Irrigation ActivationNCT06660797
Irrigation Activating Techniques on Irrigant Penetration Depth and Microbial Reduction
A study testing Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal., Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute and Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation. in people with Irrigation Activation and Endodontic Disease, run by Tanta University at 1 site in Egypt.
Trial summary
This in-vivo study aim to evaluate effect of different irrigation activating techniques on Irrigant Penetration Depth and Microbial Reduction in root Canals Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irrigation Activation, Endodontic Disease
- What is being tested?
- Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal., Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute and Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Asymptomatic vital/non vital teeth requiring root canal treatment.
- Teeth with sound periodontal apparatus.
- Teeth without pus or inflammatory exudates draining through the canal.
- Teeth without anatomic variations.
- Teeth with sinus tract.
Who cannot join
- • Patients with any systemic diseases.
- Pregnant or lactating patients.
- Immunocompromised patients.
- Apparently thin roots in which apical preparation with #40 or #50 file would be overzealous.
- Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
- Retreatment cases. Teeth with calcified canals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Tanta
yara fawzy, master, +201113674317
About this study
Official title: Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and Microbial Reduction in Root Canals (Clinical Study)
This in-vivo study aim to evaluate effect of different irrigation activating techniques on Irrigant Penetration Depth and Microbial Reduction in root Canals
Read the detailed description
Chemomechanical preparation with removal of infected tissues and microbial biofilms is the corner stone of root canal treatment. Since mechanical instrumentation alone cannot adequately disinfect root canals, complete cleaning and shaping involves irrigation with chemicals together with mechanical instrumentation.
In addition to shaping the root canal, the aim of chemical-mechanical preparation of root canals is to eliminate vital or necrotic tissue, microorganisms and their products, and dentin debris that result from instrumentation. However, the complexity of root canal anatomy together with microbial infection hinder this purpose.
Primary endodontic infection is characterized by the presence of a wide range of microbial diversity dominated by anaerobes. The polymicrobial profile of pulp infection involves both Gram-positive and Gram-negative bacterial species.
Besides, the apical third of the root canal system typically has a complex morphology and is difficult to clean. So, it is important to bring irrigants into contact with the entire canal surfaces along its total micro anatomic complexity for effective action especially in the apical portions .
Irrigating solutions used during endodontic handling act through direct contact with the targeted bacteria. However, irrigants have inadequate penetration depth. It is highly desirable that chemical substances selected as endodontic irrigants have antimicrobial and organic tissue dissolution properties besides serving in the debridement of the root canal system and not being toxic to the tissues .Sodium hypochlorite (NaOCl) has been the gold standard for irrigation because of its ability to dissolve organic matter and high antimicrobial potential.
Conventional needle irrigation is the most commonly employed technique for delivering irrigants into the root canal system. However, the disadvantage of conventional needle irrigation is its passive action, and inability to deliver solutions into the narrow anatomical features of the root canal system. Despite the high success rates of root canal treatment, reducing the bacterial load below the level that is required to assure healing has become the accepted goal. Hence, several irrigant activation systems have been developed to increase the effectiveness of irrigation by providing energy within the canal to disperse and move the irrigant around the canal system in anticipation of them removing biofilm more effectively.
Therefore, various activation and agitation systems have been introduced to improve the irrigation penetration and effectiveness. These systems include manual dynamic agitation, sonic, passive ultrasonic, photon initiated photoacoustic streaming (PIPS), laser, XP-endo Finisher file, and Easy-Clean (EC).
The XP-endo Finisher file is a new rotary file presented to be used after root canal instrumentation as a final step in order to improve irrigant penetration and root canal cleaning and disinfection. It is made from a special nickel-titanium (NiTi) MaxWire alloy Hence, it possesses the shape memory effect when inserted into the canal (M-phase changed to A-phase) and exhibits superelasticity during canal preparation.
EC is an irrigation activating device, using an acrylonitrile butadiene styrene plastic instrument designed to produce vigorous intracanal fluid agitation.It has advantages of promoting agitation along the whole length of the instrument with no risk of deforming the canal walls.
There are many methods to evaluate penetration of irrigant solution into root canal but most them laboratory or ex-vivo using dye marker as Rhodamine B stain and methylene blue, while other radiopaque marker as Iohexol are used clinically.
Radiopaque contrast media as Iohexol can be used to assess the effect of various irrigation activating techniques on irrigant penetration into root canals in vivo as they can be seen in dental radiographs. Iohexol has the advantage of being a low osmolality agent that it is readily available in a sterile, pyrogen-free, nontoxic solution. It is widely used for angiocardiographic studies, thoracic and lumbar myelography, and in contrast enhancement for brain computed tomography and imaging of salivary glands.
Activation of irrigantion was considered one important method of bacterial reduction beside decreasing biofilm formation in root canals. on the other hand, it was reported that the activation protocols facilitate the disinfection of anatomical complexities and dentinal tubules.
According to the current knowledge, there is few studies concerning the effect of different irrigation activation techniques on enhancing irrigant penetration into the apical third of root canals and on reducing microbial infection, so this study aims to evaluate irrigant penetration depth and microbial reduction after using different irrigation activation techniques.
- Conditions
- Irrigation Activation, Endodontic Disease
- Being tested
- Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal., Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute, Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.
- Keywords
- Different Irrigation Activating Techniques, primary Endodontic Infection cases
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal.Other
The first microbial sample (S1) will be taken from the root canal immediately after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by matching gutta percha master cone , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software.
Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintuteOther
The first microbial sample (S1) will be taken from the root canal immediately after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by XP-endo Finisher used in continuous rotation for 1 minute , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software.
Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.Other
after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by EasyClean system activation , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software.
| Study group | Role | What they receive |
|---|---|---|
| • Group 1: Manual dynamic agitation by matching gutta-percha master cones | Active comparator | matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal. Receives: Other: Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal. |
| Group 3: Easy Clean system activation | Active comparator | EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation. Receives: Other: Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation. |
| Group 2: XP-endo Finisher activation | Active comparator | XP-endo Finisher used in continuous rotation for 1 minute accompanied with in-and-out movements of approximately 7-mm amplitude will be applied to the instrument according to the manufacturer's recommendations⁸ Receives: Other: Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurment of penetration depth of irrigant
measurment the difference between the working length and penetration depth of irrigant
Measured: at the same 1 day visit
measurment of bacterial reduction following different irrigation activating techniques
collection of 3 samples followed by culturing on blood agar and counting to calculate percentage of bacterial reduction
Measured: 24-28 hours after culturing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Jun 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irrigation ActivationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Samy Abd Elsabour Alfky, Tanta University
- Investigators
- Ali Mahmoud Farag, Phd, Principal investigator, Professor of EndodonticsDalia Abd Elhameed Sherif, Phd, Study director, Lecturer of EndodonticsKareman Ahmed Ebrahim Eshra, Phd, Principal investigator, Professor of clinical Microbiology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660797
- Sponsor's protocol ID
- Irrigation Activation
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreani Y, Gad BT, Cocks TC, Harrison J, Keresztes ME, Pomfret JK, Rees EB, Ma D, Baloun BL, Rahimi M. Comparison of irrigant activation devices and conventional needle irrigation on smear layer and debris removal in curved canals. (Smear layer removal from irrigant activation using SEM). Aust Endod J. 2021 Aug;47(2):143-149. doi: 10.1111/aej.12482. Epub 2021 Mar 8.
PubMed 33682268de Souza DS, S Silva AS, Ormiga F, Lopes RT, Gusman H. The effectiveness of passive ultrasonic irrigation and the easy-clean instrument for removing remnants of filling material. J Conserv Dent. 2021 Jan-Feb;24(1):57-62. doi: 10.4103/JCD.JCD_590_20. Epub 2021 Jul 5.
PubMed 34475681
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and Microbial Reduction in Root Canals (Clinical Study)
- ClinicalTrials.gov ID
- NCT06660797
- Acronym / sponsor ID
- Irrigation Activation
- Conditions
- Irrigation Activation, Endodontic Disease
- Keywords
- Different Irrigation Activating Techniques, primary Endodontic Infection cases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 28 Oct 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 in-vivo study aim to evaluate effect of different irrigation activating techniques on Irrigant Penetration Depth and Microbial Reduction in root Canals
Detailed description
Chemomechanical preparation with removal of infected tissues and microbial biofilms is the corner stone of root canal treatment. Since mechanical instrumentation alone cannot adequately disinfect root canals, complete cleaning and shaping involves irrigation with chemicals together with mechanical instrumentation.
In addition to shaping the root canal, the aim of chemical-mechanical preparation of root canals is to eliminate vital or necrotic tissue, microorganisms and their products, and dentin debris that result from instrumentation. However, the complexity of root canal anatomy together with microbial infection hinder this purpose.
Primary endodontic infection is characterized by the presence of a wide range of microbial diversity dominated by anaerobes. The polymicrobial profile of pulp infection involves both Gram-positive and Gram-negative bacterial species.
Besides, the apical third of the root canal system typically has a complex morphology and is difficult to clean. So, it is important to bring irrigants into contact with the entire canal surfaces along its total micro anatomic complexity for effective action especially in the apical portions .
Irrigating solutions used during endodontic handling act through direct contact with the targeted bacteria. However, irrigants have inadequate penetration depth. It is highly desirable that chemical substances selected as endodontic irrigants have antimicrobial and organic tissue dissolution properties besides serving in the debridement of the root canal system and not being toxic to the tissues .Sodium hypochlorite (NaOCl) has been the gold standard for irrigation because of its ability to dissolve organic matter and high antimicrobial potential.
Conventional needle irrigation is the most commonly employed technique for delivering irrigants into the root canal system. However, the disadvantage of conventional needle irrigation is its passive action, and inability to deliver solutions into the narrow anatomical features of the root canal system. Despite the high success rates of root canal treatment, reducing the bacterial load below the level that is required to assure healing has become the accepted goal. Hence, several irrigant activation systems have been developed to increase the effectiveness of irrigation by providing energy within the canal to disperse and move the irrigant around the canal system in anticipation of them removing biofilm more effectively.
Therefore, various activation and agitation systems have been introduced to improve the irrigation penetration and effectiveness. These systems include manual dynamic agitation, sonic, passive ultrasonic, photon initiated photoacoustic streaming (PIPS), laser, XP-endo Finisher file, and Easy-Clean (EC).
The XP-endo Finisher file is a new rotary file presented to be used after root canal instrumentation as a final step in order to improve irrigant penetration and root canal cleaning and disinfection. It is made from a special nickel-titanium (NiTi) MaxWire alloy Hence, it possesses the shape memory effect when inserted into the canal (M-phase changed to A-phase) and exhibits superelasticity during canal preparation.
EC is an irrigation activating device, using an acrylonitrile butadiene styrene plastic instrument designed to produce vigorous intracanal fluid agitation.It has advantages of promoting agitation along the whole length of the instrument with no risk of deforming the canal walls.
There are many methods to evaluate penetration of irrigant solution into root canal but most them laboratory or ex-vivo using dye marker as Rhodamine B stain and methylene blue, while other radiopaque marker as Iohexol are used clinically.
Radiopaque contrast media as Iohexol can be used to assess the effect of various irrigation activating techniques on irrigant penetration into root canals in vivo as they can be seen in dental radiographs. Iohexol has the advantage of being a low osmolality agent that it is readily available in a sterile, pyrogen-free, nontoxic solution. It is widely used for angiocardiographic studies, thoracic and lumbar myelography, and in contrast enhancement for brain computed tomography and imaging of salivary glands.
Activation of irrigantion was considered one important method of bacterial reduction beside decreasing biofilm formation in root canals. on the other hand, it was reported that the activation protocols facilitate the disinfection of anatomical complexities and dentinal tubules.
According to the current knowledge, there is few studies concerning the effect of different irrigation activation techniques on enhancing irrigant penetration into the apical third of root canals and on reducing microbial infection, so this study aims to evaluate irrigant penetration depth and microbial reduction after using different irrigation activation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| • Group 1: Manual dynamic agitation by matching gutta-percha master cones | Active comparator | Other: Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal.matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal. |
| Group 3: Easy Clean system activation | Active comparator | Other: Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation. |
| Group 2: XP-endo Finisher activation | Active comparator | Other: Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintuteXP-endo Finisher used in continuous rotation for 1 minute accompanied with in-and-out movements of approximately 7-mm amplitude will be applied to the instrument according to the manufacturer's recommendations⁸ |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Asymptomatic vital/non vital teeth requiring root canal treatment.
Key exclusion criteria (6 listed)
- • Patients with any systemic diseases.
- Retreatment cases. Teeth with calcified canals.
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 |
|---|---|---|
| Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal.The first microbial sample (S1) will be taken from the root canal immediately after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by matching gutta percha master cone , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software. | Other | • Group 1: Manual dynamic agitation by matching gutta-percha master cones |
| Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintuteThe first microbial sample (S1) will be taken from the root canal immediately after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by XP-endo Finisher used in continuous rotation for 1 minute , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software. | Other | Group 2: XP-endo Finisher activation |
| Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation.after access cavity preparation and before chemomechanical preparation.Samples will be subjected to bacterial viable count using blood agar. After complete chemomechanical preparation, a second microbial samble (S2) will be taken and managed the same way as S1.After irrigation activation protocol by EasyClean system activation , S3 will be collected from each root canal and managed as S1, S2 to evaluate effect of activation techniques on microbial reduction ,canals will be dried with a matching paper point then 1 mL of Iohexol (omnipaque) contrast media will be injected 2mL shorter than WL and activated by a matching gutta percha master cone , a digital radiographic image will be obtained for each tooth with the same angulation as that for WL and then the distance between WL and maximum irrigant penetration will be measured and recorded using SIDEXIS-XG software. | Other | Group 3: Easy Clean system activation |
Primary outcome
measurment of penetration depth of irrigant
Time frame: at the same 1 day visit
measurment the difference between the working length and penetration depth of irrigant
measurment of bacterial reduction following different irrigation activating techniques
Time frame: 24-28 hours after culturing
collection of 3 samples followed by culturing on blood agar and counting to calculate percentage of bacterial reduction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Background: PubMed 33682268Andreani Y, Gad BT, Cocks TC, Harrison J, Keresztes ME, Pomfret JK, Rees EB, Ma D, Baloun BL, Rahimi M. Comparison of irrigant activation devices and conventional needle irrigation on smear layer and debris removal in curved canals. (Smear layer removal from irrigant activation using SEM). Aust Endod J. 2021 Aug;47(2):143-149. doi: 10.1111/aej.12482. Epub 2021 Mar 8.
- Background: PubMed 34475681de Souza DS, S Silva AS, Ormiga F, Lopes RT, Gusman H. The effectiveness of passive ultrasonic irrigation and the easy-clean instrument for removing remnants of filling material. J Conserv Dent. 2021 Jan-Feb;24(1):57-62. doi: 10.4103/JCD.JCD_590_20. Epub 2021 Jul 5.
- Individual participant dataSharing planned: No
Related trials for Irrigation Activation
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Effects of Irrigation Activation Methods on Periapical Healing in Chronic Apical Periodontitis
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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.
Ali Mahmoud Farag, Phd principal investigator
Professor of Endodontics
Dalia Abd Elhameed Sherif, Phd study director
Lecturer of Endodontics
Kareman Ahmed Ebrahim Eshra, Phd principal investigator
Professor of clinical Microbiology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group1: A matching gutta-percha master cones will be used in up and down motion 2mm amplitude at a frequency of 100 strokes during approximately 1 min in each prepared canal., Group2: XP-endo Finisher activation: The XP-endo Finisher instrument will be used in continuous rotation for 1 mintute and Group 3:EasyClean system activation : EC instrument coupled to the countrangle handpiece and operated with a micromotor at approximately 20,000 rotations per minute in continuous rotation. in people with Irrigation Activation and Endodontic Disease, run by Tanta University at 1 site in Egypt.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alaa Samy, bachelor (+201020630414, alaasamy17395@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurment of penetration depth of irrigant (time frame: at the same 1 day visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06660797, which also lists 2 linked publications.
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 28 Oct 2024.