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Effect of Hebal and Synthetic Medicamentss on Enterococcus Feacalis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06006663
Recruitment Status : Not yet recruiting
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
Alaa Essam Ahmed Abo Laimon, Tanta University

Study Description
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Brief Summary:
this study aims to evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases.

Condition or disease Intervention/treatment Phase
Effective Intracanal Medicaments Against Enterococcus Faecalis Drug: Ibuprofen 400 mg. Drug: modified triple antibiotic paste Dietary Supplement: curcumin Dietary Supplement: olive leaves extract Phase 2 Phase 3

Detailed Description:

we evaluate the antimicrobial efficacy of two synthetic (Ibuprofen, Modified triple antibiotic paste) and two herbal materials (Curcumin and Olive leaves extract) used as intracanal medication, against E.Faecalis in secondary endodontic infection cases by taking three samples from root canal , the first sample after removing gutta percha from root canal system, the second sample after shaping with protaper universal files and cleaning with 2.5% sodium hypochlorite , the third sample after 7 days from application of the medication .

samples will be diluted into ten fold serial dilution and then the diluted samples will be cultured on bile esculin agar as it is selective media for enterococcus feacalis.

bacterial reduction will be determined and comparision will be made .

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Antimicrobial Efficacy of Synthetic Versus Herbal Intracanal Medicaments Against Enterococcus Faecalis
Estimated Study Start Date : August 26, 2023
Estimated Primary Completion Date : October 5, 2023
Estimated Study Completion Date : December 10, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: group 1
ibuprofen as intracanal medicament
 Drug: Ibuprofen 400 mg.
synthetic intracanal medicament
Active Comparator: group 2
modified triple antibiotic paste as intracanal medicament
 Drug: modified triple antibiotic paste
synthetic intracanal medicament
Other Name: clindamycin, ciprofloxacin and metronidazole
Active Comparator: group 3
curcumin as intracanal medicament
 Dietary Supplement: curcumin
herbal intracanal medicament
Active Comparator: group 4
olive leaves as intracanal medicament
 Dietary Supplement: olive leaves extract
herbal intracanal medicament


Outcome Measures
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Primary Outcome Measures :
  1. measurment of microbial reduction as result of applying synthetic and herbaal intracanal medicaments [ Time Frame: time necessary for incubation of each sample is 24 hour ]
    sample 1 will be taken after gutta percha removal sample 2 will be taken after cleaning and shaping sample 3 will be taken after apllying the intracanal medicament for one week


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Single rooted teeth.
  • Teeth have clinical signs and symptoms of endodontic failure as sensitivity to percussion, pain, swelling or fistula.
  • Teeth with radiographic features of endodontic failure as persistent periapical lesion or widening of periodontal ligament.

Exclusion Criteria:

  • • Teeth with fractures of the crown or root.

    • Teeth with periodontal pocket deeper than 4mm.
    • Teeth have procedural error like ledge, broken instrument, or perforation.
Contacts and Locations
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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): NCT06006663


Contacts
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Contact: alaa essam abo laimon, demonstrator at university 01005690958 alaalamona@yahoo.com

Sponsors and Collaborators
Tanta University
More Information
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Responsible Party: Alaa Essam Ahmed Abo Laimon, Demonstrator , Endodontic department,Faculty of dentistry,Tanta university, Tanta University
ClinicalTrials.gov Identifier: NCT06006663    
Other Study ID Numbers: eliminations of E.faecalis
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Metronidazole
Ciprofloxacin
Clindamycin
Ibuprofen
Curcumin
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Protein Synthesis Inhibitors