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Comparison of Anti-microbial Efficacy of Calcipex and Metapex in Endodontic Treatment of Chronic Apical Periodontitis

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ClinicalTrials.gov Identifier: NCT04336709
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Momina Anis Motiwala, Aga Khan University

Brief Summary:

Introduction:

Pulpal necrosis may lead to spread of the infection from the pulp to involve the apex of the tooth and surrounding bone which when asymptomatic with periapical radiolucency on radiograph, is called chronic apical periodontitis. In order to eliminate the virulent bacteria and to overcome the inflammation in the root apex, endodontic treatment is the treatment of choice. Bacteria usually survive in the complex anatomy of the root canal system. In order to eliminate the remaining bacteria, various intracanal medicaments have been used widely however, there is controversy over their use and efficacy. Calcium hydroxide (CH) is the most commonly used intracanal medicament between root canal treatment sessions and available in different combinations. Multiple studies have been conducted to evaluate the effect of various types of CH based medicaments but whether CH with iodoform is more effective than CH alone against endodontic pathogens is a matter of controversy. In order to evaluate the true reduction in microbial load from the infected canals, microbial culture is a predictable and convenient tool.

Thus, this study aims to evaluate the antimicrobial effectiveness of inter-appointment intracanal medicament with either CH alone (Calcipex) or CH with iodoform (Metapex) for the treatment of infected root canals of teeth diagnosed with chronic apical periodontitis using colony forming unit (CFU).

Objective: To compare the anti-microbial efficacy of calcipex and metapex in endodontic treatment of teeth diagnosed with chronic apical periodontitis and to compare two different methods for removal of oil based intracanal medicaments.

Method: Approval from ERC is obtained. The selected subjects will be divided in to two study groups using a computer generated randomization list i.e., Group A - Calcipex group (n = 30) and Group B - Metapex group (n = 30). Two samples will be collected from the root canals for evaluation of microbial load after chemomechanical preparation (S1) (before use of intracanal medicament) and after usage of intra canal medicament (S2)(after 7 days).

Two techniques will be used for removal of oil based medicaments. Two radiographs will be obtained for each technique, after oil based medicament placement and after medicament removal for evaluation.

Data Analysis: Mean and standard deviation of continuous variable will be computed. Frequency distribution and proportion of categorical variables will be determined. Paired t-test will be used to assess difference bet¬ween antimicrobial efficacies within groups of medicaments. Independent sample t-test will be used to assess antimicrobial efficacies between groups. Level of significance will be kept at 0.05.

Mann whitney U test will be used to evaluate medicament removal between 2 groups and at three canal levels; coronal, middle and apical.


Condition or disease Intervention/treatment Phase
Chronic Apical Periodontitis Drug: Calcipex II Drug: Metapex Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: First visit: After chemomechanical preparation, irrigation and drying, a sterile paper point (size 20; EZ Endo, USA) will be inserted to the confirmed working length of the canal, and retained in position for 60 seconds for sampling (S1). Afterwards, the paperpoint will be gently removed and placed in an eppendorf tube (5 ml) containing Brain Heart Infusion Broth and sent directly to the microbiology laboratory for microbial cultivation. Respective intracanal medicament will be placed by means of lentulo spiral fillers and packed with a cotton pellet at the level of canal entrance. Access cavity will be filled with a temporary filling, Cavit-G. Second visit after 7 day, medicament will be removed. In case of Metapex (oil based medicament) either Protaper rotary or ultrasonic activation of file will be used for removal and radiograph obtained to ensure removal and sample will be obtained(S2). The canals will be then obturated. A definitive restoration will be placed subsequently.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: the participant or the care provider cannot be masked due to difference in colors of the medicaments, Metapex being yellow. The investigator (lab technician) and outcome assessor will be masked regarding the groups.
Primary Purpose: Treatment
Official Title: Comparison of Anti-microbial Efficacy of Calcipex and Metapex in Endodontic Treatment of Chronic Apical Periodontitis
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Calcipex II
Calcipex group Manufactures Nishika, Yamaguchi, Japan Color- White Formulation- Water based Duration- 7 days Form: Paste Frequency: Used once on 1st day only till canal fills. Composition- Water-based calcium hydroxide paste without radio contrast agent (Barium Sulfate) Packaging- (1 syringe of Calcipex Plain II (1.8g), 2 needles of Nishika Spin with 2 needle caps) Storage requirement- Room temperature (1-30℃).
Drug: Calcipex II
Water based intracanal medicament

Active Comparator: Metapex
Metapex group Manufactures- Meta Biomed, Korea Color- Yellow Formulation- Oil based Duration- 7 days Form: Paste Frequency: Used once on 1st day only till canal fills. Composition- Premixed oil-based paste composed of Calcium Hydroxide with Iodoform and silicon oil Packaging-2.2g paste in 1 syringe. 20 disposable tips. 1 ring rotator for direction control of the tip Storage requirement- Room temperature (1-30℃).
Drug: Metapex
Oil based intracanal medicament




Primary Outcome Measures :
  1. Antimicrobial efficacy [ Time Frame: 7 days ]
    antimicrobial efficacy of intracanal medicament as measuring using Colony forming unit/ml via bacterial culture. The higher CFU/ml suggests more bacterial colonies. We expect the counts to reduce after using the intracanal medicament


Secondary Outcome Measures :
  1. Efficacy of intracanal medicament removal [ Time Frame: 7 days ]

    Efficacy of intracanal medicament removal using four grade scoring system given by Khademi et al to evaluate amount of medicament remnant in the canal as seen and evaluated using periapical radiographs.

    GRADING:

    Removal efficacy 0 = the surface was not covered with calcium hydroxide

    1. = 1/3 of the surface was covered with calcium hydroxide
    2. = 2/3 of the surface was covered with calcium hydroxide
    3. = the surface was covered with calcium hydroxide completely Grade 0 and 1 will be taken as effective cleaning Grade 2 and 3 will be taken as non-effective cleaning



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Single rooted human permanent teeth
  • Single root canal clinically diagnosed with chronic apical periodontitis
  • No history of antibiotics use in last 3 months.

Exclusion Criteria:

  • Periodontally compromised teeth with Grade III mobility.
  • Endodontically non-salvageable teeth.
  • Immuno-compromised patients/systemic illness.
  • Excessive root resorption.
  • History of allergy to calcium hydroxide or iodoform.
  • Endodontic retreatment cases.

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): NCT04336709


Locations
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Pakistan
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Momina Anis Motiwala, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT04336709    
Other Study ID Numbers: 2019-0304-3229
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Everything will be managed and reported and collected and available for sharing to remove bias and ensure accurate conductance of study according to given protocols.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within 4 months, as soon as we go by the steps till completion of study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Momina Anis Motiwala, Aga Khan University:
intracanal medicament
medicament removal
bacterial culture
efficacy
oil based medicament
colony forming unit
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases