Trial Outcomes & Findings for Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections (NCT NCT03537664)
NCT ID: NCT03537664
Last Updated: 2020-10-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
After 14 day treatment period
Results posted on
2020-10-08
Participant Flow
Samples from 20 patients were used for the analysis of total bacteria in 1st and 2nd visits. Additional 25 patients were necessary for the analysis of specific bacterial species in post-instrumentation samples (n=45 patients).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
25
|
|
Overall Study
Metabolic Activity of Bacteria
|
15
|
25
|
|
Overall Study
Bacterial Levels
|
20
|
25
|
|
Overall Study
Bacterial Community Diversity
|
10
|
0
|
|
Overall Study
Endodontic Success
|
20
|
10
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections
Baseline characteristics by cohort
| Measure |
Root Canal Preparation and Medication
n=45 Participants
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.
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.
Intracanal medication: The second endodontic treatment includes the intracanal medication with calcium hydroxide paste.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
41 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=93 Participants
|
|
Region of Enrollment
Brazil
|
45 participants
n=93 Participants
|
|
Number of participants with infected root canals
|
45 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: After 14 day treatment periodPopulation: There was a lost of RNA samples from 5 cases.
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.
Outcome measures
| Measure |
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures
n=15 Participants
RNA/DNA ratio of total bacteria after the first- and second-visit treatment (active bacteria with rRNA/DNA ≥ 1). 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 for 14 days, followed by an 2nd-visit root canal preparation.
|
Bacterial Species Analysis After Root Canal Preparation
n=20 Participants
RNA/DNA ratio of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation (active bacteria with rRNA/DNA ≥ 1).
|
Bacterial Composition After Intracanal Medication
Microbiome analysis in post-medication samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
|
|---|---|---|---|
|
Metabolic Activity of Persistent Bacteria
Total bacteria at baseline (S1)
|
4.748 RNA/DNA ratio
Standard Deviation 6.2904
|
—
|
—
|
|
Metabolic Activity of Persistent Bacteria
Total bacteria after root canal Preparation (S2)
|
2.57 RNA/DNA ratio
Standard Deviation 3.21
|
—
|
—
|
|
Metabolic Activity of Persistent Bacteria
Total bacteria after adjunctive procedures (S3)
|
2.614 RNA/DNA ratio
Standard Deviation 2.978
|
—
|
—
|
|
Metabolic Activity of Persistent Bacteria
Total bacteria after intracanal medication (S4)
|
4.0008 RNA/DNA ratio
Standard Deviation 4.374
|
—
|
—
|
|
Metabolic Activity of Persistent Bacteria
Total bacteria after 2nd-visit preparation (S5)
|
3.7875 RNA/DNA ratio
Standard Deviation 2.9727
|
—
|
—
|
|
Metabolic Activity of Persistent Bacteria
Bacteroidaceae sp. HOT-272 at S1
|
—
|
1.136 RNA/DNA ratio
Standard Deviation 0.1318
|
—
|
|
Metabolic Activity of Persistent Bacteria
Bacteroidaceae sp. HOT-272 at S2
|
—
|
1.123 RNA/DNA ratio
Standard Deviation 0.1033
|
—
|
|
Metabolic Activity of Persistent Bacteria
Cutibacterium acnes at S1
|
—
|
1.411 RNA/DNA ratio
Standard Deviation 0.3693
|
—
|
|
Metabolic Activity of Persistent Bacteria
Cutibacterium acnes at S2
|
—
|
1.489 RNA/DNA ratio
Standard Deviation 0.3547
|
—
|
|
Metabolic Activity of Persistent Bacteria
Selenomonas spp. at S1
|
—
|
1.092 RNA/DNA ratio
Standard Deviation 0.09859
|
—
|
|
Metabolic Activity of Persistent Bacteria
Selenomonas spp. at S2
|
—
|
1 RNA/DNA ratio
Standard Deviation 0
|
—
|
|
Metabolic Activity of Persistent Bacteria
Enterococcus faecalis at S1
|
—
|
0.7433 RNA/DNA ratio
Standard Deviation 0.1882
|
—
|
|
Metabolic Activity of Persistent Bacteria
Enterococcus faecalis at S2
|
—
|
0 RNA/DNA ratio
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: After 14 day treatment periodPopulation: There was a lost of RNA samples from 5 cases
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).
Outcome measures
| Measure |
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures
n=20 Participants
RNA/DNA ratio of total bacteria after the first- and second-visit treatment (active bacteria with rRNA/DNA ≥ 1). 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 for 14 days, followed by an 2nd-visit root canal preparation.
|
Bacterial Species Analysis After Root Canal Preparation
n=20 Participants
RNA/DNA ratio of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation (active bacteria with rRNA/DNA ≥ 1).
|
Bacterial Composition After Intracanal Medication
Microbiome analysis in post-medication samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
|
|---|---|---|---|
|
Bacterial Levels
Total bacteria at baseline (S1)
|
178500 DNA copies (Bacterial levels)
Interval 6210.0 to 2520000.0
|
—
|
—
|
|
Bacterial Levels
Total bacteria after root canal Preparation (S2)
|
7580 DNA copies (Bacterial levels)
Interval 0.0 to 835000.0
|
—
|
—
|
|
Bacterial Levels
Total bacteria after adjunctive procedures (S3)
|
3815 DNA copies (Bacterial levels)
Interval 0.0 to 184000.0
|
—
|
—
|
|
Bacterial Levels
Total bacteria after intracanal medication (S4)
|
15550 DNA copies (Bacterial levels)
Interval 0.0 to 209000.0
|
—
|
—
|
|
Bacterial Levels
Total bacteria after 2nd-visit preparation (S5)
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 96200.0
|
—
|
—
|
|
Bacterial Levels
Bacteroidaceae sp. 272 at S1
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 320000.0
|
—
|
|
Bacterial Levels
Bacteroidaceae sp. 272 at S2
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 12300.0
|
—
|
|
Bacterial Levels
Cutibacterium acnes at S1
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 17600.0
|
—
|
|
Bacterial Levels
Cutibacterium acnes at S2
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 41400.0
|
—
|
|
Bacterial Levels
Selenomonas spp. at S1
|
—
|
4090 DNA copies (Bacterial levels)
Interval 0.0 to 347000.0
|
—
|
|
Bacterial Levels
Selenomonas spp. at S2
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 3980.0
|
—
|
|
Bacterial Levels
Enterococcus faecalis at S1
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 125000.0
|
—
|
|
Bacterial Levels
Enterococcus faecalis at S2
|
—
|
0 DNA copies (Bacterial levels)
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: After 14 day treatment periodPopulation: Root canal samples from 10 patients were included in the sequencing analysis.
Composition of the active microbiome by Next Generation Sequencing (NGS) analysis of the root canal samples.
Outcome measures
| Measure |
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures
n=10 Participants
RNA/DNA ratio of total bacteria after the first- and second-visit treatment (active bacteria with rRNA/DNA ≥ 1). 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 for 14 days, followed by an 2nd-visit root canal preparation.
|
Bacterial Species Analysis After Root Canal Preparation
n=10 Participants
RNA/DNA ratio of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation (active bacteria with rRNA/DNA ≥ 1).
|
Bacterial Composition After Intracanal Medication
n=10 Participants
Microbiome analysis in post-medication samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
|
|---|---|---|---|
|
Bacterial Community Diversity
Firmicutes
|
39.7 relative abundance of phyla (percentage)
|
39.8 relative abundance of phyla (percentage)
|
39.8 relative abundance of phyla (percentage)
|
|
Bacterial Community Diversity
Bacteroidetes
|
39 relative abundance of phyla (percentage)
|
39.1 relative abundance of phyla (percentage)
|
38.6 relative abundance of phyla (percentage)
|
|
Bacterial Community Diversity
Proteobacteria
|
15.8 relative abundance of phyla (percentage)
|
15.7 relative abundance of phyla (percentage)
|
16 relative abundance of phyla (percentage)
|
|
Bacterial Community Diversity
Actinobacteria
|
1.4 relative abundance of phyla (percentage)
|
1.4 relative abundance of phyla (percentage)
|
1.6 relative abundance of phyla (percentage)
|
|
Bacterial Community Diversity
Spirochaetes
|
0.7 relative abundance of phyla (percentage)
|
0.7 relative abundance of phyla (percentage)
|
0.6 relative abundance of phyla (percentage)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year after endodontic treatmentPopulation: A subset of 30 patients had both intra-oral radiograph and cone beam computed tomography (CBCT) scans for analysis of the treatment outcome. After 1 year, 8 patients were lost during the follow-up period and 22 patients were analysed.
Absence of clinical signs/ symptoms and reduction/ absence of apical radiolucency in radiologic examination
Outcome measures
| Measure |
Total Bacteria Analysis After 1rst- and 2nd-visit Procedures
n=22 Participants
RNA/DNA ratio of total bacteria after the first- and second-visit treatment (active bacteria with rRNA/DNA ≥ 1). 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 for 14 days, followed by an 2nd-visit root canal preparation.
|
Bacterial Species Analysis After Root Canal Preparation
RNA/DNA ratio of Bacteroidaceae sp. 272 , Cutibacterium acnes, Selenomonas spp., and Enterococcus faecalis after root canal preparation (active bacteria with rRNA/DNA ≥ 1).
|
Bacterial Composition After Intracanal Medication
Microbiome analysis in post-medication samples by Next Generation Sequencing (NGS) based on RNA (cDNA).
|
|---|---|---|---|
|
Endodontic Success
|
19 Participants
|
—
|
—
|
Adverse Events
Root Canal Preparation and Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place