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Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections

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ClinicalTrials.gov Identifier: NCT03537664
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ericka Tavares Pinheiro, University of Sao Paulo

Brief Summary:
This study aims 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), followed by 2nd-visit root canal preparation (S5). DNA and RNA will be extracted from root canal samples, and complementary DNA (cDNA) synthetized using reverse transcription reaction. The effect of treatment protocols on total microbiota levels will be determined by DNA-based quantitative polymerase chain reaction (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 V4-V5 of 16S rRNA gene. The metabolic activity of the most prevalent species / taxa will be calculated by rRNA- and DNA-based molecular methods. Ratios between rRNA and DNA levels will be calculated to search for active bacteria (rRNA/DNA ≥ 1) in root canal samples. Data will be analyzed by statistical tests, with 5% significance level.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
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
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Total bacteria analysis after 1rst- and 2nd-visit procedures
DNA levels and activity (RNA/DNA ratio) of total bacteria after the first-visit procedures (root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation) and the second-visit protocol (intracanal medication with calcium hydroxide paste, followed by an 2nd-visit root canal preparation). Additionally, the composition of the active microbiome will be assessed by Next Generation Sequencing (NGS) analysis of the root canal samples, and the success rate (apical repair) of the endodontic treatment after 1 follow-up period will be assessed by an intraoral radiograph and cone beam computed tomography (CBCT) analyses.
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, followed by an 2nd-visit root canal preparation

Bacterial species analysis after root canal preparation
DNA levels and activity (RNA/DNA ratio) of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation.Additionally, the success rate (apical repair) of the endodontic treatment after 1 follow-up period will be assessed by an intraoral radiograph and cone beam computed tomography (CBCT) analyses.
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.




Primary Outcome Measures :
  1. Metabolic Activity of Persistent Bacteria [ Time Frame: After 14 day treatment period ]
    The metabolic activity (rRNA/DNA ratio) of total bacteria, Bacteroidaceae sp. 272, Cutibacterium acnes, Selenomonas spp. and Enterococcus faecalis in root canal samples taken before and after endodontic procedures.


Secondary Outcome Measures :
  1. Bacterial Levels [ Time Frame: After 14 day treatment period ]
    Quantitative data of total bacteria, Bacteroidaceae sp. HOT-272, Cutibacterium acnes, Selenomonas spp. and Enterococcus faecalis determined by DNA-based qPCR (quantitative polymerase chain reaction).

  2. Bacterial Community Diversity [ Time Frame: After 14 day treatment period ]
    Composition of the active microbiome by Next Generation Sequencing (NGS) analysis of the root canal samples.


Other Outcome Measures:
  1. Endodontic Success [ Time Frame: 1 year after endodontic treatment ]
    Absence of clinical signs/ symptoms and reduction/ absence of apical radiolucency in radiologic examination



Information from the National Library of Medicine

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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


Locations
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Brazil
University of São Paulo
São Paulo, Brazil, 05508000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Ericka T Pinheiro, PhD University of São Paulo
  Study Documents (Full-Text)

Documents provided by Ericka Tavares Pinheiro, University of Sao Paulo:
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Responsible Party: Ericka Tavares Pinheiro, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03537664    
Other Study ID Numbers: FAPESP 2016/15473-0
First Posted: May 25, 2018    Key Record Dates
Results First Posted: October 8, 2020
Last Update Posted: October 8, 2020
Last Verified: September 2020

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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:
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Infection
Communicable Diseases
Bacterial Infections
Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases