InterventionNCT06253247
Effect of NanoChitosan Impregnated Calcium Hydroxide as an Intracanal Medication on Postoperative Pain Intensity and Bacterial Load Reduction
A study testing NanoChitosan impregnated Calcium Hydroxide in people with Intervention, run by Cairo University.
Trial summary
This research will study the effect of NanoChitosan impregnated Calcium Hydroxide versus Calcium Hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention
- What is being tested?
- NanoChitosan impregnated Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Jun 2024
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 25-45 years old.
- Males or females.
- Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
- Patients' accepting to participate in the trial.
- Patients who can understand the pain scale and can sign the informed consent.
- Mandibular Single rooted premolars, having single root canal: Diagnosed clinically with pulp necrosis.
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- Positive pain on percussion denoting apical periodontitis.(20)
- Slight widening in the periodontal membrane space
- Normal occlusal contact with opposing teeth
Who cannot join
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- Pregnant women
- Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Teeth that require further procedural steps or multidisciplinary approach.
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- Association with swelling or fistulous tract.
- Acute periapical abscess.
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal treatment.
- Non-restorable.
- Immature root.
- Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
- Inability to perceive the given instructions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of NanoChitosan Impregnated Calcium Hydroxide Paste as an Intracanal Medication on the Intensity of Postoperative Pain and Bacterial Load Reduction in Necrotic Teeth: A Randomized Controlled Trial
This research will study the effect of NanoChitosan impregnated Calcium Hydroxide versus Calcium Hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in necrotic teeth.
Read the detailed description
Primary outcome: Postoperative pain measured using numerical rating scale (NRS)
- After placement of intracanal medicament at 6, 12, 24 and 48 hours.
- After root canal obturation at 6, 12, 24 and 48 hours.
Secondary outcome: Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml)
- Sample 1 (S1): after access preparation and pre-instrumentation.
- Sample 2 (S2): post-instrumentation.
- Sample 3 (S3): post-intracanal medicament removal at 7 days.
- Conditions
- Intervention
- Being tested
- NanoChitosan impregnated Calcium Hydroxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoChitosan impregnated Calcium HydroxideCombination product
NanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days
| Study group | Role | What they receive |
|---|---|---|
| Patients with necrotic mandibular premolars will be treated with NanoChitosan impregnated Ca(OH)2 | Experimental | 25-45 years old patients with necrotic single rooted mandibular premolars with single canal will be treated with NanoChitosan impregnated Calcium Hydroxide as an intracanal medicament for 7 days Receives: Combination Product: NanoChitosan impregnated Calcium Hydroxide |
| Patients with necrotic mandibular premolars will be treated with Calcium Hydroxide | Active comparator | 25-45 years old patients with necrotic single rooted mandibular premolars with single canal will be treated with calcium hydroxide as an intracanal medicament for 7 days Receives: Combination Product: NanoChitosan impregnated Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured using numerical rating scale
postoperative pain will be recorded after placement of intracanal medicament and after root canal obturation using numerical rating scale ,An 11-point scale from 0-10 representing pain intensity ,"10" being the most intense pain conceivable.
Measured: 48 hours
Secondary outcomes (3)
Bacterial load reduction
Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (Number of colony forming unit per millilitre)
Measured: T0=Baseline immediate after access preparation . T1=Post-instrumentation. T2=post-intracanal medicament removal at 7 days.
Incidence of inter- appointment flare up
recording the incidence of inter-appointment flare up with a binary scale
Measured: Up to 48 hours post- operatively
Number of analgesic tablets taken by the patient after endodontic treatment
Number of analgesic tablets intake after root canal treatment, using numerical counting.
Measured: Up to 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 posted12 Feb 2024
- Study startApr 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (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
- Model description
- Parallel randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Osama ElGhannam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253247
- Sponsor's protocol ID
- ICM 101
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NanoChitosan Impregnated Calcium Hydroxide Paste as an Intracanal Medication on the Intensity of Postoperative Pain and Bacterial Load Reduction in Necrotic Teeth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06253247
- Acronym / sponsor ID
- ICM 101
- Conditions
- Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 12 Feb 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 research will study the effect of NanoChitosan impregnated Calcium Hydroxide versus Calcium Hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in necrotic teeth.
Detailed description
Primary outcome: Postoperative pain measured using numerical rating scale (NRS)
- After placement of intracanal medicament at 6, 12, 24 and 48 hours.
- After root canal obturation at 6, 12, 24 and 48 hours.
Secondary outcome: Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml)
- Sample 1 (S1): after access preparation and pre-instrumentation.
- Sample 2 (S2): post-instrumentation.
- Sample 3 (S3): post-intracanal medicament removal at 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Patients with necrotic mandibular premolars will be treated with NanoChitosan impregnated Ca(OH)2 | Experimental | Combination Product: NanoChitosan impregnated Calcium Hydroxide25-45 years old patients with necrotic single rooted mandibular premolars with single canal will be treated with NanoChitosan impregnated Calcium Hydroxide as an intracanal medicament for 7 days |
| Patients with necrotic mandibular premolars will be treated with Calcium Hydroxide | Active comparator | Combination Product: NanoChitosan impregnated Calcium Hydroxide25-45 years old patients with necrotic single rooted mandibular premolars with single canal will be treated with calcium hydroxide as an intracanal medicament for 7 days |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age between 25-45 years old.
- Males or females.
- Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
- Patients' accepting to participate in the trial.
- Patients who can understand the pain scale and can sign the informed consent.
Key exclusion criteria (15 listed)
- Medically compromised patients having significant systemic disorders (ASA III or IV).
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- Pregnant women
- Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion
- Patients with two or more adjacent teeth requiring endodontic treatment.
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 |
|---|---|---|
| NanoChitosan impregnated Calcium HydroxideNanoChitosan impregnated Calcium Hydroxide used as an intracanal medication fro 7 days | Combination product | Patients with necrotic mandibular premolars will be treated with Calcium Hydroxide, Patients with necrotic mandibular premolars will be treated with NanoChitosan impregnated Ca(OH)2 |
Primary outcome
Postoperative pain measured using numerical rating scale
Time frame: 48 hours
postoperative pain will be recorded after placement of intracanal medicament and after root canal obturation using numerical rating scale ,An 11-point scale from 0-10 representing pain intensity ,"10" being the most intense pain conceivable.
3 secondary outcomes
Bacterial load reduction
Time frame: T0=Baseline immediate after access preparation . T1=Post-instrumentation. T2=post-intracanal medicament removal at 7 days.
Incidence of inter- appointment flare up
Time frame: Up to 48 hours post- operatively
Number of analgesic tablets taken by the patient after endodontic treatment
Time frame: Up to 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 12 Feb 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 NanoChitosan impregnated Calcium Hydroxide 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 9 inclusion and 15 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 12 Feb 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 Yasmine ElGhannam (+201099978023, y.elghannam@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain measured using numerical rating scale (time frame: 48 hours). 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 12 Feb 2024.