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Effect of Irrigation With Antibiotic-containing Solutions on Postoperative Pain and Intra-canal Bacteria

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ClinicalTrials.gov Identifier: NCT04035070
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Information provided by (Responsible Party):
Michel Karam Eissa Elias, Cairo University

Brief Summary:
• The aim of this study is to compare the degree of postoperative pain and the antimicrobial effect in terms of bacterial count reduction after using co-amoxiclav-clindamycin solution versus MTAD and sodium hypochlorite irrigating solutions in patients with necrotic pulp.

Condition or disease Intervention/treatment Phase
Necrotic Pulp Combination Product: co-amoxiclav-clindamycin solution Combination Product: MTAD Combination Product: 2.5% sodium hypochlorite Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial)
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Root canal irrigation with co-amoxiclav-clindamycin solution
Alternate irrigation with 1 mL antibiotic-containing solution followed by 4 mL 2.5% sodium hypochlorite solution between each size instrument and the consequent one. The antibiotic-containing solution will be prepared by mixing equal quantities of 1.2 gm Co-amoxiclav solution and 600 mg Clindamycin solution at a ratio of 1:1 by volume.
Combination Product: co-amoxiclav-clindamycin solution
antibiotic-containing solution will be prepared by mixing equal quantities of 1.2gm Co-amoxiclav solution and 600mg Clindamycin solution at a ratio of 1:1 by volume to be used as a root canal irrigating solution

Experimental: Root canal irrigation with MTAD
Irrigation with 5 mL MTAD irrigating solution for 5 minutes between each size instrument and the consequent one.
Combination Product: MTAD
mixture of 3% doxycycline hyclate, 4.25% citric acid and detergent (Tween 80) to be used as a root canal irrigating solution
Other Name: BioPure MTAD

Active Comparator: Root canal irrigation with 2.5% sodium hypochlorite
Irrigation with 5 mL 2.5% sodium hypochlorite irrigating solution between each size instrument and the consequent one.
Combination Product: 2.5% sodium hypochlorite
It will be prepared by adding 10mL of sterile distilled water to 10mL of 5.25% sodium hypochlorite solution to be used as a root canal irrigating solution




Primary Outcome Measures :
  1. postoperative pain: numerical rating scale [ Time Frame: up to 48 hours after the first visit ]
    intensity of pain by numerical rating scale from 0 to 10


Secondary Outcome Measures :
  1. intra-canal bacterial count [ Time Frame: 72 hours after root canal preparation ]
    pre and post-instrumentation samples to count intra-canal bacteria (CFU/mL)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Maxillary/mandibular single-rooted permanent teeth:

    • Diagnosed clinically with pulp necrosis.
    • Absence of spontaneous pain.
    • Normal/slight widening in the periodontal membrane space (PMS).
  • Patients' acceptance to participate in the trial.
  • Patients who can understand numerical rating scale (NRS) and can sign the informed consent.

Exclusion Criteria:

  • Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients show higher incidence of pain and lower healing rate.
  • Patients with known allergy to penicillin or penicillin derivatives.
  • Pregnant females: 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 show 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 5mm. Need special surgical and/or periodontal therapy.
  • Non-restorable teeth.
  • Immature teeth.
  • Radiographic evidence of periapical radiolucency, external or internal root resorption, vertical root fracture, perforation or calcification.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035070


Contacts
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Contact: Michel K Elias, M.Sc. +2 0122 553 5090 michel.karam.5@gmail.com
Contact: Heba El-Asfouri, Ph.D. +2 0100 527 6232 heba.elasfouri@dentistry.cu.edu.eg

Locations
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Egypt
Endodontic Department - Faculty of Dentistry - Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Michel K Elias, M.Sc. faculty of dentistry Cairo university
Study Director: Maged M Negm, Ph.D. faculty of dentistry Cairo university
Study Chair: Heba El-Asfouri, Ph.D. faculty of dentistry Cairo university

Publications:

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Responsible Party: Michel Karam Eissa Elias, Assistant lecturer at endodontic department - School of dentistry - New Giza University, Cairo University
ClinicalTrials.gov Identifier: NCT04035070     History of Changes
Other Study ID Numbers: CEBC-CU-2019-10-145
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Michel Karam Eissa Elias, Cairo University:
antibiotic-containg solution
co-amoxiclav-clindamycin solution
MTAD
sodium hypochlorite
postoperative pain
antimicrobial efficacy
root canal irrigation
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dental Pulp Necrosis
Pain, Postoperative
Necrosis
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Sodium Hypochlorite
Eusol
Pharmaceutical Solutions
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Disinfectants
beta-Lactamase Inhibitors