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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Laila Z Ismail, M.Sc. contact

+201223487628

laila.zakaria1990@gmail.com

Shaimaa I Gawdat, Ph.D contact

+201222235502

Shaimaagawdat@gmail.com

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

  1. Anesthetizing the tooth using inferior alveolar nerve block technique by local anesthesia of 1.8 ml of 2% Mepivacaine with 1:100,000 epinephrine.
  2. Removal of caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
  3. 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.
  4. Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur.
  5. 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.
  6. 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).
  7. 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.
  8. 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.
  9. 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.
  10. 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)
  11. 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.
  12. The access cavities will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
  13. The patients will record their pain level on Visual analogue scale \& Numerical rating scale at 6,12, 24 and 48 hours.
  14. 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.
  15. The patients will be asked to record their pain level on VAS \& NRS at 6, 12, 24 and 48 hours .
  16. The details of the endodontic procedure for each patient will be recorded in the patient's procedure chart
  17. 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 groups in NCT04035330
Study groupRoleWhat they receive
etidronate in sodium hypochloriteExperimentalIt 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 hypochloriteActive comparatorirrigation 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.

  1. postoperative pain

    intensity of pain by Numerical rating scale from 0-10

    Measured: upto 48 hours after 1st visit

Secondary outcomes (1)
  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.

  1. First posted29 Jul 2019
  2. Study startSep 2019 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionSep 2021 (estimated)

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
34 participants (estimated)
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 27616541
  • Arias-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 25515403
  • Lottanti 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 19220516
  • Ballal 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 30993696
  • Paque 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

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.

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