Clinical trial NCT03853200: Comparison of Antibacterial Efficacy of Three Final Irrigants
Official title: In-vivo Comparison of Antibacterial Efficacy of Three Different Solutions as Final Irrigant During Endodontic Therapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endodontic Disease
Root Canal Infection
Keywords: Final irrigation
Irrigation in Endodontics
QMix
CFU
Colony forming unit
MRS
Microbiological root canal sampling
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to determine the antibacterial affect of three different solutions used as final irrigant during endodontic therapy. The investigator's objective was to compare the antibacterial affect of relatively new final irrigant QMix with EDTA and Qmix with EDTA+CHX by evaluating the bacteriological status of the root canal before and after use of the final irrigant.

Detailed description: The aim of this clinical trial is to compare the antibacterial efficacy of Qmix, to 17% EDTA+ Chlorhexidine and 17% EDTA, used as final irrigants, during endodontic procedure.

Endodontic treatment was carried out on 90 necrosed teeth of patients under rubber dam isolation and strict sterilization protocol. The teeth were divided into three groups; A, B and C depending on the type of final irrigant to be used. The chemo-mechanical preparation of all the 90 samples was carried out using ProTaper Universal (Dentsply) File system, and 3% sodium Hypochlorite. All the samples from each group were then irrigated according to the final rinse protocol (FRP). Group A was irrigated with Qmix; Group B with 17% EDTA + 2% Chlorhexidine and Group C (Control group) 17% EDTA.

Three bacteriologic samples were taken during the procedure from each root canal under study in all three groups, using sterile paper points. Sample A was collected after access cavity opening and negotiation of the canal but before chemo-mechanical preparation. Sample B was taken after chemo-mechanical preparation but before the use of the final irrigant. Sample C was collected after the use of final irrigation solution. The samples were collected with sterile paper points and were then transferred to microbiology laboratory in microtubes containing Brain Heart Infusion (BHI) broth within 2 hours of sample collection for obtaining the colony forming unit (CFU) counts.

Eligibility criteria: Inclusion Criteria:

* Teeth:

  * Single rooted (One root canal)
  * Necrosed teeth requiring root canal treatment.
  * Teeth with mature apices
  * Permanent dentition
  * Mandibular \& Maxillary
  * PAI category 1 to 4

Exclusion Criteria:

• Teeth:

* Single rooted teeth with multiple canals
* Root canal treated
* Requiring elective endodontic therapy
* With partial necrosis
* Fractured
* Having calcified and obliterated canals.
* Having root resorption
* Root canals which could not be negotiated to full working length with #10 K file
* Having severe periodontitis with exacerbating features (PAI = 5)
* Having grade III mobility
* Patients who took systemic antibiotics in past four weeks.

Primary outcomes:
measure: Change in Colony forming Unit
timeFrame: Before and after use of final irrigant, up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Hasan Zaidi
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Hasan Zaidi, BDS
role: PRINCIPAL_INVESTIGATOR
References: