Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections

NCT03537664 | Completed Results DMC

• 1 other identifier: FAPESP 2016/15473-0
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate an endodontic treatment protocol using adjunctive steps for disinfection of teeth with primary endodontic infections.

Conditions

Periapical Periodontitis; Bacterial Infections

Keywords

Periapical Periodontitis; Bacterial Infections; Root Canal Preparation; Calcium Hydroxide; Real-Time Polymerase Chain Reaction; RNA-Directed DNA Polymerase

Outcome Measures

Primary Outcomes (1)

• Metabolic Activity of Persistent Bacteria

  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.

  After 14 day treatment period

Secondary Outcomes (2)

• Bacterial Levels

  After 14 day treatment period

• Bacterial Community Diversity

  After 14 day treatment period

Other Outcomes (1)

• Endodontic Success

  1 year after endodontic treatment

Study Arms (2)

Total bacteria analysis after 1rst- and 2nd-visit procedures

EXPERIMENTAL

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; Procedure: Intracanal medication

Bacterial species analysis after root canal preparation

OTHER

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

Interventions

Root canal preparation PROCEDURE

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.

Bacterial species analysis after root canal preparation; Total bacteria analysis after 1rst- and 2nd-visit procedures

Intracanal medication PROCEDURE

The second endodontic treatment includes the intracanal medication with calcium hydroxide paste, followed by an 2nd-visit root canal preparation

Total bacteria analysis after 1rst- and 2nd-visit procedures

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Teeth with necrotic pulps and asymptomatic apical periodontitis

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

São Paulo, 05508000, Brazil

Location

MeSH Terms

Conditions

Periapical Periodontitis; Bacterial Infections

Interventions

Root Canal Preparation

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry; Tooth Preparation

Results Point of Contact

• Title: Dr. Ericka Pinheiro
• Organization: University of Sao Paulo

erickapinheiro@usp.br

551126488293

Study Officials

• Ericka T Pinheiro, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: August 4, 2017
• Primary Completion: May 29, 2020
• Study Completion: May 29, 2020
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-09

Locations

BR (1)