Pulp NecrosesPhase 2NCT04533074
Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry
A Phase 2 study testing Single-visit regeneration protocol and Multiple-visits regeneration protocol in people with Pulp Necroses and Tooth, Nonvital, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pulp Necroses, Tooth, Nonvital
- What is being tested?
- Single-visit regeneration protocol and Multiple-visits regeneration protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Aug 2018to 15 Mar 2021
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Immature permanent upper anterior teeth.
- Necrotic teeth confirmed by sensibility test.
- Teeth with periapical lesions confirmed by periapical radiograph using paralleling device.
Who cannot join
- Teeth with orthodontic wires or brackets.
- Patient with history of allergy to any medication.
- Patient with history of bleeding disorders.
- Patient with medical illness or taking medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)
Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols.
Read the detailed description
Thirty patients with necrotic immature permanent teeth showing periapical lesions will be randomly divided in two groups: group (1) single visit regeneration and group (2) multiple visits regeneration protocol, in which calcium hydroxide will be applied for one week or more according to resolution of signs and symptoms. Dentin debris collected on a file will be taken as microbiologic sample to be cultured and examined by MALDI-TOF MS. This will be performed after the access cavity preparation and after irrigation in both groups, these samples will be labelled A and B, respectively. In group (2) there will be a third sample labeled C which will be taken after the removal of the intra canal calcium hydroxide.
- Conditions
- Pulp Necroses, Tooth, Nonvital
- Being tested
- Single-visit regeneration protocol, Multiple-visits regeneration protocol
- Medical subject headings
- Dental Pulp Necrosis, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-visit regeneration protocolBiological
In a single visit, access opening, minimal instrumentation and irrigation will be done. After irrigation and drying, the apical tissue will be irritated to evoke bleeding in the canal, using a precurved K-file 2mm past the apical foramen, with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. The bleeding will be stopped at a level that allows for 3-4 mm of restorative material. Three millimeters of Biodentine will then be placed directly over the blood clot of each tooth. A 3-4 mm layer of glass ionomer is flowed gently over the capping material. Each access cavity will be restored using composite resin.
Multiple-visits regeneration protocolBiological
In the first visit, access opening, minimal instrumentation and irrigation will be done. The root canal will be then dried and filled with calcium hydroxide paste. The tooth will be sealed with an intermediate restorative material (IRM), and the patient will be dismissed for 1-4weeks. In the second appointment, response to initial treatment will be assessed and the steps will be repeated if symptoms are persistent. If there are no symptoms, evoking bleeding to the level of the cemento-enamel junction will be done followed by Biodentine application over the blood clot with final glass ionomer and composite restorations.
| Study group | Role | What they receive |
|---|---|---|
| Single-visit regeneration protocol | Experimental | Not described Receives: Biological: Single-visit regeneration protocol |
| Multiple-visits regeneration protocol | Active comparator | Not described Receives: Biological: Multiple-visits regeneration protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological assessment
The presence or absence of reduction in types of micro-organisms in root canals
Measured: 24 hours
Tooth vitality
Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no).
Measured: up to 12 months
Tooth mobility
- Mobility will be recorded according to Grace \& Smales Mobility Index
- Grade 0: No apparent mobility
- Grade 1: Perceptible mobility <1mm in buccolingual direction
- Grade 2: 1mm< but <2mm
- Grade 3: 2mm< or depressibility in the socket
Measured: up to 12 months
Healing of periapical lesions
Periapical index score (PAI) will be used for identification of apical periodontitis on both periapical radiography and Cone-beam computed tomographic (CBCT).
It is a 6-point (0 -5) scoring system with 2 additional variables, expansion of cortical bone and destruction of cortical bone.The PAI will be determined by the largest extension of the lesion on periapical radiography and CBCT scans in 3 dimensions: axial, sagittal, and coronal.
- Score 0 Intact periapical bone structures.
- Score 1 Diameter of periapical radiolucency "0.5-1 mm.
- Score 2 Diameter of periapical radiolucency "1-2 mm.
- Score 3 Diameter of periapical radiolucency "2-4 mm.
- Score 4 Diameter of periapical radiolucency "4-8 mm.
- Score 5 Diameter of periapical radiolucency "8 mm.
- Score (n)# E: Expansion of periapical cortical bone.
- Score (n)# D: Destruction of periapical cortical bone.
Measured: up to 12 months
Root lengthening
The root length will be measured as a straight line from the CEJ to the radiographic apex of the tooth. This will be measured on both periapical radiography and Cone-beam computed tomographic (CBCT) in millimeters.
Measured: up to 12 months
Root thickening
The dentinal wall thickness for both the preoperative and recall images will be measured at the level of the apical one third of the preoperative root canal length measured from the CEJ. The root canal width and the pulp space will be measured at this level, and the remaining dentin thickness will be calculated by subtracting the pulp space from the root canal width.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start23 Aug 2018
- Primary completion10 Mar 2021
- Study completion15 Mar 2021
Why it stopped: due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pulp NecrosesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Pervine H. Sharaf, M.Sc, Principal investigator, Faculty of Dentistry, Alexandria University, EgyptRaef A Sherif, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptAshraf M Zaazou, PhD, Study chair, Faculty of Dentistry, Alexandria University, EgyptRania M ElBackly, PhD, Study director, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533074
- Sponsor's protocol ID
- MALDI-TOF MS regeneration
- Status last verified
- Mar 2022
- First submitted
- 27 Aug 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia-Godoy F, Murray PE. Recommendations for using regenerative endodontic procedures in permanent immature traumatized teeth. Dent Traumatol. 2012 Feb;28(1):33-41. doi: 10.1111/j.1600-9657.2011.01044.x. Epub 2011 Jul 27.
PubMed 21794081El Ashiry EA, Farsi NM, Abuzeid ST, El Ashiry MM, Bahammam HA. Dental Pulp Revascularization of Necrotic Permanent Teeth with Immature Apices. J Clin Pediatr Dent. 2016;40(5):361-6. doi: 10.17796/1053-4628-40.5.361.
PubMed 27617376Diogenes A, Ruparel NB, Shiloah Y, Hargreaves KM. Regenerative endodontics: A way forward. J Am Dent Assoc. 2016 May;147(5):372-80. doi: 10.1016/j.adaj.2016.01.009. Epub 2016 Mar 24.
PubMed 27017182Flanagan TA. What can cause the pulps of immature, permanent teeth with open apices to become necrotic and what treatment options are available for these teeth. Aust Endod J. 2014 Dec;40(3):95-100. doi: 10.1111/aej.12087.
PubMed 25470507Aggarwal V, Miglani S, Singla M. Conventional apexification and revascularization induced maturogenesis of two non-vital, immature teeth in same patient: 24 months follow up of a case. J Conserv Dent. 2012 Jan;15(1):68-72. doi: 10.4103/0972-0707.92610.
PubMed 22368339Altaii M, Richards L, Rossi-Fedele G. Histological assessment of regenerative endodontic treatment in animal studies with different scaffolds: A systematic review. Dent Traumatol. 2017 Aug;33(4):235-244. doi: 10.1111/edt.12338. Epub 2017 Apr 20.
PubMed 28342218Saoud TMA, Ricucci D, Lin LM, Gaengler P. Regeneration and Repair in Endodontics-A Special Issue of the Regenerative Endodontics-A New Era in Clinical Endodontics. Dent J (Basel). 2016 Feb 27;4(1):3. doi: 10.3390/dj4010003.
PubMed 29563445McTigue DJ, Subramanian K, Kumar A. Case series: management of immature permanent teeth with pulpal necrosis: a case series. Pediatr Dent. 2013 Jan-Feb;35(1):55-60.
PubMed 23635900Khoshkhounejad M, Shokouhinejad N, Pirmoazen S. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes. J Dent (Tehran). 2015 Jun;12(6):460-8.
PubMed 26884781Chaniotis A. The use of a single-step regenerative approach for the treatment of a replanted mandibular central incisor with severe resorption. Int Endod J. 2016 Aug;49(8):802-12. doi: 10.1111/iej.12515. Epub 2015 Aug 21.
PubMed 26197881Nagata JY, Rocha-Lima TF, Gomes BP, Ferraz CC, Zaia AA, Souza-Filho FJ, De Jesus-Soares A. Pulp revascularization for immature replanted teeth: a case report. Aust Dent J. 2015 Sep;60(3):416-20. doi: 10.1111/adj.12342. Epub 2015 Jul 29.
PubMed 26219350Saoud TM, Huang GT, Gibbs JL, Sigurdsson A, Lin LM. Management of Teeth with Persistent Apical Periodontitis after Root Canal Treatment Using Regenerative Endodontic Therapy. J Endod. 2015 Oct;41(10):1743-8. doi: 10.1016/j.joen.2015.07.004. Epub 2015 Aug 14.
PubMed 26279479Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16.
PubMed 18571000Chueh LH, Ho YC, Kuo TC, Lai WH, Chen YH, Chiang CP. Regenerative endodontic treatment for necrotic immature permanent teeth. J Endod. 2009 Feb;35(2):160-4. doi: 10.1016/j.joen.2008.10.019. Epub 2008 Dec 12.
PubMed 19166764Tagelsir A, Yassen GH, Gomez GF, Gregory RL. Effect of Antimicrobials Used in Regenerative Endodontic Procedures on 3-week-old Enterococcus faecalis Biofilm. J Endod. 2016 Feb;42(2):258-62. doi: 10.1016/j.joen.2015.09.023. Epub 2015 Nov 11.
PubMed 26577870
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Evaluation of Single Versus Multiple Visits Regeneration Using MALDI-TOF Mass Spectrometry (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04533074
- Acronym / sponsor ID
- MALDI-TOF MS regeneration
- Conditions
- Pulp Necroses, Tooth, Nonvital
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to the COVID-19 pandemic
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 31 Aug 2020 (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.
Aim of the study is to assess canal disinfection using matrix assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) in single visit and multiple visit regeneration protocols, and to assess clinical and radiographic outcomes of single visit and multiple visit regeneration protocols.
Detailed description
Thirty patients with necrotic immature permanent teeth showing periapical lesions will be randomly divided in two groups: group (1) single visit regeneration and group (2) multiple visits regeneration protocol, in which calcium hydroxide will be applied for one week or more according to resolution of signs and symptoms. Dentin debris collected on a file will be taken as microbiologic sample to be cultured and examined by MALDI-TOF MS. This will be performed after the access cavity preparation and after irrigation in both groups, these samples will be labelled A and B, respectively. In group (2) there will be a third sample labeled C which will be taken after the removal of the intra canal calcium hydroxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-visit regeneration protocol | Experimental | Biological: Single-visit regeneration protocol |
| Multiple-visits regeneration protocol | Active comparator | Biological: Multiple-visits regeneration protocol |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Immature permanent upper anterior teeth.
- Necrotic teeth confirmed by sensibility test.
- Teeth with periapical lesions confirmed by periapical radiograph using paralleling device.
Key exclusion criteria (4 listed)
- Teeth with orthodontic wires or brackets.
- Patient with history of allergy to any medication.
- Patient with history of bleeding disorders.
- Patient with medical illness or taking medications.
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 |
|---|---|---|
| Single-visit regeneration protocolIn a single visit, access opening, minimal instrumentation and irrigation will be done. After irrigation and drying, the apical tissue will be irritated to evoke bleeding in the canal, using a precurved K-file 2mm past the apical foramen, with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. The bleeding will be stopped at a level that allows for 3-4 mm of restorative material. Three millimeters of Biodentine will then be placed directly over the blood clot of each tooth. A 3-4 mm layer of glass ionomer is flowed gently over the capping material. Each access cavity will be restored using composite resin. | Biological | Single-visit regeneration protocol |
| Multiple-visits regeneration protocolIn the first visit, access opening, minimal instrumentation and irrigation will be done. The root canal will be then dried and filled with calcium hydroxide paste. The tooth will be sealed with an intermediate restorative material (IRM), and the patient will be dismissed for 1-4weeks. In the second appointment, response to initial treatment will be assessed and the steps will be repeated if symptoms are persistent. If there are no symptoms, evoking bleeding to the level of the cemento-enamel junction will be done followed by Biodentine application over the blood clot with final glass ionomer and composite restorations. | Biological | Multiple-visits regeneration protocol |
Primary outcome
Microbiological assessment
Time frame: 24 hours
The presence or absence of reduction in types of micro-organisms in root canals
Tooth vitality
Time frame: up to 12 months
Tooth vitality will be assessed by sensibility testing using thermal stimulation, binary (yes or no).
Tooth mobility
Time frame: up to 12 months
4. Mobility will be recorded according to Grace \& Smales Mobility Index * Grade 0: No apparent mobility * Grade 1: Perceptible mobility <1mm in buccolingual direction * Grade 2: 1mm< but <2mm * Grade 3: 2mm< or depressibility in the socket
Healing of periapical lesions
Time frame: up to 12 months
Periapical index score (PAI) will be used for identification of apical periodontitis on both periapical radiography and Cone-beam computed tomographic (CBCT). It is a 6-point (0 -5) scoring system with 2 additional variables, expansion of cortical bone and destruction of cortical bone.The PAI will be determined by the largest extension of the lesion on periapical radiography and CBCT scans in 3 dimensions: axial, sagittal, and coronal. * Score 0 Intact periapical bone structures. * Score 1 Diameter of periapical radiolucency "0.5-1 mm. * Score 2 Diameter of periapical radiolucency "1-2 mm. * Score 3 Diameter of periapical radiolucency "2-4 mm. * Score 4 Diameter of periapical radiolucency "4-8 mm. * Score 5 Diameter of periapical radiolucency "8 mm. * Score (n)# E: Expansion of periapical cortical bone. * Score (n)# D: Destruction of periapical cortical bone.
Root lengthening
Time frame: up to 12 months
The root length will be measured as a straight line from the CEJ to the radiographic apex of the tooth. This will be measured on both periapical radiography and Cone-beam computed tomographic (CBCT) in millimeters.
Root thickening
Time frame: up to 12 months
The dentinal wall thickness for both the preoperative and recall images will be measured at the level of the apical one third of the preoperative root canal length measured from the CEJ. The root canal width and the pulp space will be measured at this level, and the remaining dentin thickness will be calculated by subtracting the pulp space from the root canal width.
Results and safety
The study was stopped early (reason given: due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 21794081Garcia-Godoy F, Murray PE. Recommendations for using regenerative endodontic procedures in permanent immature traumatized teeth. Dent Traumatol. 2012 Feb;28(1):33-41. doi: 10.1111/j.1600-9657.2011.01044.x. Epub 2011 Jul 27.
- Background: PubMed 27617376El Ashiry EA, Farsi NM, Abuzeid ST, El Ashiry MM, Bahammam HA. Dental Pulp Revascularization of Necrotic Permanent Teeth with Immature Apices. J Clin Pediatr Dent. 2016;40(5):361-6. doi: 10.17796/1053-4628-40.5.361.
- Background: PubMed 27017182Diogenes A, Ruparel NB, Shiloah Y, Hargreaves KM. Regenerative endodontics: A way forward. J Am Dent Assoc. 2016 May;147(5):372-80. doi: 10.1016/j.adaj.2016.01.009. Epub 2016 Mar 24.
- Background: PubMed 25470507Flanagan TA. What can cause the pulps of immature, permanent teeth with open apices to become necrotic and what treatment options are available for these teeth. Aust Endod J. 2014 Dec;40(3):95-100. doi: 10.1111/aej.12087.
- Background: PubMed 22368339Aggarwal V, Miglani S, Singla M. Conventional apexification and revascularization induced maturogenesis of two non-vital, immature teeth in same patient: 24 months follow up of a case. J Conserv Dent. 2012 Jan;15(1):68-72. doi: 10.4103/0972-0707.92610.
- Background: PubMed 28342218Altaii M, Richards L, Rossi-Fedele G. Histological assessment of regenerative endodontic treatment in animal studies with different scaffolds: A systematic review. Dent Traumatol. 2017 Aug;33(4):235-244. doi: 10.1111/edt.12338. Epub 2017 Apr 20.
- Background: PubMed 29563445Saoud TMA, Ricucci D, Lin LM, Gaengler P. Regeneration and Repair in Endodontics-A Special Issue of the Regenerative Endodontics-A New Era in Clinical Endodontics. Dent J (Basel). 2016 Feb 27;4(1):3. doi: 10.3390/dj4010003.
- Background: PubMed 23635900McTigue DJ, Subramanian K, Kumar A. Case series: management of immature permanent teeth with pulpal necrosis: a case series. Pediatr Dent. 2013 Jan-Feb;35(1):55-60.
- Background: PubMed 26884781Khoshkhounejad M, Shokouhinejad N, Pirmoazen S. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes. J Dent (Tehran). 2015 Jun;12(6):460-8.
- Background: PubMed 26197881Chaniotis A. The use of a single-step regenerative approach for the treatment of a replanted mandibular central incisor with severe resorption. Int Endod J. 2016 Aug;49(8):802-12. doi: 10.1111/iej.12515. Epub 2015 Aug 21.
- Background: PubMed 26219350Nagata JY, Rocha-Lima TF, Gomes BP, Ferraz CC, Zaia AA, Souza-Filho FJ, De Jesus-Soares A. Pulp revascularization for immature replanted teeth: a case report. Aust Dent J. 2015 Sep;60(3):416-20. doi: 10.1111/adj.12342. Epub 2015 Jul 29.
- Background: PubMed 26279479Saoud TM, Huang GT, Gibbs JL, Sigurdsson A, Lin LM. Management of Teeth with Persistent Apical Periodontitis after Root Canal Treatment Using Regenerative Endodontic Therapy. J Endod. 2015 Oct;41(10):1743-8. doi: 10.1016/j.joen.2015.07.004. Epub 2015 Aug 14.
Related trials for Pulp Necroses
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Active, not recruiting
Effect of Apical Patency on Periapical Lesion Healing
Periapical Lesion, Apical Periodontitis
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
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.
Pervine H. Sharaf, M.Sc principal investigator
Faculty of Dentistry, Alexandria University, Egypt
Raef A Sherif, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
Ashraf M Zaazou, PhD study chair
Faculty of Dentistry, Alexandria University, Egypt
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 Single-visit regeneration protocol and Multiple-visits regeneration protocol in people with Pulp Necroses and Tooth, Nonvital, run by Nourhan M.Aly 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Mar 2022. 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 was stopped early (reason given: due to the COVID-19 pandemic). Results are not available in the source record.
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?
Microbiological assessment (time frame: 24 hours). The study lists 6 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 NCT04533074, which also lists 18 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 Mar 2022.