Post Operative PainNCT04622488
The Effect of Diclofenac Potassium Insitu Gel Vs Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect
A study testing Diclofenac Potassium in people with Post Operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Diclofenac Potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2020to Sep 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-45 years old.
- Males/Females.
- Lower permanent premolars with: Non-Vital pulps. Sensitive to percussion. Negative response to cold pulp tester (ethyl chloride spray1). Apical periodontitis
- Systemically healthy patients (ASA I or II).
Who cannot join
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- Teeth with :
- Association with swelling or fistulous tract.
- Acute or chronic peri-apical abscess. Mobility Grade II or III.
Show all 10Show fewer
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability
- Patients with a contraindication for the use of DFK or those known to be allergic to any of the study medications.eg. Patient with kidney problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Cairo University
Cairo, El- Manial, 11553
Heba El Far, Professor, +201282006589, hebaelfar@hotmail.com
Dina Morsy, Doctorate, +201223980157, dina.amorsy@dentistry.cu.edu.eg
About this study
Official title: The Effect of Diclofenac Potassium Insitu Gel Versus Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect in Lower Non Vital Premolars With Symptomatic Apical Periodontitis
The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis.
- Conditions
- Post Operative Pain
- Being tested
- Diclofenac Potassium
- Keywords
- Calcium Hydroxide, Diclofenac potassium, Intra-canal Medications
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac PotassiumDrug
Also called Cataflam
- In the form of Insitu gel system can be applied as solution or suspension that undergoes gelation after administration. Applied once inside the root canal after chemo-mechanical preparation.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Potassium | Active comparator | In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration. Receives: Drug: Diclofenac Potassium |
| Calcium Hydroxide | Experimental | Not described Receives: Drug: Diclofenac Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post operative pain assessed by VAS
Post-operative pain following chemo-mechanical endodontic treatment will be measured.
A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow:
- 0, "no pain"
- 1-3, "mild pain"
- 4-6, "moderate pain"
- 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
Measured: 72 hours
Secondary outcomes (1)
Antibacterial effectiveness by measuring the bacterial count.
The bacterial count method will be used. Once the samples will arrive to the microbiology department, Cairo University, the tubes containing the thioglycolate 14(transport medium) with the paper points will be placed in micro centrifuge and vortexed for 30 sec. One hundred (100) μl aliquots of the vortexed samples will be placed in a new sterile tube containing 1 ml of thioglycolate to obtain 1/10 concentration to assess the microbial load of common aerobes and anaerobes found in each root canal. The effect of the treatment in each group, the initial colonizers (S1), the mechanical preparation (S2) and after the intra-canal medication (S3) will be compared.
Measured: pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohamed Aboul Azayem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622488
- Sponsor's protocol ID
- ENDO 3-7-2
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diclofenac Potassium Insitu Gel Versus Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect in Lower Non Vital Premolars With Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT04622488
- Acronym / sponsor ID
- ENDO 3-7-2
- Conditions
- Post Operative Pain
- Keywords
- Calcium Hydroxide, Diclofenac potassium, Intra-canal Medications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 10 Nov 2020 (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.
The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Potassium | Active comparator | Drug: Diclofenac PotassiumIn the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration. |
| Calcium Hydroxide | Experimental | Drug: Diclofenac Potassium |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-45 years old.
- Males/Females.
- Lower permanent premolars with: Non-Vital pulps. Sensitive to percussion. Negative response to cold pulp tester (ethyl chloride spray1). Apical periodontitis
- Systemically healthy patients (ASA I or II).
Key exclusion criteria (10 listed)
- Medically compromised patients having significant systemic disorders. (ASA III or IV).
- Association with swelling or fistulous tract.
- Acute or chronic peri-apical abscess. Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
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 |
|---|---|---|
| Diclofenac PotassiumAlso: Cataflam- In the form of Insitu gel system can be applied as solution or suspension that undergoes gelation after administration. Applied once inside the root canal after chemo-mechanical preparation. | Drug | Calcium Hydroxide, Diclofenac Potassium |
Primary outcome
Incidence of Post operative pain assessed by VAS
Time frame: 72 hours
Post-operative pain following chemo-mechanical endodontic treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: * 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
1 secondary outcome
Antibacterial effectiveness by measuring the bacterial count.
Time frame: pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac Potassium in people with Post Operative 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 4 inclusion and 10 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 10 Nov 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.
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 Heba El Far, Professor (+201282006589, hebaelfar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post operative pain assessed by VAS (time frame: 72 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 10 Nov 2020.