Heating and Activation of Sodium HypochloriteNCT06461728
Minimal Instrumentation With Intracanal Heating and Activation of Sodium Hypochlorite for the Management of Teeth With Periapical Lesions
A study testing a new prototye device that heat and activate sodium hyochlorite (Aseptico) in people with Heating and Activation of Sodium Hypochlorite, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
this study is the first to demonstrate the efficacy of minimally invasive root canal treatment combined with intracanal heating and activation of NaOCl using a prototype needle on the healing of asymptomatic apical periodontitis of necrotic single rooted teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heating and Activation of Sodium Hypochlorite
- What is being tested?
- a new prototye device that heat and activate sodium hyochlorite (Aseptico)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteLebanon
- Study dates
- 7 Nov 2023to 7 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients without any known allergic reactions or systemic diseases.
- Single rooted teeth.
- Fully formed roots.
- The ability to place #15 hand file to working length (WL).
- Absence of canal calcifications.
- Absence of root fracture.
Show all 9Show fewer
- Absence of resorption.
- Teeth with pre-operative periapical radiolucency and PAI score ≥ 3 according to the classification of Ørstavik et al. 1986(20).
- Estimated WL 20-23mm.
Who cannot join
- Roots with broken or immature open apices.
- Roots presenting resorption.
- Patients younger than 18 years old.
- Pregnant patients.
- Teeth with previous root canal treatment.
- Teeth with calcified canals.
Show all 15Show fewer
- Teeth with two canals or any other anatomic variations.
- Root length less than 16 mm.
- Patients with chronic generalized periodontitis.
- Teeth with caries affecting the roots.
- Abnormal mobility of the tooth.
- Extensively restored and prepared teeth.
- Open apices.
- Previously root canal therapy.
- Root cracks.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Saint Joseph University
Beirut, 1481
fabienne R el Jagi, MSC, 70510337 ext. +961, fabienne.jagi@net.usj.edu.lb
roula H el hachem, Phd, 03836040 ext. +961, roula.hachem@usj.edu.lb
About this study
Official title: Minimal Instrumentation With Intracanal Heating ad Activation of Sodium Hypochlorite for
this study is the first to demonstrate the efficacy of minimally invasive root canal treatment combined with intracanal heating and activation of NaOCl using a prototype needle on the healing of asymptomatic apical periodontitis of necrotic single rooted teeth. 32 teeth will be randomaly assigned into 2 groups :conventional and conservative technique .In the conventional group : each canal will be prepared using Reciproc Blue 25/08, approximetly 27 ml of NaOCl will be used , the canal will be activated using 20.02 taper tip of a sonic decive . This cyclel will be repeated 3 times and the obturation will be done using a single cone technique with AH plus resin-based sealer . In the second group a size 10 k file will be introduced to confirm patency and to record working length after filling the canal with NaOCl. A glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. After the glide path, the canal will be irrigated with 3 ml of 5, 25 % of NaOCL .The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point , in order to heat and activate the irrigant solution for 30 seconds.Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time. Canals will be dried using sterile paper points size 15 and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2% tapered
Read the detailed description
32 single rooted teeth with pulp necrosis and asymptomatic apical periodontitis as confirmed by negative response to cold tests and the absence of bleeding on entering the pulp chamber also radiographs will be included in this study and the periapical status will be decided in accord with the periapical Index (PAI).
The endodontic procedure will be performed under strict aseptic settings and a dental operation microscopea. After confirming the clinical and radiological diagnosis, the access cavity will be performed using sterile round diamond ,then a size 10 FlexoFile (Dentsply, Maillfer, Ballaigues, Switzerland) will be introduced to confirm patency and to record working length after filling the canal with sodium hypochlorite.
Then a size 15 Flexofile (Dentsply,Maillfer,Ballaigues,Switzerland)will be introduced into the canal , only root canals with an initial apical size equivalent to 15 k file will be selected and roots with larger foramina will be excludedThen the teeth will be randomly assigned into two experimental groups(n=16): conventional or conservative technique.
Group 1: conventional rotary instrumentation. Each canal will be prepared using Reciproc Blue nickel titanium file 25/08 (VDW, Munich, Germany) according to the manufacturer's instructions. . Continuous checking of the canal patency will be done using size 10 hand file followed by irrigation with 3 ml of 5.25% sodium hypochlorite at room temperature using irriflex endodontic irrigation needle (Produits Dentaires SA, Vevey, Switzerland) mounted on a 3ml syringe (Plastipak, Franklin Lakes, NJ, USA). Each time the instrument will be removed out of the canal and before using the next instrument. Approximately, 27 ml of NaOCl will be used until Reciproc Blue reaches WL. Once the instrumentation is done, the canal will be irrigated with 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) keeping it in the canal for 3 minutes and then flushed with 5 ml of saline.
In the end, the canal will be filled with 5.25% NaOCl at room temperature and and activated using the size 20 .02 taper tip of a sonic device (EndoActivator, Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) at 10,000 cycles/min and the activator tip will be placed within 2 mm of the working length.
This cycle will be repeated three times and the canal will be rinsed with 3 ml of 5.25% NaOCl at room temperature after each cycle.
After the completion of the endodontic procedures, gauging of the apex will be done. The canals will be dried using sterile paper points size 25 (Maillfer,Ballaigues,Switzerland).
The obturation will be done using a single cone technique: AH plus resin-based sealer (Dentsply,DeTrey,Konstanz,Germany) will be mixed as per the manufacturer's instructions and applied to the root canal walls using a lentulo spiral also, the apical third of the gutta-percha size 25 (Maillfer,Baillaigues,Switzerland) will be coated with sealer and gently inserted into the canal to the working length. Excess of gutta-percha will be cut at the CEJ with a heat plugger (Fast-Pack pro-obturation system) and the coronal part of the gutta-percha will be condensed with gentle pressure using an endodontic plugger (Heat carrier Dentsply, Maillfer,Ballaigues,Switzerland).
Group 2: in the conservative technique, a size 10 FlexoFile (Dentsply,Maillfer,Ballaigues,Switzerland) will be introduced to confirm patency and to record working length after filling the canal with NaOCl. A glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. After the glide path, the canal will be irrigated with 3 ml of 5, 25 % of NaOCL at room temperature using irriflex endodontic needle (Produits Dentaires SA, Vevey, Switzerland) mounted on a 3ml syringe (Plastipak, Franklin Lakes, NJ, USA) .NaOCL is left in the canal and access cavity .The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point , in order to heat and activate the irrigant solution for 30 seconds . The tip will be moved with small (few mm) in-and out movement Than NaOCl will be aspirated from the canal and the access cavity than the canal will be filled with 17% EDTA, keeping it in the canal for 3 minutes followed by saline. Saline is aspirated. Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time. Canals will be dried using sterile paper points size 15 (Maillfer,Ballaigues,Switzerland) and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2% tapered (Dentsply,Maillfer,Ballaigues,Switzerland) .
- Being tested
- a new prototye device that heat and activate sodium hyochlorite (Aseptico)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a new prototye device that heat and activate sodium hyochlorite (Aseptico)Device
Also called Endoactivator (in the conventional group ) -Dentsply
endoactivator : it is a sonic activator device
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | Each canal will be prepared using Reciproc Blue nickel titanium file 25/08 and sonic activation of NaOCl Receives: Device: a new prototye device that heat and activate sodium hyochlorite (Aseptico) |
| conservative technique | Experimental | in the conservative technique, a size 10 FlexoFile will be introduced ,a glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen.
than heating and activation of NaOCl will be done with a prototype needle Receives: Device: a new prototye device that heat and activate sodium hyochlorite (Aseptico) |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficiency of minimal instrument combined with intracanal heating and activation of NaOCl
evaluation of the clinical and radiographic healing of minimally invasive root canal treatment performed with minimal instrumentation combined with intra-canal heating and activation of NaOCl using a prototype needle on necrotic single rooted tooth with apical periodontitis compared to conventional root canal treatment with sonic activation by comparing the change of the area of the lesion
Measured: 3 , 6 and 9 months follow up
Secondary outcomes (1)
To evaluate the speed of repair of healing periapical lesions
To evaluate the speed of repair of healing periapical lesions, using the following formulas:
Absolute speed of shrinkage (mm2/day) = ((initial detected area-final area))/(duration of treatment) Relative speed of shrinkage (per day)= ((initial detected area-final area) x 100)/(initial detected area x duration of the treatment )
Measured: 3,6 and 9 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start7 Nov 2023
- Primary completion7 Nov 2023
- Study completion7 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heating and Activation of Sodium HypochloriteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty-two single rooted teeth (N=32) with pulp necrosis and asymptomatic apical periodontitis
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461728
- Sponsor's protocol ID
- USJ-2023-266
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data will be shared with other researches if it is required or will help conducing further studies
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Instrumentation With Intracanal Heating ad Activation of Sodium Hypochlorite for
- ClinicalTrials.gov ID
- NCT06461728
- Acronym / sponsor ID
- USJ-2023-266
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Jun 2025 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study is the first to demonstrate the efficacy of minimally invasive root canal treatment combined with intracanal heating and activation of NaOCl using a prototype needle on the healing of asymptomatic apical periodontitis of necrotic single rooted teeth. 32 teeth will be randomaly assigned into 2 groups :conventional and conservative technique .In the conventional group : each canal will be prepared using Reciproc Blue 25/08, approximetly 27 ml of NaOCl will be used , the canal will be activated using 20.02 taper tip of a sonic decive . This cyclel will be repeated 3 times and the obturation will be done using a single cone technique with AH plus resin-based sealer . In the second group a size 10 k file will be introduced to confirm patency and to record working length after filling the canal with NaOCl. A glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. After the glide path, the canal will be irrigated with 3 ml of 5, 25 % of NaOCL .The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point , in order to heat and activate the irrigant solution for 30 seconds.Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time. Canals will be dried using sterile paper points size 15 and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2% tapered
Detailed description
32 single rooted teeth with pulp necrosis and asymptomatic apical periodontitis as confirmed by negative response to cold tests and the absence of bleeding on entering the pulp chamber also radiographs will be included in this study and the periapical status will be decided in accord with the periapical Index (PAI).
The endodontic procedure will be performed under strict aseptic settings and a dental operation microscopea. After confirming the clinical and radiological diagnosis, the access cavity will be performed using sterile round diamond ,then a size 10 FlexoFile (Dentsply, Maillfer, Ballaigues, Switzerland) will be introduced to confirm patency and to record working length after filling the canal with sodium hypochlorite.
Then a size 15 Flexofile (Dentsply,Maillfer,Ballaigues,Switzerland)will be introduced into the canal , only root canals with an initial apical size equivalent to 15 k file will be selected and roots with larger foramina will be excludedThen the teeth will be randomly assigned into two experimental groups(n=16): conventional or conservative technique.
Group 1: conventional rotary instrumentation. Each canal will be prepared using Reciproc Blue nickel titanium file 25/08 (VDW, Munich, Germany) according to the manufacturer's instructions. . Continuous checking of the canal patency will be done using size 10 hand file followed by irrigation with 3 ml of 5.25% sodium hypochlorite at room temperature using irriflex endodontic irrigation needle (Produits Dentaires SA, Vevey, Switzerland) mounted on a 3ml syringe (Plastipak, Franklin Lakes, NJ, USA). Each time the instrument will be removed out of the canal and before using the next instrument. Approximately, 27 ml of NaOCl will be used until Reciproc Blue reaches WL. Once the instrumentation is done, the canal will be irrigated with 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) keeping it in the canal for 3 minutes and then flushed with 5 ml of saline.
In the end, the canal will be filled with 5.25% NaOCl at room temperature and and activated using the size 20 .02 taper tip of a sonic device (EndoActivator, Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) at 10,000 cycles/min and the activator tip will be placed within 2 mm of the working length.
This cycle will be repeated three times and the canal will be rinsed with 3 ml of 5.25% NaOCl at room temperature after each cycle.
After the completion of the endodontic procedures, gauging of the apex will be done. The canals will be dried using sterile paper points size 25 (Maillfer,Ballaigues,Switzerland).
The obturation will be done using a single cone technique: AH plus resin-based sealer (Dentsply,DeTrey,Konstanz,Germany) will be mixed as per the manufacturer's instructions and applied to the root canal walls using a lentulo spiral also, the apical third of the gutta-percha size 25 (Maillfer,Baillaigues,Switzerland) will be coated with sealer and gently inserted into the canal to the working length. Excess of gutta-percha will be cut at the CEJ with a heat plugger (Fast-Pack pro-obturation system) and the coronal part of the gutta-percha will be condensed with gentle pressure using an endodontic plugger (Heat carrier Dentsply, Maillfer,Ballaigues,Switzerland).
Group 2: in the conservative technique, a size 10 FlexoFile (Dentsply,Maillfer,Ballaigues,Switzerland) will be introduced to confirm patency and to record working length after filling the canal with NaOCl. A glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. After the glide path, the canal will be irrigated with 3 ml of 5, 25 % of NaOCL at room temperature using irriflex endodontic needle (Produits Dentaires SA, Vevey, Switzerland) mounted on a 3ml syringe (Plastipak, Franklin Lakes, NJ, USA) .NaOCL is left in the canal and access cavity .The prototype needle tip will be placed in the canal to the length that is a little shorter than the length at binding point , in order to heat and activate the irrigant solution for 30 seconds . The tip will be moved with small (few mm) in-and out movement Than NaOCl will be aspirated from the canal and the access cavity than the canal will be filled with 17% EDTA, keeping it in the canal for 3 minutes followed by saline. Saline is aspirated. Step one is repeated 4 more times and a fresh solution of NaOCl is replaced every time. Canals will be dried using sterile paper points size 15 (Maillfer,Ballaigues,Switzerland) and the obturation will be performed for all teeth using the same technique as group 1 but with a standardized gutta percha point 2% tapered (Dentsply,Maillfer,Ballaigues,Switzerland) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Thirty-two single rooted teeth (N=32) with pulp necrosis and asymptomatic apical periodontitis
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Device: a new prototye device that heat and activate sodium hyochlorite (Aseptico)Each canal will be prepared using Reciproc Blue nickel titanium file 25/08 and sonic activation of NaOCl |
| conservative technique | Experimental | Device: a new prototye device that heat and activate sodium hyochlorite (Aseptico)in the conservative technique, a size 10 FlexoFile will be introduced ,a glide path will be established using the size 10 FlexoFile to the WL, than Proglider 16.02 to the foramen. than heating and activation of NaOCl will be done with a prototype needle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy patients without any known allergic reactions or systemic diseases.
- Single rooted teeth.
- Fully formed roots.
- The ability to place #15 hand file to working length (WL).
- Absence of canal calcifications.
Key exclusion criteria (15 listed)
- Roots with broken or immature open apices.
- Roots presenting resorption.
- Patients younger than 18 years old.
- Pregnant patients.
- Teeth with previous root canal treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a new prototye device that heat and activate sodium hyochlorite (Aseptico)Also: Endoactivator (in the conventional group ) -Dentsplyendoactivator : it is a sonic activator device | Device | conservative technique, conventional group |
Primary outcome
efficiency of minimal instrument combined with intracanal heating and activation of NaOCl
Time frame: 3 , 6 and 9 months follow up
evaluation of the clinical and radiographic healing of minimally invasive root canal treatment performed with minimal instrumentation combined with intra-canal heating and activation of NaOCl using a prototype needle on necrotic single rooted tooth with apical periodontitis compared to conventional root canal treatment with sonic activation by comparing the change of the area of the lesion
1 secondary outcome
To evaluate the speed of repair of healing periapical lesions
Time frame: 3,6 and 9 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Yes. Any data will be shared with other researches if it is required or will help conducing further studies
Related trials for Heating and Activation of Sodium Hypochlorite
Not yet recruitingPhase 1/2
Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of NaOCL
Necrotic Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a new prototye device that heat and activate sodium hyochlorite (Aseptico) in people with Heating and Activation of Sodium Hypochlorite, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabienne Roukoz El Jagi, MSc (70510337 ext. +961, fabienne.jagi@net.usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficiency of minimal instrument combined with intracanal heating and activation of NaOCl (time frame: 3 , 6 and 9 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.