Blood Contamination of Root Canal During Endodontic Therapy
Conditions
Brief summary
Blood contamination, such as apical microleakage, of root canal during preparation can be a major problem in endodontics. The purpose of this investigation was to evaluate the hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in teeth with irreversible pulpitis.
Detailed description
A new device (HYBENX®) has been developed with the purpose of destroying dental biofilm. The material contains a concentrated aqueous mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%). The investigators planned a clinical and microbiological study using the decontaminant device in order to destroy the dental biofilm of root canals in cases of irreversible pulpitis. The ability of the decontaminant device to immediately stop bleeding during canal instrumentation was found out accidentally during the procedures of this still unpublished trial. Due to this fact, the investigators were interested in evaluating the coagulation property of the material. Therefore, the aim of this prospective study is to describe a new approach to obtain hemostasis during root canal therapy using a sulfonic/sulfuric acid solution. A total of 15 teeth with irreversible and acute pulpitis were included in the study. After manual and mechanical instrumentation of the root canal, a sterile paper point was introduced in the canal, and a first score was given based on the blood quantity. The solution was used to irrigate the bleeding root canal; then a second sterile paper point was introduced, and the same score was assessed. The null hypothesis was that there is no difference in root canal bleeding before and after the use of the solution (⎧=0)
Interventions
DEVICEHYBENX®
The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement. Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.
Sponsors
Dr Riccardo Pace
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* tooth affected by irreversible pulpitis, single-rooted teeth associated with healthy periodontium, physiologic sulcus depth (\<3 mm), and absence of bleeding on probing of the involved teeth.
Exclusion criteria
* patients with systemic diseases using anticoagulants, antibiotics, or anti-inflammatory therapies in the last 30 days, patients with allergy to sulfur in any form, and pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Root Canal Bleeding Score | 20 sec - before and after use | After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence. The root canal bleeding score (RCBS) was given as follows: * 0: no blood detected * 1: blood detected in the apical third of the root canal * 2: blood detected both in the apical and the middle thirds of the root canal * 3: blood detected in the whole root canal. After the use of the material a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood and an RCBS was assessed according the previous criteria |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HYBENX® 1 cc of mixture of hydroxybenzenesulfonic acid (37%) and hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%) for 20 sec
HYBENX®: The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.
Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | HYBENX® |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Region of Enrollment Italy | 15 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change From Baseline in Root Canal Bleeding Score
After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence. The root canal bleeding score (RCBS) was given as follows: * 0: no blood detected * 1: blood detected in the apical third of the root canal * 2: blood detected both in the apical and the middle thirds of the root canal * 3: blood detected in the whole root canal. After the use of the material a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood and an RCBS was assessed according the previous criteria
Time frame: 20 sec - before and after use
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HYBENX® | Change From Baseline in Root Canal Bleeding Score | Before use | 2.33 score on a scale | Standard Deviation 0.724 |
| HYBENX® | Change From Baseline in Root Canal Bleeding Score | After use | 0.13 score on a scale | Standard Deviation 0.352 |
p-value: <0.0001Wilcoxon signed-rank test