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

NCT04336709 | Completed Phase 2 DMC

• 1 other identifier: 2019-0304-3229
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Apical Periodontitis

Keywords

intracanal medicament; medicament removal; bacterial culture; efficacy; oil based medicament; colony forming unit

Outcome Measures

Primary Outcomes (1)

• Antimicrobial efficacy

  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

  7 days

Secondary Outcomes (1)

• Efficacy of intracanal medicament removal

  7 days

Study Arms (2)

Calcipex II

ACTIVE COMPARATOR

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

Metapex

ACTIVE COMPARATOR

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

Interventions

Calcipex II DRUG

Water based intracanal medicament

Calcipex II

Metapex DRUG

Oil based intracanal medicament

Metapex

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (5)

• Mozayeni MA, Haeri A, Dianat O, Jafari AR. Antimicrobial effects of four intracanal medicaments on enterococcus faecalis: an in vitro study. Iran Endod J. 2014 Summer;9(3):195-8. Epub 2014 Jul 5.

  PMID: 25031593 BACKGROUND

• Martinho FC, Gomes BP. Quantification of endotoxins and cultivable bacteria in root canal infection before and after chemomechanical preparation with 2.5% sodium hypochlorite. J Endod. 2008 Mar;34(3):268-72. doi: 10.1016/j.joen.2007.11.015. Epub 2008 Jan 31.

  PMID: 18291273 BACKGROUND

• Manzur A, Gonzalez AM, Pozos A, Silva-Herzog D, Friedman S. Bacterial quantification in teeth with apical periodontitis related to instrumentation and different intracanal medications: a randomized clinical trial. J Endod. 2007 Feb;33(2):114-8. doi: 10.1016/j.joen.2006.11.003.

  PMID: 17258626 BACKGROUND

• Gautam S, Rajkumar B, Landge SP, Dubey S, Nehete P, Boruah LC. Antimicrobial efficacy of metapex (calcium hydroxide with iodoform formulation) at different concentrations against selected microorganisms--an in vitro study. Nepal Med Coll J. 2011 Dec;13(4):297-300.

  PMID: 23016485 BACKGROUND

• Motiwala MA, Habib S, Ghafoor R, Irfan S. Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol. BMJ Open. 2021 Jul 21;11(7):e048947. doi: 10.1136/bmjopen-2021-048947.

  PMID: 34290069 DERIVED

MeSH Terms

Interventions

calcipex II; Metapex

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: April 6, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 4 months, as soon as we go by the steps till completion of study

Locations

PA (1)