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Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections

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ClinicalTrials.gov Identifier: NCT03537664
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ericka Tavares Pinheiro, University of Sao Paulo

Brief Summary:
This study aim to evaluate an endodontic treatment protocol using adjunctive steps for disinfection of teeth with primary endodontic infections.

Condition or disease Intervention/treatment Phase
Periapical Periodontitis Bacterial Infections Procedure: Root canal preparation Procedure: Intracanal medication Not Applicable

Detailed Description:
The success of endodontic treatment in teeth with necrotic pulp and apical periodontitis depends on the reduction of viable microorganisms of root canals by endodontic disinfection procedures. This study aims to evaluate by molecular methods the effect of different disinfection procedures on reduction, diversity and microbial metabolic activity. Patients with necrotic pulps and apical periodontitis in single-rooted teeth will be selected. Microbiological samples will be taken from root canals after access cavity (S1), after chemomechanical preparation with Reciproc System and 2.5% NaOCl (S2), after irrigant activation using the XP-Endo Finisher instrument (S3a) and ultrasonic activation (S3b); and after intracanal medication with calcium hydroxide for 14 days (S4). DNA and RNA will be extracted from root canal samples, and cDNA synthetized using reverse transcription reaction. The effect of treatment protocols on total microbiota will be determined by rDNA-based qPCR using universal primers for Bacteria domain. RNA of root canal samples will be used to determine the diversity of metabolically active microbiota by Reverse Transcriptase Reaction (RT), followed by amplification (PCR) and high throughput sequencing of the hypervariable region V1-V2-V3 of 16S rRNA gene. The metabolic activity of the most prevalent species / taxa will be calculated by rRNA- and rDNA-based molecular methods. The data will be analyzed by statistical tests, with 5% significance level.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of Metabolically Active Bacteria After Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections: RNA- and DNA-based Molecular Study
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Root canal preparation and medication
First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation. The second endodontic treatment includes the intracanal medication with calcium hydroxide paste.
Procedure: Root canal preparation
First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation.

Procedure: Intracanal medication
The second endodontic treatment includes the intracanal medication with calcium hydroxide paste.




Primary Outcome Measures :
  1. Metabolic activity of persistent bacteria [ Time Frame: Through study completion, an average of 2 years ]
    The metabolic activity of total bacteria and of the most prevalent species / taxa will be calculated by rRNA/ rDNA ratio estimated by qPCR using universal and species-specific primers.


Secondary Outcome Measures :
  1. Bacterial levels [ Time Frame: Through study completion, an average of 2 years ]
    Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay

  2. Bacterial community diversity [ Time Frame: Through study completion, an average of 2 years ]
    RNA will be used to determine the diversity of metabolically active microbiota by Reverse Transcriptase Reaction (RT), followed by amplification (PCR) and high throughput sequencing of the hypervariable region V1-V2-V3 of 16S rRNA gene.


Other Outcome Measures:
  1. Endodontic success [ Time Frame: Through study completion, an average of 2 years ]
    Absence of clinical signs/ symptoms and reduction/ absence of apical radiolucency in radiologic examination



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Teeth with necrotic pulps and asymptomatic apical periodontitis

Exclusion Criteria:

  • patients who had received antibiotics during the previous 3 months or had any general disease,
  • teeth that could not be properly isolated with rubber dam,
  • non-restored teeth,
  • periodontal pockets depths greater than 4 mm,
  • previous endodontic treatment,
  • open apex,
  • crown/root fracture
  • root resorption or calcifications.

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): NCT03537664


Contacts
Contact: Ericka T Pinheiro, PhD 551126488293 erickapinheiro@usp.br
Contact: Giulio Gavini, PhD 551126488025 ggavini@usp.br

Locations
Brazil
University of São Paulo Recruiting
São Paulo, Brazil, 05508000
Contact: Ericka T Pinheiro, PhD    551126488293    erickapinheiro@usp.br   
Contact: Giulio Gavini, PhD    551126488025    ggavini@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Ericka T Pinheiro, PhD University of São Paulo

Responsible Party: Ericka Tavares Pinheiro, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03537664     History of Changes
Other Study ID Numbers: FAPESP 2016/15473-0
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ericka Tavares Pinheiro, University of Sao Paulo:
Periapical Periodontitis
Bacterial Infections
Root Canal Preparation
Calcium Hydroxide
Real-Time Polymerase Chain Reaction
RNA-Directed DNA Polymerase

Additional relevant MeSH terms:
Infection
Communicable Diseases
Periodontitis
Bacterial Infections
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases