Necrotic PulpNCT04728386
Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin or Sodium Hypochlorite
A study testing curcumin solution and sodium hypochlorite in people with Necrotic Pulp, run by Cairo University.
Trial summary
This study aims to compare the effect of 2% curcumin solution versus 2.5% sodium hypochlorite as irrigating solutions in necrotic mandibular molars in terms of postoperative pain and antibacterial effect. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- curcumin solution and sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Mar 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age between 18-50 years.
- Male and female.
- Systemically healthy patients (ASA I or II).
- Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions
Who cannot join
- Medically compromised patients having substantive functional limitations (ASA III or IV).
- Patients having two or more adjacent teeth requiring endodontic treatment.
- Patients who received antibiotic therapy within the last three months before treatment.
- Patients administered analgesics in the last 24 hours before treatment.
- Teeth with:
- Vital pulps.
Show all 13Show fewer
- Immature apices.
- Acute periapical abscess, swellings and facial cellulitis.
- Periodontally hopeless (mobility grade II or III).
- Previous root canal treatment.
- Non-restorable coronal portion.
- TMJ problems, bruxism or traumatic occlusion.
- Inability to perceive the given instructions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin Versus Sodium Hypochlorite in Patients With Necrotic Mandibular Molars: Randomized Clinical Trial
This study aims to compare the effect of 2% curcumin solution versus 2.5% sodium hypochlorite as irrigating solutions in necrotic mandibular molars in terms of postoperative pain and antibacterial effect.
Read the detailed description
patients with necrotic mandibular molars will be selected
- Diagnostic procedures:
- Personal information (name, age, gender, address and phone number), full medical and dental histories using schematic charts will be obtained from all patients participating in this research.
- History of chief complaint will be obtained in the dental history chart.
- Clinical and radiographic evaluation for each tooth included in this study will be recorded. The tooth will be examined for presence of extensive caries or pulp exposures. Soft tissue examination and tooth mobility evaluation will be done by percussion and palpation.
- Extraoral examination will be performed by visual inspection of the face and neck and palpation for any swollen lymph nodes.
- Each tooth will be evaluated for sensitivity using electric pulp tester. Diagnosis will also be confirmed by the absence of bleeding after access cavity preparation.
- Final Diagnosis: Mature mandibular asymptomatic necrotic molars with normal periapical radiographic appearance.
- The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrollment.
- Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading using a Numerical Rating Scale (NRS).
- Endodontic procedures:
- All the performed steps of root canal treatment will be included in the chart of endodontic procedures.
- The tooth will be isolated with rubber dam to maintain aseptic field, after isolation the tooth and surrounding field will be disinfected by a protocol using 3% hydrogen peroxide and 2.5% sodium hypochlorite before and after coronal access cavity preparation.
- The initial sample S1 will be collected from root canals before preparation using sterile paper points. Each root canal will be dried with 3 sterile paper points ISO# 15 which will be left inside the root canal for 1 minute each with pumping movements to generate a suspension with bacteria of the main pulpal area.
- The paper points will be immediately placed in sterile test tubes containing reduced transport medium of thioglycolate and sent to the Microbiology Laboratory, Faculty of Medicine, Cairo University for microbiologic processing to be cultured within one hour.
- Root canals will be mechanically prepared in a crown-down approach using ProTaper Universal NiTi files in an X-Smart endodontic motor according to the manufacture instructions.
- The canals will be thoroughly irrigated between every two subsequent files using 2 ml of 2.5% NaOCl using a side vented needle (gauge 29) to control the possibility of irrigant apical extrusion.
- After complete root canal preparation all canals will be flushed with 17 % EDTA followed by sterile saline.
- Random allocation:
- According to the randomization sequence, after complete root canal preparation patients will be assigned to one of 2 groups:
- Intervention Group (G1): each canal will be flushed using 5 ml of curcumin solution in a plastic syringe with a side vented needle (gauge 29) inserted 1 ml shorter than the working length.
- Comparator Group (G2): each canal will be flushed using 5 ml of 2.5% sodium hypochlorite in a plastic syringe with side vented needle (gauge 29) inserted 1 ml shorter than the working length.
- After flushing the canals with each irrigating solution all canals will be flushed with 10 ml sterile saline and the final sample S2 will be collected in the same manner as S1 using sterile paper points ISO # 30/0.02 or # 40/0.02, corresponding to the size of the master apical file F3 or F4, respectively.
- Root canals will be dried using ProTaper paper points. The root canals will be obturated using the modified single cone technique with resin based root canal sealer and ProTaper gutta-percha cones size F3 or F4 according to the size of the final finishing file, together with auxiliary cones ISO # 25/0.02.
- After obturation, a cotton pellet will be placed in the pulp chamber and the access cavity will be sealed with a temporary filling.
- All patients will be asked to record their postoperative pain level on Numerical Rating Scale (NRS) at 8, 24 and 48 hours postoperatively.
- Conditions
- Necrotic Pulp
- Being tested
- curcumin solution, sodium hypochlorite
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin solutionOther
2 % curcumin solution as root canal irrigant
sodium hypochloriteOther
2.5% sodium hypochlorite solution as root canal irrigant
| Study group | Role | What they receive |
|---|---|---|
| curcumin irrigant | Experimental | final flush root canal irrigation with 5 ml curcumin solution Receives: Other: curcumin solution |
| sodium hypochlorite | Experimental | final flush root canal irrigation with 5 ml sodium hypochlorite Receives: Other: sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain at 8 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
- 0 = no pain.
- 1-3= mild pain.
- 4-6= moderate pain.
- 7-10= severe pain. scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
- 0 = no pain.
- 1-3= mild pain.
- 4-6= moderate pain.
- 7-10=severe pain
Measured: 8 hours
postoperative pain at 24 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
Measured: 24 hours
postoperative pain at 48 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
Measured: 48 hours
Secondary outcomes (1)
antibacterial effect
assessment through culture and the count of Colony-Forming Units(CFUs)
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Medhat, Cairo University
- Investigators
- eman medhat, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728386
- Sponsor's protocol ID
- CU-ENDO-11-10-2020
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.
PubMed 30815731Sotomil JM, Munchow EA, Pankajakshan D, Spolnik KJ, Ferreira JA, Gregory RL, Bottino MC. Curcumin-A Natural Medicament for Root Canal Disinfection: Effects of Irrigation, Drug Release, and Photoactivation. J Endod. 2019 Nov;45(11):1371-1377. doi: 10.1016/j.joen.2019.08.004. Epub 2019 Sep 18.
PubMed 31542283Purohit RN, Bhatt M, Purohit K, Acharya J, Kumar R, Garg R. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):37-40. doi: 10.5005/jp-journals-10005-1404. Epub 2017 Feb 27.
PubMed 28377653
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin Versus Sodium Hypochlorite in Patients With Necrotic Mandibular Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04728386
- Acronym / sponsor ID
- CU-ENDO-11-10-2020
- Conditions
- Necrotic Pulp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 Jan 2021 (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.
This study aims to compare the effect of 2% curcumin solution versus 2.5% sodium hypochlorite as irrigating solutions in necrotic mandibular molars in terms of postoperative pain and antibacterial effect.
Detailed description
patients with necrotic mandibular molars will be selected
- Diagnostic procedures:
- Personal information (name, age, gender, address and phone number), full medical and dental histories using schematic charts will be obtained from all patients participating in this research.
- History of chief complaint will be obtained in the dental history chart.
- Clinical and radiographic evaluation for each tooth included in this study will be recorded. The tooth will be examined for presence of extensive caries or pulp exposures. Soft tissue examination and tooth mobility evaluation will be done by percussion and palpation.
- Extraoral examination will be performed by visual inspection of the face and neck and palpation for any swollen lymph nodes.
- Each tooth will be evaluated for sensitivity using electric pulp tester. Diagnosis will also be confirmed by the absence of bleeding after access cavity preparation.
- Final Diagnosis: Mature mandibular asymptomatic necrotic molars with normal periapical radiographic appearance.
- The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrollment.
- Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading using a Numerical Rating Scale (NRS).
- Endodontic procedures:
- All the performed steps of root canal treatment will be included in the chart of endodontic procedures.
- The tooth will be isolated with rubber dam to maintain aseptic field, after isolation the tooth and surrounding field will be disinfected by a protocol using 3% hydrogen peroxide and 2.5% sodium hypochlorite before and after coronal access cavity preparation.
- The initial sample S1 will be collected from root canals before preparation using sterile paper points. Each root canal will be dried with 3 sterile paper points ISO# 15 which will be left inside the root canal for 1 minute each with pumping movements to generate a suspension with bacteria of the main pulpal area.
- The paper points will be immediately placed in sterile test tubes containing reduced transport medium of thioglycolate and sent to the Microbiology Laboratory, Faculty of Medicine, Cairo University for microbiologic processing to be cultured within one hour.
- Root canals will be mechanically prepared in a crown-down approach using ProTaper Universal NiTi files in an X-Smart endodontic motor according to the manufacture instructions.
- The canals will be thoroughly irrigated between every two subsequent files using 2 ml of 2.5% NaOCl using a side vented needle (gauge 29) to control the possibility of irrigant apical extrusion.
- After complete root canal preparation all canals will be flushed with 17 % EDTA followed by sterile saline.
- Random allocation:
- According to the randomization sequence, after complete root canal preparation patients will be assigned to one of 2 groups:
- Intervention Group (G1): each canal will be flushed using 5 ml of curcumin solution in a plastic syringe with a side vented needle (gauge 29) inserted 1 ml shorter than the working length.
- Comparator Group (G2): each canal will be flushed using 5 ml of 2.5% sodium hypochlorite in a plastic syringe with side vented needle (gauge 29) inserted 1 ml shorter than the working length.
- After flushing the canals with each irrigating solution all canals will be flushed with 10 ml sterile saline and the final sample S2 will be collected in the same manner as S1 using sterile paper points ISO # 30/0.02 or # 40/0.02, corresponding to the size of the master apical file F3 or F4, respectively.
- Root canals will be dried using ProTaper paper points. The root canals will be obturated using the modified single cone technique with resin based root canal sealer and ProTaper gutta-percha cones size F3 or F4 according to the size of the final finishing file, together with auxiliary cones ISO # 25/0.02.
- After obturation, a cotton pellet will be placed in the pulp chamber and the access cavity will be sealed with a temporary filling.
- All patients will be asked to record their postoperative pain level on Numerical Rating Scale (NRS) at 8, 24 and 48 hours postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcumin irrigant | Experimental | Other: curcumin solutionfinal flush root canal irrigation with 5 ml curcumin solution |
| sodium hypochlorite | Experimental | Other: sodium hypochloritefinal flush root canal irrigation with 5 ml sodium hypochlorite |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's age between 18-50 years.
- Male and female.
- Systemically healthy patients (ASA I or II).
- Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions
Key exclusion criteria (13 listed)
- Medically compromised patients having substantive functional limitations (ASA III or IV).
- Patients having two or more adjacent teeth requiring endodontic treatment.
- Patients who received antibiotic therapy within the last three months before treatment.
- Patients administered analgesics in the last 24 hours before treatment.
- Teeth with:
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 solution2 % curcumin solution as root canal irrigant | Other | curcumin irrigant |
| sodium hypochlorite2.5% sodium hypochlorite solution as root canal irrigant | Other | sodium hypochlorite |
Primary outcome
postoperative pain at 8 hours
Time frame: 8 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows: * 0 = no pain. * 1-3= mild pain. * 4-6= moderate pain. * 7-10= severe pain. scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows: * 0 = no pain. * 1-3= mild pain. * 4-6= moderate pain. * 7-10=severe pain
postoperative pain at 24 hours
Time frame: 24 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
postoperative pain at 48 hours
Time frame: 48 hours
recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:
1 secondary outcome
antibacterial effect
Time frame: during treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Background: PubMed 30815731Yilmaz K, Tufenkci P, Adiguzel M. The effects of QMix and EndoActivator on postoperative pain in mandibular molars with nonvital pulps: a randomized clinical trial. Clin Oral Investig. 2019 Nov;23(11):4173-4180. doi: 10.1007/s00784-019-02856-6. Epub 2019 Feb 27.
- Background: PubMed 31542283Sotomil JM, Munchow EA, Pankajakshan D, Spolnik KJ, Ferreira JA, Gregory RL, Bottino MC. Curcumin-A Natural Medicament for Root Canal Disinfection: Effects of Irrigation, Drug Release, and Photoactivation. J Endod. 2019 Nov;45(11):1371-1377. doi: 10.1016/j.joen.2019.08.004. Epub 2019 Sep 18.
- Background: PubMed 28377653Purohit RN, Bhatt M, Purohit K, Acharya J, Kumar R, Garg R. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study. Int J Clin Pediatr Dent. 2017 Jan-Mar;10(1):37-40. doi: 10.5005/jp-journals-10005-1404. Epub 2017 Feb 27.
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Pulp Necrosis, Apical Periodontitis
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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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.
eman medhat principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing curcumin solution and sodium hypochlorite in people with Necrotic Pulp, 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 4 inclusion and 13 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 28 Jan 2021. 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?
Contact eman medhat (01276054444, emanmedhat10@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain at 8 hours (time frame: 8 hours). The study lists 3 primary outcomes in all. 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 NCT04728386, which also lists 3 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 28 Jan 2021.