NCT03537664

Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections

Completed NA Results posted Last updated 8 October 2020

What this trial tests

NA trial testing Root canal preparation in Periapical Periodontitis in 45 participants. Completed in 29 May 2020.

Timeline

4 August 2017

Primary endpoint
29 May 2020

29 May 2020

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	4 August 2017
Primary completion	29 May 2020
Estimated completion	29 May 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Root canal preparation
• Intracanal medication

Conditions studied

• Periapical Periodontitis — all drugs for Periapical Periodontitis →
• Bacterial Infections — all drugs for Bacterial Infections →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 65, any sex, with Periapical Periodontitis or Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Metabolic Activity of Persistent Bacteria Primary · 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.

Total bacteria at baseline (S1)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	4.748	± 6.2904

Total bacteria after root canal Preparation (S2)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	2.57	± 3.21

Total bacteria after adjunctive procedures (S3)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	2.614	± 2.978

Total bacteria after intracanal medication (S4)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	4.0008	± 4.374

Total bacteria after 2nd-visit preparation (S5)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	3.7875	± 2.9727

Bacteroidaceae sp. HOT-272 at S1

Group	Value	95% CI
Bacterial Species Analysis After Root Canal Preparation	1.136	± 0.1318

Bacteroidaceae sp. HOT-272 at S2

Group	Value	95% CI
Bacterial Species Analysis After Root Canal Preparation	1.123	± 0.1033

Cutibacterium acnes at S1

Group	Value	95% CI
Bacterial Species Analysis After Root Canal Preparation	1.411	± 0.3693

Bacterial Levels Secondary · 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).

Total bacteria at baseline (S1)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	178500	6210 – 2520000

Total bacteria after root canal Preparation (S2)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	7580	0 – 835000

Total bacteria after adjunctive procedures (S3)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	3815	0 – 184000

Total bacteria after intracanal medication (S4)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	15550	0 – 209000

Total bacteria after 2nd-visit preparation (S5)

Group	Value	95% CI
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures	0	0 – 96200

Bacteroidaceae sp. 272 at S1

Group	Value	95% CI
Bacterial Species Analysis After Root Canal Preparation	0	0 – 320000

Bacteroidaceae sp. 272 at S2

Group	Value	95% CI
Bacterial Species Analysis After Root Canal Preparation	0	0 – 12300

Cutibacterium acnes at S1

Group	Value	95% CI
Bacterial Species Analysis After Root Canal Preparation	0	0 – 17600

Bacterial Community Diversity Secondary · After 14 day treatment period

Composition of the active microbiome by Next Generation Sequencing (NGS) analysis of the root canal samples.

Firmicutes

Group	Value	95% CI
Bacterial Composition at Baseline	39.7
Bacterial Composition After Root Canal Preparation	39.8
Bacterial Composition After Intracanal Medication	39.8

Bacteroidetes

Group	Value	95% CI
Bacterial Composition at Baseline	39
Bacterial Composition After Root Canal Preparation	39.1
Bacterial Composition After Intracanal Medication	38.6

Proteobacteria

Group	Value	95% CI
Bacterial Composition at Baseline	15.8
Bacterial Composition After Root Canal Preparation	15.7
Bacterial Composition After Intracanal Medication	16

Actinobacteria

Group	Value	95% CI
Bacterial Composition at Baseline	1.4
Bacterial Composition After Root Canal Preparation	1.4
Bacterial Composition After Intracanal Medication	1.6

Spirochaetes

Group	Value	95% CI
Bacterial Composition at Baseline	0.7
Bacterial Composition After Root Canal Preparation	0.7
Bacterial Composition After Intracanal Medication	0.6

Endodontic Success Secondary · 1 year after endodontic treatment

Absence of clinical signs/ symptoms and reduction/ absence of apical radiolucency in radiologic examination

Group	Value	95% CI
Root Canal Preparation and Medication	19

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Contemporary Irrigant Activation Schemes and Subsequent Placement of an Interim Dressing on Bacterial Presence and Activity in Root Canals Associated with Asymptomatic Apical Periodontitis.
   Carvalho APL, Nardello LCL, Fernandes FS, Bruno FP, et al · · 2020 · cited 15× · PMID 32245051 · DOI 10.3390/jcm9030854