Effect of Etidronate in Sodium Hypochlorite Versus Sodium Hypochlorite on the Intensity of Postoperative Pain

July 25, 2019 updated by: Laila Zakaria Ismail, Cairo University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: etidronate in sodium hypochlorite
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
Combination product: etidronate in sodium hypochlorite
using etidronate in sodium hypochlorite solution with a volume of 5 ml between each instrument to reach a total volume of 25 ml
Active Comparator: sodium hypochlorite
irrigation with 2.5% NaOCl with a total volume of 25 ml for each case
Combination product: sodium hypochlorite
irrigation with 25 ml 2.5% sodium hypochlorite . 5ml between each instrument.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: upto 48 hours after 1st visit
intensity of pain by Numerical rating scale from 0-10
upto 48 hours after 1st visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacterial load reduction
Time Frame: 1 hour after root canal preparation
pre and post instrumentation samples to count intracanal bacteria (CFU/ml)
1 hour after root canal preparation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
matrix metalloproteinase
Time Frame: one week after root canal preparation
Periapical MMP-9 level will be determined by ELISA.
one week after root canal preparation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Laila Z Ismail, M.Sc., Cairo University
  • Study Chair: Shaimaa I Gawdat, Ph.D, Cairo University
  • Study Director: Randa El boghdadi, Ph.D, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETID_NAOCL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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