Necrotic PulpNCT04035330
Effect of Etidronate in Sodium Hypochlorite Versus Sodium Hypochlorite on the Intensity of Postoperative Pain
A study testing etidronate in sodium hypochlorite and sodium hypochlorite in people with Necrotic Pulp, run by Cairo University.
Trial summary
To compare the effect of using Etidronate in sodium hypochlorite versus sodium hypochlorite irrigating solution on: Postoperative pain in patients with necrotic pulp. Bacterial load reduction \& main bacterial species detected preinstrumentation and post-instrumentaion Periapical Matrix metalloproteinase 9 level… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- etidronate in sodium hypochlorite and sodium hypochlorite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2021
- 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
- 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.
- Mandibular permanent premolar teeth:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain
- Slight widening in the periodontal membrane space or with a periapical radiolucency
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
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 24 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.
Show all 11Show fewer
- Greater than grade I mobility or pocket depth greater than 5 mm. Need special surgical and/or periodontal therapy.
- Hopeless tooth.
- Vital teeth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Using Etidronate in Sodium Hypochlorite Versus Sodium Hypochlorite Irrigating Solution on the Intensity of Postoperative Pain and Bacterial Load Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial
To compare the effect of using Etidronate in sodium hypochlorite versus sodium hypochlorite irrigating solution on:
- Postoperative pain in patients with necrotic pulp.
- Bacterial load reduction \& main bacterial species detected preinstrumentation and post-instrumentaion
- Periapical Matrix metalloproteinase 9 level (MMP-9) postinstrumentation and pre-obturation
Read the detailed description
Patients will be clinically and radiographically examined and their eligibility will be assessed Eligible patients will be treated in 2 visits
- Anesthetizing the tooth using inferior alveolar nerve block technique by local anesthesia of 1.8 ml of 2% Mepivacaine with 1:100,000 epinephrine.
- Removal of caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Cleaning the operative field, including the tooth, the clamp, and rubber dam sheet, with 30% hydrogen peroxide until no further bubbling of the peroxide occurred. All surfaces will then be disinfected by a sterile cotton swab with a 5.25% sodium hypochlorite solution.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur.
- After completing the access, the operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above. NaOCl will be then neutralized with 5% sodium thiosulfate.
- The patients will be randomly divided into 2 groups. Intervention group (9% Etidronate in 2.5% sodium hypochlorite root canal irrigant /Dual rinse) and control group (2.5% sodium hypochlorite root canal irrigant).
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15. Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex. The canals to be enlarged to size #20.
- The pre-instrumentation root canal sample (S1) as follows: a sterile paper point will be placed in the wider /largest canal to soak up the fluid in the canal with saline to a level approximately 1 mm short of the tooth apex based on diagnostic radiographs and estimated working length. The paper point will be left in the canal for at least 1 minute. Paper points will then be transferred aseptically to tubes containing 20 ml of sterile thioglycollate broth.
- Mechanical preparation will be done using M PRO rotary files in an endodontic motor.The first file (18/.09) will be used as an orifice opener for two thirds of the working length followed by (20/.04) for the full working length and finally (25/.06). In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established working length. The first file is used with a continuous rotary motion at a speed of 500 rpm and torque of 3 Ncm. The second and third files are both used with a speed of 500 rpm and torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- The canals will be thoroughly irrigated with the allocated irrigant (5ml for 1 min) using plastic disposable syringe with needle gauge 30 reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (25 ml)
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate followed by 5 ml distilled water to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canal as described above. In addition, the periapical sample (S3) will be collected after cleaning and shaping by introducing a fine sterile size 20 paper point 2 mm beyond the canal terminus for 1 min. This procedure was performed twice. The paper points were placed in a sterile micro-centrifugation tube (Merck) containing 2 mL of sterile physiological saline solution, and immediately transferred to a -80 °C freezer until further processing.
- The access cavities will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
- The patients will record their pain level on Visual analogue scale \& Numerical rating scale at 6,12, 24 and 48 hours.
- In the recall appointment after 1 week. Rubber dam will be applied and tooth will be disinfected as before. The previously sampled canal will be re-entered, flushing with saline and a second periapical sample (S4) will be taken. After the sampling, final flush with 2.5% NaOCL and 17% Ethylene diamine tetraacetic acid (EDTA) in the control group, and with 2.5% NaOCL and 9% Etidronate in the intervention group. Master cones of (0.40) taper gutta-percha will be fitted to the working length and a radiograph will be taken to ensure proper length. Obturation using resin-based root canal sealer. The access cavity will be restored with composite resin and occlusal contact will be checked.
- The patients will be asked to record their pain level on VAS \& NRS at 6, 12, 24 and 48 hours .
- The details of the endodontic procedure for each patient will be recorded in the patient's procedure chart
- Finally, the patient will be appointed after 48 hours to collect the outcome data.
- Conditions
- Necrotic Pulp
- Being tested
- etidronate in sodium hypochlorite, sodium hypochlorite
- Keywords
- etidronate, postoperative pain, bacterial load reduction, sodium hypochlorite irrigation
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etidronate in sodium hypochloriteCombination product
using etidronate in sodium hypochlorite solution with a volume of 5 ml between each instrument to reach a total volume of 25 ml
sodium hypochloriteCombination product
irrigation with 25 ml 2.5% sodium hypochlorite . 5ml between each instrument.
| Study group | Role | What they receive |
|---|---|---|
| etidronate in sodium hypochlorite | Experimental | It comes in a capsule containing 0.9 g of etidronate powder, which should be mixed immediately with 10 mL of a NaOCl solution of choice directly before treatment, resulting in a combined irrigant containing both active chlorine and approximately 9% etidronate. Irrigation with a total volume of 25 ml for each case Receives: Combination Product: etidronate in sodium hypochlorite |
| sodium hypochlorite | Active comparator | irrigation with 2.5% NaOCl with a total volume of 25 ml for each case Receives: Combination Product: sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
intensity of pain by Numerical rating scale from 0-10
Measured: upto 48 hours after 1st visit
Secondary outcomes (1)
bacterial load reduction
pre and post instrumentation samples to count intracanal bacteria (CFU/ml)
Measured: 1 hour after root canal preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study startSep 2019 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laila Zakaria Ismail, Cairo University
- Investigators
- Laila Z Ismail, M.Sc., Principal investigator, Cairo UniversityShaimaa I Gawdat, Ph.D, Study chair, Cairo UniversityRanda El boghdadi, Ph.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035330
- Sponsor's protocol ID
- ETID_NAOCL
- Status last verified
- Jul 2019
- First submitted
- 21 Jul 2019
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morago A, Ordinola-Zapata R, Ferrer-Luque CM, Baca P, Ruiz-Linares M, Arias-Moliz MT. Influence of Smear Layer on the Antimicrobial Activity of a Sodium Hypochlorite/Etidronic Acid Irrigating Solution in Infected Dentin. J Endod. 2016 Nov;42(11):1647-1650. doi: 10.1016/j.joen.2016.07.023. Epub 2016 Sep 8.
PubMed 27616541Arias-Moliz MT, Ordinola-Zapata R, Baca P, Ruiz-Linares M, Garcia Garcia E, Hungaro Duarte MA, Monteiro Bramante C, Ferrer-Luque CM. Antimicrobial activity of Chlorhexidine, Peracetic acid and Sodium hypochlorite/etidronate irrigant solutions against Enterococcus faecalis biofilms. Int Endod J. 2015 Dec;48(12):1188-93. doi: 10.1111/iej.12424. Epub 2015 Jan 8.
PubMed 25515403Lottanti S, Gautschi H, Sener B, Zehnder M. Effects of ethylenediaminetetraacetic, etidronic and peracetic acid irrigation on human root dentine and the smear layer. Int Endod J. 2009 Apr;42(4):335-43. doi: 10.1111/j.1365-2591.2008.01514.x. Epub 2009 Feb 7.
PubMed 19220516Ballal NV, Gandhi P, Shenoy PA, Shenoy Belle V, Bhat V, Rechenberg DK, Zehnder M. Safety assessment of an etidronate in a sodium hypochlorite solution: randomized double-blind trial. Int Endod J. 2019 Sep;52(9):1274-1282. doi: 10.1111/iej.13129. Epub 2019 May 13.
PubMed 30993696Paque F, Rechenberg DK, Zehnder M. Reduction of hard-tissue debris accumulation during rotary root canal instrumentation by etidronic acid in a sodium hypochlorite irrigant. J Endod. 2012 May;38(5):692-5. doi: 10.1016/j.joen.2011.12.019. Epub 2012 Jan 23.
PubMed 22515905
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Etidronate in Sodium Hypochlorite Versus Sodium Hypochlorite Irrigating Solution on the Intensity of Postoperative Pain and Bacterial Load Reduction in Patients With Necrotic Pulp: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04035330
- Acronym / sponsor ID
- ETID_NAOCL
- Conditions
- Necrotic Pulp
- Keywords
- etidronate, postoperative pain, bacterial load reduction, sodium hypochlorite irrigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 29 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.
To compare the effect of using Etidronate in sodium hypochlorite versus sodium hypochlorite irrigating solution on:
- Postoperative pain in patients with necrotic pulp.
- Bacterial load reduction \& main bacterial species detected preinstrumentation and post-instrumentaion
- Periapical Matrix metalloproteinase 9 level (MMP-9) postinstrumentation and pre-obturation
Detailed description
Patients will be clinically and radiographically examined and their eligibility will be assessed Eligible patients will be treated in 2 visits
- Anesthetizing the tooth using inferior alveolar nerve block technique by local anesthesia of 1.8 ml of 2% Mepivacaine with 1:100,000 epinephrine.
- Removal of caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Cleaning the operative field, including the tooth, the clamp, and rubber dam sheet, with 30% hydrogen peroxide until no further bubbling of the peroxide occurred. All surfaces will then be disinfected by a sterile cotton swab with a 5.25% sodium hypochlorite solution.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur.
- After completing the access, the operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above. NaOCl will be then neutralized with 5% sodium thiosulfate.
- The patients will be randomly divided into 2 groups. Intervention group (9% Etidronate in 2.5% sodium hypochlorite root canal irrigant /Dual rinse) and control group (2.5% sodium hypochlorite root canal irrigant).
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15. Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex. The canals to be enlarged to size #20.
- The pre-instrumentation root canal sample (S1) as follows: a sterile paper point will be placed in the wider /largest canal to soak up the fluid in the canal with saline to a level approximately 1 mm short of the tooth apex based on diagnostic radiographs and estimated working length. The paper point will be left in the canal for at least 1 minute. Paper points will then be transferred aseptically to tubes containing 20 ml of sterile thioglycollate broth.
- Mechanical preparation will be done using M PRO rotary files in an endodontic motor.The first file (18/.09) will be used as an orifice opener for two thirds of the working length followed by (20/.04) for the full working length and finally (25/.06). In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established working length. The first file is used with a continuous rotary motion at a speed of 500 rpm and torque of 3 Ncm. The second and third files are both used with a speed of 500 rpm and torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- The canals will be thoroughly irrigated with the allocated irrigant (5ml for 1 min) using plastic disposable syringe with needle gauge 30 reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (25 ml)
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate followed by 5 ml distilled water to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canal as described above. In addition, the periapical sample (S3) will be collected after cleaning and shaping by introducing a fine sterile size 20 paper point 2 mm beyond the canal terminus for 1 min. This procedure was performed twice. The paper points were placed in a sterile micro-centrifugation tube (Merck) containing 2 mL of sterile physiological saline solution, and immediately transferred to a -80 °C freezer until further processing.
- The access cavities will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
- The patients will record their pain level on Visual analogue scale \& Numerical rating scale at 6,12, 24 and 48 hours.
- In the recall appointment after 1 week. Rubber dam will be applied and tooth will be disinfected as before. The previously sampled canal will be re-entered, flushing with saline and a second periapical sample (S4) will be taken. After the sampling, final flush with 2.5% NaOCL and 17% Ethylene diamine tetraacetic acid (EDTA) in the control group, and with 2.5% NaOCL and 9% Etidronate in the intervention group. Master cones of (0.40) taper gutta-percha will be fitted to the working length and a radiograph will be taken to ensure proper length. Obturation using resin-based root canal sealer. The access cavity will be restored with composite resin and occlusal contact will be checked.
- The patients will be asked to record their pain level on VAS \& NRS at 6, 12, 24 and 48 hours .
- The details of the endodontic procedure for each patient will be recorded in the patient's procedure chart
- Finally, the patient will be appointed after 48 hours to collect the outcome data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etidronate in sodium hypochlorite | Experimental | Combination Product: etidronate in sodium hypochloriteIt comes in a capsule containing 0.9 g of etidronate powder, which should be mixed immediately with 10 mL of a NaOCl solution of choice directly before treatment, resulting in a combined irrigant containing both active chlorine and approximately 9% etidronate. Irrigation with a total volume of 25 ml for each case |
| sodium hypochlorite | Active comparator | Combination Product: sodium hypochloriteirrigation with 2.5% NaOCl with a total volume of 25 ml for each case |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Mandibular permanent premolar teeth:
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
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 24 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:
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 |
|---|---|---|
| etidronate in sodium hypochloriteusing etidronate in sodium hypochlorite solution with a volume of 5 ml between each instrument to reach a total volume of 25 ml | Combination product | etidronate in sodium hypochlorite |
| sodium hypochloriteirrigation with 25 ml 2.5% sodium hypochlorite . 5ml between each instrument. | Combination product | sodium hypochlorite |
Primary outcome
postoperative pain
Time frame: upto 48 hours after 1st visit
intensity of pain by Numerical rating scale from 0-10
1 secondary outcome
bacterial load reduction
Time frame: 1 hour after root canal preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Background: PubMed 27616541Morago A, Ordinola-Zapata R, Ferrer-Luque CM, Baca P, Ruiz-Linares M, Arias-Moliz MT. Influence of Smear Layer on the Antimicrobial Activity of a Sodium Hypochlorite/Etidronic Acid Irrigating Solution in Infected Dentin. J Endod. 2016 Nov;42(11):1647-1650. doi: 10.1016/j.joen.2016.07.023. Epub 2016 Sep 8.
- Background: PubMed 25515403Arias-Moliz MT, Ordinola-Zapata R, Baca P, Ruiz-Linares M, Garcia Garcia E, Hungaro Duarte MA, Monteiro Bramante C, Ferrer-Luque CM. Antimicrobial activity of Chlorhexidine, Peracetic acid and Sodium hypochlorite/etidronate irrigant solutions against Enterococcus faecalis biofilms. Int Endod J. 2015 Dec;48(12):1188-93. doi: 10.1111/iej.12424. Epub 2015 Jan 8.
- Background: PubMed 19220516Lottanti S, Gautschi H, Sener B, Zehnder M. Effects of ethylenediaminetetraacetic, etidronic and peracetic acid irrigation on human root dentine and the smear layer. Int Endod J. 2009 Apr;42(4):335-43. doi: 10.1111/j.1365-2591.2008.01514.x. Epub 2009 Feb 7.
- Background: PubMed 30993696Ballal NV, Gandhi P, Shenoy PA, Shenoy Belle V, Bhat V, Rechenberg DK, Zehnder M. Safety assessment of an etidronate in a sodium hypochlorite solution: randomized double-blind trial. Int Endod J. 2019 Sep;52(9):1274-1282. doi: 10.1111/iej.13129. Epub 2019 May 13.
- Background: PubMed 22515905Paque F, Rechenberg DK, Zehnder M. Reduction of hard-tissue debris accumulation during rotary root canal instrumentation by etidronic acid in a sodium hypochlorite irrigant. J Endod. 2012 May;38(5):692-5. doi: 10.1016/j.joen.2011.12.019. Epub 2012 Jan 23.
- Individual participant dataSharing planned: No
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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.
Laila Z Ismail, M.Sc. principal investigator
Cairo University
Shaimaa I Gawdat, Ph.D study chair
Cairo University
Randa El boghdadi, Ph.D study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing etidronate in sodium hypochlorite 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 7 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: status not confirmed, as of the sponsor's last update on 29 Jul 2019. 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 Laila Z Ismail, M.Sc. (+201223487628, laila.zakaria1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: upto 48 hours after 1st visit). 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 NCT04035330, which also lists 5 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 29 Jul 2019.