Pulp and Periapical Tissue DiseasePhase 2NCT05964686
The Efficacy of Laser in Root Canal Disinfection
A Phase 2 study testing Conventional group (NaOCl/EDTA), Dual laser group (Er,Cr:YSGG/Diode): and Combined group (EDTA/Diode): in people with Pulp and Periapical Tissue Disease and Pulp Necroses, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp and Periapical Tissue Disease, Pulp Necroses, Pulp; Granuloma
- What is being tested?
- Conventional group (NaOCl/EDTA), Dual laser group (Er,Cr:YSGG/Diode): and Combined group (EDTA/Diode):
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Dec 2022
- Phase
- Phase 2
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients who are medically free.
- Patient's age between 18-35 years.
- One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic apical periodontitis requiring root canal treatment.
- Patients complaining of no pain and without fistulous tract.
- Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al. (1986)108
- Closed apex.
- Acceptance to participate in the study.
Who cannot join
- Patients suffering from any systemic disease.
- Patients who had received antibiotics during the last month.
- Patients taking analgesics 12 hours before interventions.
- Patients with history of tobacco usage
- Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.
- Teeth with previous endodontic treatment.
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- Non restorable teeth where rubber dam could not be applied.
- Teeth with periodontal pocket more than 3 mm.
- Teeth with greater than grade 1 mobility.
- Teeth with swelling/sinus tract.
- Technical difficulties in the course of root canal treatment for example:
- A tooth with curved roots
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.
Thirty patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.
Read the detailed description
The use of lasers in disinfection of the root canal has been recently implemented. Lasers have bactericidal effect, and have deep penetration depth inside the root canal up to 1000 um. Thus, it can be used effectively for disinfection of the root canal system following biomechanical instrumentation reaching areas which were considered before non-reachable.
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.
Thirty patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination After disinfection, local anesthetic and tooth isolation and access cavity preparation, the first microbial samples (S1) will be collected using 3 sterile paper points and immediately placed inside sterile tubes containing transport medium of thioglycolate, cleaning and shaping with final disinfection protocol will be performed according to the group in which the participant was allocated to. Followed by S2 sample. obturation using warm vertical compaction technique. Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.
- Being tested
- Conventional group (NaOCl/EDTA), Dual laser group (Er,Cr:YSGG/Diode):, Combined group (EDTA/Diode):
- Keywords
- LASER, Endodontics, canal disinfection
- Medical subject headings
- Dental Pulp Necrosis, Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional group (NaOCl/EDTA)Combination product
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
Dual laser group (Er,Cr:YSGG/Diode):Combination product
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
Combined group (EDTA/Diode):Combination product
17% EDTA was used to remove smear layer followed by diode laser for disinfection
| Study group | Role | What they receive |
|---|---|---|
| Conventional group A | Active comparator | Not described Receives: Combination Product: Conventional group (NaOCl/EDTA) |
| Dual laser group B | Experimental | Not described Receives: Combination Product: Dual laser group (Er,Cr:YSGG/Diode): |
| Combined group C | Experimental | Not described Receives: Combination Product: Combined group (EDTA/Diode): |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative microbiological analysis
aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
Measured: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jan 2022
- Primary completion30 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp and Periapical Tissue DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Sara Zakaria Fahim, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964686
- Sponsor's protocol ID
- FDASU-Rec ID 041908
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05964686
- Acronym / sponsor ID
- FDASU-Rec ID 041908
- Keywords
- LASER, Endodontics, canal disinfection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 28 Jul 2023 (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.
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.
Thirty patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.
Detailed description
The use of lasers in disinfection of the root canal has been recently implemented. Lasers have bactericidal effect, and have deep penetration depth inside the root canal up to 1000 um. Thus, it can be used effectively for disinfection of the root canal system following biomechanical instrumentation reaching areas which were considered before non-reachable.
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used.
Thirty patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination After disinfection, local anesthetic and tooth isolation and access cavity preparation, the first microbial samples (S1) will be collected using 3 sterile paper points and immediately placed inside sterile tubes containing transport medium of thioglycolate, cleaning and shaping with final disinfection protocol will be performed according to the group in which the participant was allocated to. Followed by S2 sample. obturation using warm vertical compaction technique. Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional group A | Active comparator | Combination Product: Conventional group (NaOCl/EDTA) |
| Dual laser group B | Experimental | Combination Product: Dual laser group (Er,Cr:YSGG/Diode): |
| Combined group C | Experimental | Combination Product: Combined group (EDTA/Diode): |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Patients who are medically free.
Key exclusion criteria (12 listed)
- Patients suffering from any systemic disease.
- Patients who had received antibiotics during the last month.
- Patients taking analgesics 12 hours before interventions.
- Patients with history of tobacco usage
- Teeth with vital pulp, calcified canals, and immature or incompletely formed apices.
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 |
|---|---|---|
| Conventional group (NaOCl/EDTA)conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA | Combination product | Conventional group A |
| Dual laser group (Er,Cr:YSGG/Diode):Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection | Combination product | Dual laser group B |
| Combined group (EDTA/Diode):17% EDTA was used to remove smear layer followed by diode laser for disinfection | Combination product | Combined group C |
Primary outcome
Quantitative microbiological analysis
Time frame: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]
aerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml). anaerobic bacterial count will be assessed using colony forming units (CFU) and will be expressed in (CFU/ml).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional group (NaOCl/EDTA), Dual laser group (Er,Cr:YSGG/Diode): and Combined group (EDTA/Diode): in people with Pulp and Periapical Tissue Disease and Pulp Necroses, run by Future University in Egypt 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 29 Nov 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative microbiological analysis (time frame: baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]). 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 29 Nov 2023.