Postoperative PainNCT03724266
Effect of Using Nanochitosan Versus Calcium Hydroxide as Disinfectant on Pain and Apical Bone Healing
A study testing Chitosan and Calcium Hydroxide in people with Postoperative Pain and Healing, run by Cairo University.
Trial summary
Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Healing
- What is being tested?
- Chitosan and Calcium Hydroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Dec 2020
- 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
- Patients in good general health.
- Patient's age ranging between 20-40 years with no sex predilection.
- Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.
- Evidence of apical radiolucency (minimum size 2 mm x 2 mm).
- Patients' acceptance to participate in the study.
Who cannot join
- Medically compromised patients with a severe systemic condition.
- Pregnant female patients.
- Patients who had taken any antibiotic or analgesics during the past 24 hours.
- Presence of a swelling because emergency management may include incision and drainage.
- Retreatment cases.
- Generalized periodontitis (calculus, deep pockets).
- Out of normal variations (open apex- severely curved canal- obstructed canal).
About this study
Official title: Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
Read the detailed description
PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).
I (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.
O (outcome):
Primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours
Secondary outcome:
- Postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months
- Number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week.
- healing of apical periodontitis using CBCT at 3, 6, 12 months
- Conditions
- Postoperative Pain, Healing
- Being tested
- Chitosan, Calcium Hydroxide
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChitosanDrug
chitosan will be used as intracanal medication
Calcium HydroxideDrug
Also called CaOH
intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| chitosan | Experimental | chitosan as intracanal medication 0.2% in form of gel Receives: Drug: Chitosan |
| calcium hydroxide | Active comparator | intracanal medication Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postoperative pain after intervention of chitosan: NRS
pain assessed by numerical rating scale, pain will be assessed using a numerical rating scale (NRS) which is proven to be a simple, valid, and a reliable pain measurement tool. The NRS consists of a series of numbers from zero to 10 with the end-points representing the extremes of pain as "no pain" and "the worst possible pain". Patients will rank their pain level by making a mark on the number they thought it represented their pain. The pain intensity is assigned into four categorical scores: 1, no pain (score 0); 2, mild (scores 1-3); 3, moderate (scores 4-6); 4, severe (scores 7-10). Pain is evaluated preoperatively and postoperatively after the initial visit at 4, 12, 24, 48, 72 hours
Measured: 4,12,24,27 hours
Secondary outcomes (1)
change in healing of apical periodontitis
linear measurment of apical radiolucency using cone beam computed tomography
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- postoperative pain after intervention
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed abdelmonam abd elmougoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724266
- Sponsor's protocol ID
- ahmed abdelmonam
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 1 Nov 2018
- 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 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Nanochitosan Versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
- ClinicalTrials.gov ID
- NCT03724266
- Acronym / sponsor ID
- ahmed abdelmonam
- Conditions
- Postoperative Pain, Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 Oct 2018 (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.
Effect of Using Nanochitosan versus Calcium Hydroxide as Intracanal Medications on the Postoperative Pain and Apical Bone Healing
Detailed description
PICO approach P (population): maxillary anterior teeth having necrotic pulp with symptomatic apical periodontitis with evidence of apical radiolucency (minimum size 2 mm x 2 mm).
I (intervention):0.2% nanochitosan as intracanal medication. C (control): calcium hydroxide paste intracanal medication.
O (outcome):
Primary outcome: postoperative pain at time interval 4, 12, 24, 48, 72 hours
Secondary outcome:
- Postoperative pain, swelling, palpation, percussion and mobility at one week, 3, 6, 12 months
- Number of analgesic tablets used at 4, 12, 24, 48, 72 hours and one week.
- healing of apical periodontitis using CBCT at 3, 6, 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- postoperative pain after intervention
| Arm | Type | Receives |
|---|---|---|
| chitosan | Experimental | Drug: Chitosanchitosan as intracanal medication 0.2% in form of gel |
| calcium hydroxide | Active comparator | Drug: Calcium Hydroxideintracanal medication |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in good general health.
- Patient's age ranging between 20-40 years with no sex predilection.
- Maxillary anterior teeth with non-vital pulp and symptomatic apical periodontitis.
- Evidence of apical radiolucency (minimum size 2 mm x 2 mm).
- Patients' acceptance to participate in the study.
Key exclusion criteria (7 listed)
- Medically compromised patients with a severe systemic condition.
- Pregnant female patients.
- Patients who had taken any antibiotic or analgesics during the past 24 hours.
- Presence of a swelling because emergency management may include incision and drainage.
- Retreatment cases.
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 |
|---|---|---|
| Chitosanchitosan will be used as intracanal medication | Drug | chitosan |
| Calcium HydroxideAlso: CaOHintracanal medication | Drug | calcium hydroxide |
Primary outcome
change in postoperative pain after intervention of chitosan: NRS
Time frame: 4,12,24,27 hours
pain assessed by numerical rating scale, pain will be assessed using a numerical rating scale (NRS) which is proven to be a simple, valid, and a reliable pain measurement tool. The NRS consists of a series of numbers from zero to 10 with the end-points representing the extremes of pain as "no pain" and "the worst possible pain". Patients will rank their pain level by making a mark on the number they thought it represented their pain. The pain intensity is assigned into four categorical scores: 1, no pain (score 0); 2, mild (scores 1-3); 3, moderate (scores 4-6); 4, severe (scores 7-10). Pain is evaluated preoperatively and postoperatively after the initial visit at 4, 12, 24, 48, 72 hours
1 secondary outcome
change in healing of apical periodontitis
Time frame: 3,6,12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chitosan and Calcium Hydroxide in people with Postoperative Pain and Healing, 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 7 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 1 Nov 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in postoperative pain after intervention of chitosan: NRS (time frame: 4,12,24,27 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 1 Nov 2018.