NCT04035330

Brief 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 (MMP-9) postinstrumentation and pre-obturation

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

July 21, 2019

Last Update Submit

July 25, 2019

Conditions

Necrotic Pulp

Keywords

etidronatepostoperative painbacterial load reductionsodium hypochlorite irrigation

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    intensity of pain by Numerical rating scale from 0-10

    upto 48 hours after 1st visit

Secondary Outcomes (1)

  • bacterial load reduction

    1 hour after root canal preparation

Other Outcomes (1)

  • matrix metalloproteinase

    one week after root canal preparation

Study Arms (2)

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

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

Combination Product: sodium hypochlorite

Interventions

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

etidronate in sodium hypochlorite
sodium hypochloriteCOMBINATION_PRODUCT

irrigation with 25 ml 2.5% sodium hypochlorite . 5ml between each instrument.

sodium hypochlorite

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 27616541BACKGROUND

  • 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.

    PMID: 25515403BACKGROUND

  • 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.

    PMID: 19220516BACKGROUND

  • 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.

    PMID: 30993696BACKGROUND

  • 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.

    PMID: 22515905BACKGROUND

MeSH Terms

Conditions

Dental Pulp NecrosisPain, Postoperative

Interventions

Etidronic AcidSodium Hypochlorite

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsHypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Study Officials

  • Laila Z Ismail, M.Sc.

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Shaimaa I Gawdat, Ph.D

    Cairo University

    STUDY CHAIR

  • Randa El boghdadi, Ph.D

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Laila Z Ismail, M.Sc.

CONTACT

+201223487628laila.zakaria1990@gmail.com

Shaimaa I Gawdat, Ph.D

CONTACT

+201222235502Shaimaagawdat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 21, 2019

First Posted

July 29, 2019

Study Start

September 1, 2019

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

July 29, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share