Necrotic PulpNCT05289843
Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants
A study testing Rosmarinus Officinallis in people with Necrotic Pulp, run by Cairo University.
Trial summary
To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Rosmarinus Officinallis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Jul 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systematically healthy patient (ASA I and II).
- Age between 20 and 45 years with no sex predilection
- Mandibular permanent premolar teeth:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain.
- Radiographic evidence of root and root canal.
Show all 10Show fewer
- Slight widening in the periodontal membrane space or with periapical radiolucency.
- No response to cold pulp tester (ethyl chloride spray)
- Patients who can understand and interpret Numerical rating scale (NRS).
- Patients' acceptance to participate in the trial
Who cannot join
- 1- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- 2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- 4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
- Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
- Immature teeth.
- 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: Effect of Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Bacterial Reduction in Asymptomatic Necrotic Mandibular Premolars
To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.
- Conditions
- Necrotic Pulp
- Being tested
- Rosmarinus Officinallis
- 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.
Rosmarinus OfficinallisOther
Root canal Irrigants
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Rosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars. Receives: Other: Rosmarinus Officinallis |
| Control Group | No intervention | Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after root canal treatment.
The patient is asked to grade his degree of pain on the Numerical Rating Scale (NRS) chart which is an 11 points scale consisting of numbers from 0 to 10, where zero reading represents no pain , 1-3 readings represent mild pain, 4-6 readings represent moderate pain. 7-10 readings represent severe pain .
Measured: Up to 48 hours postoperative.
Secondary outcomes (1)
Intracanal bacterial load change.
The intracanal bacterial load change is calculated through using colony forming units per milliliter test before and after root canal preparation.
Measured: First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study startMay 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (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, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayah Tarek El Sayed Abudlaah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289843
- Sponsor's protocol ID
- ENDO 3-7-2
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosmarinus Officinalis Versus 2.5%Sodium Hypochlorite as Root Canal Irrigants on the Intensity of Post-operative Pain and Bacterial Reduction in Asymptomatic Necrotic Mandibular Premolars
- ClinicalTrials.gov ID
- NCT05289843
- Acronym / sponsor ID
- ENDO 3-7-2
- Conditions
- Necrotic Pulp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 22 Mar 2022 (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.
To measure the Effect of Rosmarinus Officinalis versus 2.5%Sodium Hypochlorite as Root canal Irrigants on the Intensity of post-operative pain and Bacterial Reduction in asymptomatic necrotic Mandibular premolars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Rosmarinus OfficinallisRosmarinus officinals will be used as root canal irrigant in treating aysymptomatic mandibular premolars. |
| Control Group | No intervention | –Sodium Hypochlorite used as control in root canal irrigations in treating a asymptomatic mandibular premoalrs. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Systematically healthy patient (ASA I and II).
- Age between 20 and 45 years with no sex predilection
- Mandibular permanent premolar teeth:
- Patients who can understand and interpret Numerical rating scale (NRS).
- Patients' acceptance to participate in the trial
Key exclusion criteria (6 listed)
- 1- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- 2- History of intolerance to NSAIDS. 3- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- 4- Pregnant women: Avoid radiation exposure, anesthesia, and medication. 5- Teeth with: i. Vital teeth. ii. Double canal mandibular premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
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 |
|---|---|---|
| Rosmarinus OfficinallisRoot canal Irrigants | Other | Experimental |
Primary outcome
Postoperative pain after root canal treatment.
Time frame: Up to 48 hours postoperative.
The patient is asked to grade his degree of pain on the Numerical Rating Scale (NRS) chart which is an 11 points scale consisting of numbers from 0 to 10, where zero reading represents no pain , 1-3 readings represent mild pain, 4-6 readings represent moderate pain. 7-10 readings represent severe pain .
1 secondary outcome
Intracanal bacterial load change.
Time frame: First as a base line and after 15 minutes ( End of the chemo-mechanical preparation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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 Rosmarinus Officinallis 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 6 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 22 Mar 2022. 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 Ayah Ta El Sayed, M.D.S (01221902479 ext. 002, ayahtarek94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain after root canal treatment. (time frame: Up to 48 hours postoperative.). 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 22 Mar 2022.