Acute PulpitisNCT04012424
The Effect of Premedication With Curcumin on Post-endodontic Pain
A study testing curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf and 400mg starch in people with Acute Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
Will premedication with Curcumin in single endodontic treatment in patients having acute pulpitis in mandibular molars affect post- operative pain? This the present study hopes to bring an evidence based decision on the possibility of using curcumin as a premedication to reduce post-operative pain in single visit… Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pulpitis
- What is being tested?
- curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf and 400mg starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 1 Nov 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 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female
- Patients with age range 20- 55y
- Mandibular molars with acute pulpitis.
- Teeth with mature root
Who cannot join
- Pregnant or lactating females
- Teeth with non vital pulp
- Non- restorable teeth
- Medically compromised patients(diabetics-bleeding disorder- hypertensive )
- Patients with facial swelling or acute infection.
- Previously endodontically treated teeth
Show all 9Show fewer
- Periodontally affected teeth.
- Teeth with calcified root canals, root caries, internal or external root resorption, sign of crack formation and anatomic abnormalities.
- Patients taking analgesic medication before 12hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Premedication With Curcumin on Post-Operative Pain in Single Visit Endodontic Treatment of Acute Pulpitis in Mandibular Molars: A Randomized Controlled Trial
Will premedication with Curcumin in single endodontic treatment in patients having acute pulpitis in mandibular molars affect post- operative pain?
This the present study hopes to bring an evidence based decision on the possibility of using curcumin as a premedication to reduce post-operative pain in single visit treatment of cases with acute pulpitis
Read the detailed description
The diagnostic data will be collected in a general health chart and dental history sheet by the investigator and confirmed for eligibility criteria with main supervisor.
Clinical examination through visual, palpation and percussion of offending tooth is done. Pulp sensitivity test will be done for baseline comparison. It will be performed by both by electric and thermal tests on offending tooth and the contralateral. Preoperative periapical radiograph is done to evaluate pulp chamber size and shape, root and root canals and detect any per apical changes.
The selected mandibular molars should have final diagnosis of acute pulpitis.
Diagnostic criteria for acute pulpitis tooth:
Palpation test: not sensitive \& Percussion test: not sensitive \&Thermal test: hypersensitive to heat or cold \& Radiographic: periapical radiograph shows normal periapex • Sequence of procedural steps:
The study protocol is described to the patients and they sign an informed consent . Each patient will be given pain scale chart (VAS) in order to record his /her pain level before any intervention, and then patients will be given the premedication according to the study group:
Group A" intervention or Curcumin group ": (400mg Curcumin) in one capsule Group B" placebo group ": starch capsule, Both capsules of intervention and placebo groups will have the same shape, color and are prepared by Professor Doctor Mohamed Elnabarawy in the faculty of pharmacology, Cairo University. Every patient takes one capsule before endodontic treatment by one hour according to randomization sequence table prepared by the main supervisor utilizing "random.org".
The researcher will give nerve block anesthesia according to the region of the tooth will be treated, ARTINIBSA 4% articaine hydrochloride 4% with 1:100,000 epinephrine as vasoconstrictor will be used.
An access cavity is performed by using round bur and endo-z bur, afterwards. The tooth will be properly isolated with rubber dam. Irrigation is done with 2ml 2.5% Sodium hypochlorite (Clorox, Nobelwax Factories for chemicals, Egypt) , then canal negotiation with K-file #15 (K-file, Dentsply Maillefer , Switzerland), and working length will be determined using an electronic apex locator (iPex NSK,Japan) and confirmed radiographically, sequentionaly larger file sizes will be introduced to the working length to gague the initional apical file size.
Mechanical preparation will be performed by crown-down technique using rotary M-Pro files, in an endodontic motor (Endo mate, NSK, Japan) with adjusted torque and speed according to the manufacturer's instructions ( 450 rpm -1.5 Ncm). Gauging apical diameter will be done with manual files to determine the master apical file size. If necessary; further larger apical preparation will be done with by manual files. The rotary files will be introduced inside the canal lubricated with EDTA Cream (MD-Chelcream, META BIOMED CO, Korea) The canals are thoroughly irrigated using 2.5% NaOCl between every subsequent instrument by using side vented needle, 27 gauge, with maximum depth of working length - 1mm. The irrigant is delivered having 2ml volume at a rate 1ml/30 second.
Root canal is dried using sterile paper points corresponding to master cone size followed by doing master cone periapical radiograph by ViVi, S.r.I, Italy- X-ray machine and intraoral periapical Kodak Dental film, speed D, #2.
Obturation of the canals is done by lateral compaction technique and master cone cementated by resin sealer (ADSEAL, META BIOMED CO., Korea). A spreader #30 will be used 2mm short of working length to allow for auxiliary cones #25, taper 2% to be added and excess will be removed with hot instrument up to cervical line followed by insertion of temporary filling to seal the access cavity.
Post-operative periapical radiograph is taken after obturation. Pain will be assessed by giving the patient the pain scale (VAS) to assess pain immediately after treatment and at 8, 12,24,48 hours after the visit.
VAS pain scale is horizontal scale from1-100mm.patient mark on the scale and investigator will measure with ruler and conert to cateigories as follow (0-40mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) .
Patients will come back at clinic after 48hours and deliver their signed scoring sheet and referred to restorative department for permanent restoration.
- In case of post appointment emergency cases:
The pain is recorded by pain scale and emergency treatment done according to pain severity; recording of pain scale is continued according to schedule time line. Sequence of emergency treatment includes:
- Make sure the tooth is out of occlusion
- Hot saline mouth bath
- When pain is moderate /severe: Anti- inflammatory: ibuprofen600 tab/8hr (6)
- Antibiotics (is only prescribed in presence of swelling and/or systemic manifestations as malaise or palpable lymph nodes or fever) Hibiotic 1gm tab/12hrs and Flagel 500 mg tab/12 hrs for 5 days N.B if allergic to penicillin; Dalacin C 300 mg cap/8hrs for 5days
- Conditions
- Acute Pulpitis
- Being tested
- curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf, 400mg starch
- Keywords
- curcumin as premedication - root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-infDrug
Also called curcum-tumeric
effect of taking 400mg curcumin one hour before endodontic ttt on post endodontic pain immediatelly and after 8,12,24,48 hours after endodontic treatment.Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect .
Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis .
other name : curcum, tumeric
400mg starchDietary supplement
patints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion
| Study group | Role | What they receive |
|---|---|---|
| Drug (400mg Curcumin) Curcumin is apice | Experimental | Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect .
Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis .
patients will take 400mg capsule curcumin one hour before endodontic treatment and study its effect on post endodontic pain immediately and after 8,12,24,48 hours after completion of endodontic treatment Receives: Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf; Dietary Supplement: 400mg starch |
| Starch(400mg starch) starch is sometype of carbohydrates | Placebo comparator | patints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion Receives: Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf; Dietary Supplement: 400mg starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in post operative pain after single endodontic visit
intenisty of postoperative pain by using VAS pain scale which is horizontal scale from0-100mm which patient will on degree of his/her pain level and investigator will measure it with ruler and convert to catogries as follow (0-4mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) : severe.
Measured: immediately and after 8,12,24,48 hours after completion endodontic treatment
Secondary outcomes (1)
number of analgesic tablets taken
counting of analgesic tablets taken from rescue medication (ibuprofen600 tab)
Measured: immediately and after 8,12,24,48 hours after completion endodontic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PulpitisStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Sobhy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012424
- Sponsor's protocol ID
- ENDO 3-7-1
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2019
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taylor H, Warfield CA. Thermography of pain: instrumentation and uses. Hosp Pract (Off Ed). 1985 Nov 15;20(11):164, 168-9. doi: 10.1080/21548331.1985.11703194. No abstract available.
PubMed 2997245Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.
PubMed 28320541Arslan H, Topcuoglu HS, Aladag H. Effectiveness of tenoxicam and ibuprofen for pain prevention following endodontic therapy in comparison to placebo: a randomized double-blind clinical trial. J Oral Sci. 2011 Jun;53(2):157-61. doi: 10.2334/josnusd.53.157.
PubMed 21712619Mokhtari F, Yazdi K, Mahabadi AM, Modaresi SJ, Hamzeheil Z. Effect of Premedication with Indomethacin and Ibuprofen on Postoperative Endodontic Pain: A Clinical Trial. Iran Endod J. 2016 Winter;11(1):57-62. doi: 10.7508/iej.2016.01.011. Epub 2015 Dec 24.
PubMed 26843879
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Premedication With Curcumin on Post-Operative Pain in Single Visit Endodontic Treatment of Acute Pulpitis in Mandibular Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04012424
- Acronym / sponsor ID
- ENDO 3-7-1
- Conditions
- Acute Pulpitis
- Keywords
- curcumin as premedication - root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 9 Jul 2019 (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.
Will premedication with Curcumin in single endodontic treatment in patients having acute pulpitis in mandibular molars affect post- operative pain?
This the present study hopes to bring an evidence based decision on the possibility of using curcumin as a premedication to reduce post-operative pain in single visit treatment of cases with acute pulpitis
Detailed description
The diagnostic data will be collected in a general health chart and dental history sheet by the investigator and confirmed for eligibility criteria with main supervisor.
Clinical examination through visual, palpation and percussion of offending tooth is done. Pulp sensitivity test will be done for baseline comparison. It will be performed by both by electric and thermal tests on offending tooth and the contralateral. Preoperative periapical radiograph is done to evaluate pulp chamber size and shape, root and root canals and detect any per apical changes.
The selected mandibular molars should have final diagnosis of acute pulpitis.
Diagnostic criteria for acute pulpitis tooth:
Palpation test: not sensitive \& Percussion test: not sensitive \&Thermal test: hypersensitive to heat or cold \& Radiographic: periapical radiograph shows normal periapex • Sequence of procedural steps:
The study protocol is described to the patients and they sign an informed consent . Each patient will be given pain scale chart (VAS) in order to record his /her pain level before any intervention, and then patients will be given the premedication according to the study group:
Group A" intervention or Curcumin group ": (400mg Curcumin) in one capsule Group B" placebo group ": starch capsule, Both capsules of intervention and placebo groups will have the same shape, color and are prepared by Professor Doctor Mohamed Elnabarawy in the faculty of pharmacology, Cairo University. Every patient takes one capsule before endodontic treatment by one hour according to randomization sequence table prepared by the main supervisor utilizing "random.org".
The researcher will give nerve block anesthesia according to the region of the tooth will be treated, ARTINIBSA 4% articaine hydrochloride 4% with 1:100,000 epinephrine as vasoconstrictor will be used.
An access cavity is performed by using round bur and endo-z bur, afterwards. The tooth will be properly isolated with rubber dam. Irrigation is done with 2ml 2.5% Sodium hypochlorite (Clorox, Nobelwax Factories for chemicals, Egypt) , then canal negotiation with K-file #15 (K-file, Dentsply Maillefer , Switzerland), and working length will be determined using an electronic apex locator (iPex NSK,Japan) and confirmed radiographically, sequentionaly larger file sizes will be introduced to the working length to gague the initional apical file size.
Mechanical preparation will be performed by crown-down technique using rotary M-Pro files, in an endodontic motor (Endo mate, NSK, Japan) with adjusted torque and speed according to the manufacturer's instructions ( 450 rpm -1.5 Ncm). Gauging apical diameter will be done with manual files to determine the master apical file size. If necessary; further larger apical preparation will be done with by manual files. The rotary files will be introduced inside the canal lubricated with EDTA Cream (MD-Chelcream, META BIOMED CO, Korea) The canals are thoroughly irrigated using 2.5% NaOCl between every subsequent instrument by using side vented needle, 27 gauge, with maximum depth of working length - 1mm. The irrigant is delivered having 2ml volume at a rate 1ml/30 second.
Root canal is dried using sterile paper points corresponding to master cone size followed by doing master cone periapical radiograph by ViVi, S.r.I, Italy- X-ray machine and intraoral periapical Kodak Dental film, speed D, #2.
Obturation of the canals is done by lateral compaction technique and master cone cementated by resin sealer (ADSEAL, META BIOMED CO., Korea). A spreader #30 will be used 2mm short of working length to allow for auxiliary cones #25, taper 2% to be added and excess will be removed with hot instrument up to cervical line followed by insertion of temporary filling to seal the access cavity.
Post-operative periapical radiograph is taken after obturation. Pain will be assessed by giving the patient the pain scale (VAS) to assess pain immediately after treatment and at 8, 12,24,48 hours after the visit.
VAS pain scale is horizontal scale from1-100mm.patient mark on the scale and investigator will measure with ruler and conert to cateigories as follow (0-40mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) .
Patients will come back at clinic after 48hours and deliver their signed scoring sheet and referred to restorative department for permanent restoration.
- In case of post appointment emergency cases:
The pain is recorded by pain scale and emergency treatment done according to pain severity; recording of pain scale is continued according to schedule time line. Sequence of emergency treatment includes:
- Make sure the tooth is out of occlusion
- Hot saline mouth bath
- When pain is moderate /severe: Anti- inflammatory: ibuprofen600 tab/8hr (6)
- Antibiotics (is only prescribed in presence of swelling and/or systemic manifestations as malaise or palpable lymph nodes or fever) Hibiotic 1gm tab/12hrs and Flagel 500 mg tab/12 hrs for 5 days N.B if allergic to penicillin; Dalacin C 300 mg cap/8hrs for 5days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug (400mg Curcumin) Curcumin is apice | Experimental | Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf, Dietary Supplement: 400mg starchCurcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect . Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis . patients will take 400mg capsule curcumin one hour before endodontic treatment and study its effect on post endodontic pain immediately and after 8,12,24,48 hours after completion of endodontic treatment |
| Starch(400mg starch) starch is sometype of carbohydrates | Placebo comparator | Drug: curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf, Dietary Supplement: 400mg starchpatints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female
- Patients with age range 20- 55y
- Mandibular molars with acute pulpitis.
- Teeth with mature root
Key exclusion criteria (9 listed)
- Pregnant or lactating females
- Teeth with non vital pulp
- Non- restorable teeth
- Medically compromised patients(diabetics-bleeding disorder- hypertensive )
- Patients with facial swelling or acute infection.
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 |
|---|---|---|
| curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-infAlso: curcum-tumericeffect of taking 400mg curcumin one hour before endodontic ttt on post endodontic pain immediatelly and after 8,12,24,48 hours after endodontic treatment.Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect . Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis . other name : curcum, tumeric | Drug | Drug (400mg Curcumin) Curcumin is apice, Starch(400mg starch) starch is sometype of carbohydrates |
| 400mg starchpatints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion | Dietary supplement | Drug (400mg Curcumin) Curcumin is apice, Starch(400mg starch) starch is sometype of carbohydrates |
Primary outcome
change in post operative pain after single endodontic visit
Time frame: immediately and after 8,12,24,48 hours after completion endodontic treatment
intenisty of postoperative pain by using VAS pain scale which is horizontal scale from0-100mm which patient will on degree of his/her pain level and investigator will measure it with ruler and convert to catogries as follow (0-4mm): no pain, (5-44mm) : mild, (45-74mm): moderate,(75-100) : severe.
1 secondary outcome
number of analgesic tablets taken
Time frame: immediately and after 8,12,24,48 hours after completion endodontic treatment
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 13 Aug 2021.
- Background: PubMed 2997245Taylor H, Warfield CA. Thermography of pain: instrumentation and uses. Hosp Pract (Off Ed). 1985 Nov 15;20(11):164, 168-9. doi: 10.1080/21548331.1985.11703194. No abstract available.
- Background: PubMed 28320541Praveen R, Thakur S, Kirthiga M. Comparative Evaluation of Premedication with Ketorolac and Prednisolone on Postendodontic Pain: A Double-blind Randomized Controlled Trial. J Endod. 2017 May;43(5):667-673. doi: 10.1016/j.joen.2016.12.012. Epub 2017 Mar 17.
- Background: PubMed 21712619Arslan H, Topcuoglu HS, Aladag H. Effectiveness of tenoxicam and ibuprofen for pain prevention following endodontic therapy in comparison to placebo: a randomized double-blind clinical trial. J Oral Sci. 2011 Jun;53(2):157-61. doi: 10.2334/josnusd.53.157.
- Background: PubMed 26843879Mokhtari F, Yazdi K, Mahabadi AM, Modaresi SJ, Hamzeheil Z. Effect of Premedication with Indomethacin and Ibuprofen on Postoperative Endodontic Pain: A Clinical Trial. Iran Endod J. 2016 Winter;11(1):57-62. doi: 10.7508/iej.2016.01.011. Epub 2015 Dec 24.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf and 400mg starch in people with Acute Pulpitis, 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 9 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 13 Aug 2021. 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. 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?
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 after single endodontic visit (time frame: immediately and after 8,12,24,48 hours after completion endodontic treatment). 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 NCT04012424, which also lists 4 linked publications.
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 13 Aug 2021.