InterventionNCT06509295
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. .
A study testing Calcium Hypochlorite as Root Canal Irrigant in people with Intervention, run by Cairo University.
Trial summary
This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Intervention
- What is being tested?
- Calcium Hypochlorite as Root Canal Irrigant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2024to 29 May 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systematically healthy patient (ASA I, II).
- Age between 20 and 55 years
- Male or female.
- Mandibular premolar teeth having single canals diagnosed with pulp necrosis with asymptomatic apical periodontitis.
- Radiographic examination using Digora intraoral periapical sensor plate and software showing mandibular premolars with (0-2 mm) periapical radiolucency.
Who cannot join
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Teeth with:
- Immature roots
- Vital pulp tissues.
- Association with swelling.
Show all 13Show fewer
- 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 who could not interpret the NRS.
- Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. A Randomized Clinical Trial.
This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.
- Conditions
- Intervention
- Being tested
- Calcium Hypochlorite as Root Canal Irrigant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hypochlorite as Root Canal IrrigantOther
Calcium Hypochlorite used as root canal irrigant during chemo-mechanical preparation
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction | Placebo comparator | Treatment with Calcium Hypochlorite as root canal Irrigant Receives: Other: Calcium Hypochlorite as Root Canal Irrigant |
| Sodium Hypochlorite as a root Canal Irrigant | Active comparator | Treatment with Sodium Hypochlorite as root canal Irrigant Receives: Other: Calcium Hypochlorite as Root Canal Irrigant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps.
measuring tool: Numerical Rating Scale (NRS). Unite of measurement: Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10 Time of measurements: At 6, 12, 24, 48- hours post-treatment.
Measured: measured at 6, 12, 24, 48 hours after single visit treatment
Secondary outcomes (2)
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.
Intracanal bacterial load reduction will be determined by bacterial counting using agar culture technique after root canal preparation (CFUs/ml), The growth will be semi quantitatively determined as very heavy, heavy, moderate, sparse and very sparse depending on the CFU ranging from >100,000,˂100,000,˂10,000,˂1,000, ˂100 colony forming unit per 1 ml BHI respectively.
Measured: T0=Baseline immediate after access preparation . T1=Post-instrumentation. T1(within an hour)
Number of analgesic tablets taken by the patient after endodontic treatment
Number of analgesic tablets taken by the patient after endodontic treatment Up to 48 hours postoperative.
Measuring tool: counting Measurment unite: numerical.
Measured: Up to 48 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start29 Aug 2024 (estimated)
- Primary completion20 Apr 2025 (estimated)
- Study completion29 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youmna Yassen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509295
- Sponsor's protocol ID
- ENDO 3-7-1(10/4/2024)
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06509295
- Acronym / sponsor ID
- ENDO 3-7-1(10/4/2024)
- Conditions
- Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Aug 2024 (estimated)
- Primary completion
- 20 Apr 2025 (estimated)
- Study completion
- 29 May 2025 (estimated)
- First posted
- 19 Jul 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.
This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction | Placebo comparator | Other: Calcium Hypochlorite as Root Canal IrrigantTreatment with Calcium Hypochlorite as root canal Irrigant |
| Sodium Hypochlorite as a root Canal Irrigant | Active comparator | Other: Calcium Hypochlorite as Root Canal IrrigantTreatment with Sodium Hypochlorite as root canal Irrigant |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systematically healthy patient (ASA I, II).
- Age between 20 and 55 years
- Male or female.
- Mandibular premolar teeth having single canals diagnosed with pulp necrosis with asymptomatic apical periodontitis.
- Radiographic examination using Digora intraoral periapical sensor plate and software showing mandibular premolars with (0-2 mm) periapical radiolucency.
Key exclusion criteria (13 listed)
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Teeth with:
- Patients who could not interpret the NRS.
- Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
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 |
|---|---|---|
| Calcium Hypochlorite as Root Canal IrrigantCalcium Hypochlorite used as root canal irrigant during chemo-mechanical preparation | Other | Calcium Hypochlorite as root canal Irrigant on Postoperative Pain and bacterial load reduction, Sodium Hypochlorite as a root Canal Irrigant |
Primary outcome
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps.
Time frame: measured at 6, 12, 24, 48 hours after single visit treatment
measuring tool: Numerical Rating Scale (NRS). Unite of measurement: Categorical None 0 Mild 1-3 Moderate 4-6 Severe 7-10 Time of measurements: At 6, 12, 24, 48- hours post-treatment.
2 secondary outcomes
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.
Time frame: T0=Baseline immediate after access preparation . T1=Post-instrumentation. T1(within an hour)
Number of analgesic tablets taken by the patient after endodontic treatment
Time frame: Up to 48 hours postoperative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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 Calcium Hypochlorite as Root Canal Irrigant in people with Intervention, 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 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 19 Jul 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.
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 Youmna Yassen Youmna Yassen, pds (01146877037, youmna_yassen@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain in Mandibular Premolars with Necrotic Pulps. (time frame: 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 19 Jul 2024.