Postoperative PainPhase 4NCT03692286
Assessment of Postoperative Pain After Using Various Intracanal Medication in Patients With Necrotic Pulp
A Phase 4 study testing Silver nanoparticle/Calcium hydroxide, Silver Nanoparticles in gel form and Calcium Hydroxide Intracanal medication in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT) 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
- What is being tested?
- Silver nanoparticle/Calcium hydroxide, Silver Nanoparticles in gel form and Calcium Hydroxide Intracanal medication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 18 Sep 2020
- Phase
- Phase 4
- 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 who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Non-pregnant females
- Asymptomatic necrotic mandibular single rooted teeth.
- Normal occlusal contact with the opposing teeth.
- Patients accepting to participate in the study.
Who cannot join
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows:
- Association with acute periapical 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.
- Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
Show all 11Show fewer
- No restorability: Hopeless tooth.
- Vital teeth
- Immature teeth
- Radiographic evidence of external or internal root resorption.
- Any criterion, not mentioned in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Postoperative Pain After Using Silver Nanoparticles With and Without Calcium Hydroxide as an Intracanal Medication in Patients With Necrotic Pulp: (A Randomized Clinical Trial)
To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)
Read the detailed description
When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.
- Conditions
- Postoperative Pain
- Being tested
- Silver nanoparticle/Calcium hydroxide, Silver Nanoparticles in gel form, Calcium Hydroxide Intracanal medication
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver nanoparticle/Calcium hydroxideCombination product
Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide
Silver Nanoparticles in gel formDrug
Intracanal medication composed of silver nanoparticles in gel form
Calcium Hydroxide Intracanal medicationDrug
Calcium hydroxide intracanal medication
| Study group | Role | What they receive |
|---|---|---|
| AgNP/Ca(OH) | Active comparator | Patients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping Receives: Combination Product: Silver nanoparticle/Calcium hydroxide |
| AgNP | Active comparator | Patients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping Receives: Drug: Silver Nanoparticles in gel form |
| Ca(OH) | Active comparator | Patients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping Receives: Drug: Calcium Hydroxide Intracanal medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-operative pain
Numerical (0-10)
Measured: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours
Secondary outcomes (2)
Intracanal Bacterial count reduction
Quantification of Colony forming units per milliliter of agar medium (CFU/mL)
Measured: 1 week
Number of analgesic tablets taken by the patient after endodontic treatment
Number
Measured: Within 4 days after the first session and after 1 week from first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Jun 2019
- Primary completion18 Aug 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermine Elsayed Abdelsalam Hassan, Cairo University
- Investigators
- Nermine Hassan, Msc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692286
- Sponsor's protocol ID
- ENDO18
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data will be made available
Publications
Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
PubMed 23657409
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain After Using Silver Nanoparticles With and Without Calcium Hydroxide as an Intracanal Medication in Patients With Necrotic Pulp: (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03692286
- Acronym / sponsor ID
- ENDO18
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 2 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.
To assess the Postoperative Pain after using Silver Nanoparticles with and without Calcium Hydroxide as an Intracanal Medication in Patients with necrotic pulp (RCT)
Detailed description
When the treatment itself appears to initiate the onset of pain and/or swelling, the result can be very distressing to both the patient and the operator. Patients might even consider postoperative pain and flare-up as a benchmark against which the clinician's skills are measured. Prevalence of postoperative pain or flare-up is, therefore, one of the influencing factors when making a clinical decision. Better management of postoperative pain increases the patients' confidence in dentist's skills and gives positive attitude toward dental profession. In cases with necrotic pulp, the incidence of pain becomes higher, hence testing which intracanal medication is more effective in decreasing the bacteria present within the root canal and subsequently pain is crucial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AgNP/Ca(OH) | Active comparator | Combination Product: Silver nanoparticle/Calcium hydroxidePatients receiving combined Silver nanoparticle/Calcium hydroxide administered as intracanal medication at the first visit after cleaning and shaping |
| AgNP | Active comparator | Drug: Silver Nanoparticles in gel formPatients receiving silver nanoparticles in gel form administered as intracanal medication at the first visit after cleaning and shaping |
| Ca(OH) | Active comparator | Drug: Calcium Hydroxide Intracanal medicationPatients receiving calcium hydroxide intracanal medication at the first visit after cleaning and shaping |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Non-pregnant females
- Asymptomatic necrotic mandibular single rooted teeth.
- Normal occlusal contact with the opposing teeth.
- Patients accepting to participate in the study.
Key exclusion criteria (11 listed)
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively might alter their pain perception
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation Teeth that shows:
- Association with acute periapical 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.
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 |
|---|---|---|
| Silver nanoparticle/Calcium hydroxideIntracanal Medication composed of combined silver nanoparticles with calcium hydroxide | Combination product | AgNP/Ca(OH) |
| Silver Nanoparticles in gel formIntracanal medication composed of silver nanoparticles in gel form | Drug | AgNP |
| Calcium Hydroxide Intracanal medicationCalcium hydroxide intracanal medication | Drug | Ca(OH) |
Primary outcome
Change in post-operative pain
Time frame: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours
Numerical (0-10)
2 secondary outcomes
Intracanal Bacterial count reduction
Time frame: 1 week
Number of analgesic tablets taken by the patient after endodontic treatment
Time frame: Within 4 days after the first session and after 1 week from first treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 23657409Singh RD, Khatter R, Bal RK, Bal CS. Intracanal medications versus placebo in reducing postoperative endodontic pain--a double-blind randomized clinical trial. Braz Dent J. 2013;24(1):25-9. doi: 10.1590/0103-6440201302039.
- Individual participant dataSharing planned: Yes. Participant data will be made available
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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.
Nermine Hassan, Msc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silver nanoparticle/Calcium hydroxide, Silver Nanoparticles in gel form and Calcium Hydroxide Intracanal medication in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
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 11 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: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 post-operative pain (time frame: Intra-appointment and post obturation at 4, 24, 48, 72, 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692286, which also lists 1 linked publication.
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 Oct 2020.