NCT04336709

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

Completed Phase 2, PHASE3 Last updated 29 July 2021

What this trial tests

Phase 2, PHASE3 trial testing Calcipex II in Chronic Apical Periodontitis in 60 participants. Completed in 30 April 2021.

Timeline

6 April 2020

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	Aga Khan University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	6 April 2020
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• Calcipex II — full drug profile →
• Metapex — full drug profile →

Conditions studied

• Chronic Apical Periodontitis — all drugs for Chronic Apical Periodontitis →

Sponsor

Aga Khan University

Who can join

Adults 18 to 60, any sex, with Chronic Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol.
   Motiwala MA, Habib S, Ghafoor R, Irfan S. · · 2021 · cited 2× · PMID 34290069 · DOI 10.1136/bmjopen-2021-048947
2. Comparison of Two Different Methods in the Removal of Oil-Based Calcium Hydroxide From Root Canal System: A Triple-Blinded Randomised Clinical Trial.
   Anis Motiwala M, Badar SB, Ghafoor R. · · 2021 · cited 2× · PMID 33907070 · DOI 10.14744/eej.2020.78941