be measured at 6,12,24,48 hours post-operatively The swelling will be receded using visual swelling rating scale
Number of analgesic tablets taken by the patient post-operatively. Up to 48 hours
Amount of bacteria load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFI /ml) before and after root canal preparation.
- Conditions
- Necrotic Pulp
- Being tested
- Root canal irrigant Commiphora Myrrh 50%
- Keywords
- Asymptomatic Necrotic Mandibular Premolar
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal irrigant Commiphora Myrrh 50%Other
Root canal irrigant
| Study group | Role | What they receive |
|---|---|---|
| Commiphora Myrrh | Experimental | 50% Commiphora Myrrh Receives: Other: Root canal irrigant Commiphora Myrrh 50% |
| Sodium hypochlorite | Active comparator | 2.5% NaOCl Receives: Other: Root canal irrigant Commiphora Myrrh 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Categorical None 0 Mild 1-3 Moderate 4-6 Sever 7-10
Measured: Post-operative pain measured at 6,12,24,48 hours after single visit Treatment
Secondary outcomes (1)
incidence of Post-operative swelling
Categorical Of visual swelling scale of post- operative
Measured: Up to 48 hours post-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahaf Abdullah khalel manzalawi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310044
- Sponsor's protocol ID
- Commiphora Myrrh
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Commiphora Myrrh Versus Sodium Hypochlorite as Root Canal Irrigant on Post- Operative Pain and Bacterial Load Reduction in Symptomatic Mandibular Premolar Teeth With Necrotic Pulp. (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06310044
- Acronym / sponsor ID
- Commiphora Myrrh
- Conditions
- Necrotic Pulp
- Keywords
- Asymptomatic Necrotic Mandibular Premolar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Mar 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.
Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit.
Detailed description
The patients will be randomly divided into 2 groups. Intervention group (50% Commiphora Myrrh solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant)
Post-operative pain will be measured at 6,12,24,48 hours post-operatively The pain will be recorded using numerical rating scale
Post-operative swelling will be measured at 6,12,24,48 hours post-operatively The swelling will be receded using visual swelling rating scale
Number of analgesic tablets taken by the patient post-operatively. Up to 48 hours
Amount of bacteria load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFI /ml) before and after root canal preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commiphora Myrrh | Experimental | Other: Root canal irrigant Commiphora Myrrh 50%50% Commiphora Myrrh |
| Sodium hypochlorite | Active comparator | Other: Root canal irrigant Commiphora Myrrh 50%2.5% NaOCl |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Systemically healthy patient (ASA I, II).
- Age between 20 and 40 years.
- Male or female.
- Patient who is able to sign and comprehend the pain scale (committed patient).
- Mandibular single rooted premolars having the following criteria:
Key exclusion criteria (13 listed)
- Medically compromised patients (ASA III or IV).
- Teeth with:
- Patients who could not interpret the NRS.
- Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
- History of intolerance to NSAIDs.
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 |
|---|---|---|
| Root canal irrigant Commiphora Myrrh 50%Root canal irrigant | Other | Commiphora Myrrh, Sodium hypochlorite |
Primary outcome
Post-operative pain
Time frame: Post-operative pain measured at 6,12,24,48 hours after single visit Treatment
Categorical None 0 Mild 1-3 Moderate 4-6 Sever 7-10
1 secondary outcome
incidence of Post-operative swelling
Time frame: Up to 48 hours post-
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: Yes
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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 study testing Root canal irrigant Commiphora Myrrh 50% in people with Necrotic Pulp, 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 10 inclusion and 13 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 13 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Rahaf A Manzalawi, BDS (01150019478 ext. +20, rahaf.manzlawi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: Post-operative pain measured at 6,12,24,48 hours after single visit Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.