Necrotic PulpNCT06418386
Bacterial Reduction of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
A study testing manual saline IA, manual neem IB and manual sodium hypochlorite IC in people with Necrotic Pulp, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- manual saline IA, manual neem IB and manual sodium hypochlorite IC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2022to 12 May 2024
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age group 4 -8 years.
- good health.
- No recent history of antibiotic coverage for at least two weeks
- necrotic teeth.
- restorable tooth structure.
Who cannot join
- more than 2/3 resorption of root.
- uncooperative patient.
- detection perforation on radiograph.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
This study will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction.
Read the detailed description
The calculated sample size of the study will be 22 participants for each group at 5% level of significance and 80 % power 30 participants for each group (10 for The sample size will be increased tocompensate for incomplete data and to increase the study each subgroup) topower
Grouping:
30 child will be selected from the Pediatric Clinic, Faculty of Dentistry, Mansoura University .the child should have 2 contralateral primary molars indicated for pulpectomy. The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file.
Then the children will be randomly sub grouped according to irrigant that will be used:
Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl . clinical procedures :
- Psychological management of child
- X-ray for inclusion criteria
- The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
- . All carious tissue will be removed by sterilized round bur and root canal access will be done
- On gaining the access, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
- In-group 1 will be prepared with manual files the irrigation with saline in IA, with neem in IB and irrigation with NaOCl in IC.
- In group II will be prepared with rotary files the irrigation with saline in IIA, with neem in IIB, with NaOCl in IIC
- The sterile paper point will be introduced into root cannel and will be left for 1 min, the paper point will be removed with sterilized tweezer and then transferred to a tube containing transport medium 19.
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory.
- Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
Laboratory procedures :
- All samples will be incubated on blood agar aerobically and anaerobically at 37 for 48-72 hours and aspectically streak the plates 19,20.
- Identification of bacteria by culture characteristics ,microscopic examination and biochemical reaction 21.
- Number of colony forming unit will be counted (CFU/ml)
- Conditions
- Necrotic Pulp
- Being tested
- manual saline IA, manual neem IB, manual sodium hypochlorite IC, rotary saline IIA, rotary neem IIB
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual saline IAProcedure or surgery
- The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution, All carious tissue will be removed by hight speed handpiece, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min ,The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium),using manual k file starting with #15 and irrigation with normal saline
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
manual neem IBProcedure or surgery
- The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
- . All carious tissue will be removed by high speed hand piece , distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
- using manual file and irrigation with neem leaf extract 100%
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
manual sodium hypochlorite ICProcedure or surgery
- adjacent rubber dam will be disinfected with tincture of iodine solution
- . All carious tissue will be removed by hight speed hand piece
- distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
- using manual file and irrigation with 1% sodium hypochlorite
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
rotary saline IIAProcedure or surgery
- shaping and cleaning done with using AF baby fanta files open file:#17 taper 08,then #20 taper 04 ,yellow then #25 taper 04 red , then #30 taper 04 blue . the files activated with torque 2 and speed 350 . Irrigation with normal saline
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then restored with glass inomar and stainless steel crown
rotary neem IIBProcedure or surgery
- The procedural tooth is anesthetized and isolated with rubber dam as mentioned
- All carious tissue will be removed by high speed hand piece ,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
- using AF baby fanta files SAME AS METION BEFORE ,and irrigation with 100%neem extract
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
rotary sodoium hypochlorite IICProcedure or surgery
- The procedural tooth is anesthetized and isolated with rubber dam as mentioned
- All carious tissue will be removed by hight speed hand piece,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
- using AF baby fanta files SAME AS MENTION BEFORE , and irrigation with 1% sodium hypochlorite
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| manual saline | Active comparator | manual k files for pulpectomy and normal saline irrigation Receives: Procedure: manual saline IA |
| manual neem extract | Experimental | manual k files and 100% neem extract Receives: Procedure: manual neem IB |
| manual sodium hypochlorite | Experimental | mannul k files and 1% sodium hypochlorite Receives: Procedure: manual sodium hypochlorite IC |
| rotary saline | Experimental | AF baby files for pediatric( fanta ) and normal saline Receives: Procedure: rotary saline IIA |
| rotary neem | Experimental | AF baby files for pediatric( fanta ) and 100% NEEM EXTRACT Receives: Procedure: rotary neem IIB |
| rotary sodium hypochloride | Experimental | AF baby files for pediatric( fanta ) and 1% sodium hypochloride Receives: Procedure: rotary sodoium hypochlorite IIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of of colony forming units
number of of colony forming units less the better instrumentation technique and irritant
Measured: 48 hours after culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start12 Sep 2022
- Primary completion15 Dec 2023
- Study completion12 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies 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
- The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file. Then the children will be randomly sub grouped according to irrigant that will be used: Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Mahgoub, Mansoura University
- Investigators
- mansoura university, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418386
- Sponsor's protocol ID
- M18060722
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Susila AV, Sai S, Sharma N, Balasubramaniam A, Veronica AK, Nivedhitha S. Can natural irrigants replace sodium hypochlorite? A systematic review. Clin Oral Investig. 2023 May;27(5):1831-1849. doi: 10.1007/s00784-023-04913-7. Epub 2023 Feb 18.
PubMed 36808559Sundaram D, Narayanan RK, Vadakkepurayil K. A Comparative Evaluation on Antimicrobial Effect of Honey, Neem Leaf Extract and Sodium Hypochlorite as Intracanal Irrigant: An Ex-Vivo Study. J Clin Diagn Res. 2016 Aug;10(8):ZC88-91. doi: 10.7860/JCDR/2016/19268.8311. Epub 2016 Aug 1.
PubMed 27656571Lakshmanan L, Jeevanandan G. Microbial Evaluation of Root Canals after Biomechanical Preparation with Manual K-files, Manual H-files, and Kedo-SG Blue Rotary Files: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):687-690. doi: 10.5005/jp-journals-10005-2457.
PubMed 36866149
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars
- ClinicalTrials.gov ID
- NCT06418386
- Acronym / sponsor ID
- M18060722
- Conditions
- Necrotic Pulp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 12 May 2024 (actual)
- First posted
- 17 May 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 will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction.
Detailed description
The calculated sample size of the study will be 22 participants for each group at 5% level of significance and 80 % power 30 participants for each group (10 for The sample size will be increased tocompensate for incomplete data and to increase the study each subgroup) topower
Grouping:
30 child will be selected from the Pediatric Clinic, Faculty of Dentistry, Mansoura University .the child should have 2 contralateral primary molars indicated for pulpectomy. The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file.
Then the children will be randomly sub grouped according to irrigant that will be used:
Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl . clinical procedures :
- Psychological management of child
- X-ray for inclusion criteria
- The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
- . All carious tissue will be removed by sterilized round bur and root canal access will be done
- On gaining the access, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
- A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
- In-group 1 will be prepared with manual files the irrigation with saline in IA, with neem in IB and irrigation with NaOCl in IC.
- In group II will be prepared with rotary files the irrigation with saline in IIA, with neem in IIB, with NaOCl in IIC
- The sterile paper point will be introduced into root cannel and will be left for 1 min, the paper point will be removed with sterilized tweezer and then transferred to a tube containing transport medium 19.
- Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory.
- Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown
Laboratory procedures :
- All samples will be incubated on blood agar aerobically and anaerobically at 37 for 48-72 hours and aspectically streak the plates 19,20.
- Identification of bacteria by culture characteristics ,microscopic examination and biochemical reaction 21.
- Number of colony forming unit will be counted (CFU/ml)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file. Then the children will be randomly sub grouped according to irrigant that will be used: Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl
| Arm | Type | Receives |
|---|---|---|
| manual saline | Active comparator | Procedure: manual saline IAmanual k files for pulpectomy and normal saline irrigation |
| manual neem extract | Experimental | Procedure: manual neem IBmanual k files and 100% neem extract |
| manual sodium hypochlorite | Experimental | Procedure: manual sodium hypochlorite ICmannul k files and 1% sodium hypochlorite |
| rotary saline | Experimental | Procedure: rotary saline IIAAF baby files for pediatric( fanta ) and normal saline |
| rotary neem | Experimental | Procedure: rotary neem IIBAF baby files for pediatric( fanta ) and 100% NEEM EXTRACT |
| rotary sodium hypochloride | Experimental | Procedure: rotary sodoium hypochlorite IICAF baby files for pediatric( fanta ) and 1% sodium hypochloride |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age group 4 -8 years.
- good health.
- No recent history of antibiotic coverage for at least two weeks
- necrotic teeth.
- restorable tooth structure.
Key exclusion criteria (3 listed)
- more than 2/3 resorption of root.
- uncooperative patient.
- detection perforation on radiograph.
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 |
|---|---|---|
| manual saline IA* The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution, All carious tissue will be removed by hight speed handpiece, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min ,The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium),using manual k file starting with #15 and irrigation with normal saline * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown | Procedure or surgery | manual saline |
| manual neem IB* The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution * . All carious tissue will be removed by high speed hand piece , distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using manual file and irrigation with neem leaf extract 100% * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown | Procedure or surgery | manual neem extract |
| manual sodium hypochlorite IC* adjacent rubber dam will be disinfected with tincture of iodine solution * . All carious tissue will be removed by hight speed hand piece * distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using manual file and irrigation with 1% sodium hypochlorite * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown | Procedure or surgery | manual sodium hypochlorite |
| rotary saline IIA* shaping and cleaning done with using AF baby fanta files open file:#17 taper 08,then #20 taper 04 ,yellow then #25 taper 04 red , then #30 taper 04 blue . the files activated with torque 2 and speed 350 . Irrigation with normal saline * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then restored with glass inomar and stainless steel crown | Procedure or surgery | rotary saline |
| rotary neem IIB* The procedural tooth is anesthetized and isolated with rubber dam as mentioned * All carious tissue will be removed by high speed hand piece ,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using AF baby fanta files SAME AS METION BEFORE ,and irrigation with 100%neem extract * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown | Procedure or surgery | rotary neem |
| rotary sodoium hypochlorite IIC* The procedural tooth is anesthetized and isolated with rubber dam as mentioned * All carious tissue will be removed by hight speed hand piece,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure. * A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium). * using AF baby fanta files SAME AS MENTION BEFORE , and irrigation with 1% sodium hypochlorite * Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown | Procedure or surgery | rotary sodium hypochloride |
Primary outcome
number of of colony forming units
Time frame: 48 hours after culture
number of of colony forming units less the better instrumentation technique and irritant
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 May 2024.
- Background: PubMed 36808559Susila AV, Sai S, Sharma N, Balasubramaniam A, Veronica AK, Nivedhitha S. Can natural irrigants replace sodium hypochlorite? A systematic review. Clin Oral Investig. 2023 May;27(5):1831-1849. doi: 10.1007/s00784-023-04913-7. Epub 2023 Feb 18.
- Background: PubMed 27656571Sundaram D, Narayanan RK, Vadakkepurayil K. A Comparative Evaluation on Antimicrobial Effect of Honey, Neem Leaf Extract and Sodium Hypochlorite as Intracanal Irrigant: An Ex-Vivo Study. J Clin Diagn Res. 2016 Aug;10(8):ZC88-91. doi: 10.7860/JCDR/2016/19268.8311. Epub 2016 Aug 1.
- Background: PubMed 36866149Lakshmanan L, Jeevanandan G. Microbial Evaluation of Root Canals after Biomechanical Preparation with Manual K-files, Manual H-files, and Kedo-SG Blue Rotary Files: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):687-690. doi: 10.5005/jp-journals-10005-2457.
- Individual participant dataSharing planned: No
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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.
mansoura university study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual saline IA, manual neem IB and manual sodium hypochlorite IC in people with Necrotic Pulp, run by Mansoura 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 3 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 May 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?
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?
number of of colony forming units (time frame: 48 hours after culture). 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 NCT06418386, which also lists 3 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 29 May 2024.