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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Cairo university

    Giza

Other trials in Egypt

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:

  1. Make sure the tooth is out of occlusion
  2. Hot saline mouth bath
  3. When pain is moderate /severe: Anti- inflammatory: ibuprofen600 tab/8hr (6)
  4. 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 groups in NCT04012424
Study groupRoleWhat they receive
Drug (400mg Curcumin) Curcumin is apiceExperimentalCurcumin 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 carbohydratesPlacebo comparatorpatints 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.

  1. 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)
  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.

  1. First posted9 Jul 2019
  2. Study start1 Aug 2019
  3. Primary completion1 Aug 2020
  4. Study completion1 Nov 2020

Resources

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)
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 2997245
  • Praveen 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 28320541
  • Arslan 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 21712619
  • Mokhtari 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

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.

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