Necrosis, PulpNCT03690960
Antimicrobial Effect of Modified Antibiotic Nanofibers for Regenerative Endodontics Procedures
A study testing electrospun TAP nanofibers and modified TAP paste in people with Necrosis, Pulp, run by Cairo University.
Trial summary
The treatment for immature teeth with pulp necrosis can be carried out through apexification or regenerative endodontics procedures including platelet rich plasma (PRP), platelet rich fibrin (PRF) and injectable PRF, these techniques used alone or in combination. Read more about this study
- Who is it for?
- Ages 7 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrosis, Pulp
- What is being tested?
- electrospun TAP nanofibers and modified TAP paste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Oct 2020
- 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 7 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Maxillary or mandibular single-root tooth with:
- Non-vital response of pulp tissue.
- Immature root.
- Asymptomatic patients.
Who cannot join
- Patients allergic to metronidazole, ciprofloxacin, or clindamycin to avoid allergic reaction in the intervention group.
- Patients who received antibiotics in the past 3 months.
- Vital cases or previously accessed teeth.
- Teeth with unfavorable conditions for rubber-dam application.
- Patients with systemic and immune-compromising disease as they have impaired healing
About this study
Official title: Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics A Randomized Clinical Trial
The treatment for immature teeth with pulp necrosis can be carried out through apexification or regenerative endodontics procedures including platelet rich plasma (PRP), platelet rich fibrin (PRF) and injectable PRF, these techniques used alone or in combination. Revascularization therapy carries on more advantages than apexification, such as inducing root-end development and reinforcement. However, apical repair will not happen in the presence of inflamed and infected tissue.the aim of this study is to evaluate the antimicrobial effect of pre-synthesized novel antibiotic loaded electrospun nanofibers used in patients with immature necrotic teeth.
Read the detailed description
Title: Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics - A Randomized Clinical Trial
Rationale Regenerative endodontics technique outcome depends on microbial elimination because apical repair will not happen in the presence of infected tissues. It is well established that bacteria are essential for the development of pulpal and periapical pathosis. Eradication or control of bacteria may provide optimal treatment outcome. However, elimination of bacteria from infected root canal systems is challenging. Numerous measures have been described to reduce the number of bacteria in the root canal system, including the use of various instrumentation techniques, irrigation regimens and intra-canal medicaments. There is no definitive evidence in the literature that all these measures result in a bacteria-free root canal system.
Therefore additional methods such as the use of intra-canal medicaments are required in order to maximize disinfection of root canal system and kill as many bacteria as possible. Antibiotics have been proposed as intracanal medicament but any single antibiotic is unlikely effective to sterilize diverse flora in root canal infection.
Recently, triple antibiotic mixture (TAP) has been reported for successful disinfection of infected root dentine. This mixture consist of ciprofloxacin (CIP), metronidazole (MET) and minocycline (MINO) which consistently sterilize bacteria of infected dentine and infected pulps . Specifically, MET is a bactericidal imidazole that is highly effective against obligate anaerobic bacteria, CIP is a bactericidal broad-spectrum synthetic quinolone and MINO is a bacteriostatic broad-spectrum tetracycline.
However, as minocycline binds to dentin and causes tooth discoloration, it is recommended to remove minocycline from TAP and use only MET and CIP, or to use modified TAPs containing cefaclor or clindamycin (CLIN). CLIN is a bacteriostatic lincosamide known for its efficacy against a broad spectrum of endodontic bacteria.
In recent years, an innovative strategy has been considered to develop a low-concentration, yet antimicrobially effective and biocompatible polymer-based nanofibrous electrospun scaffolds as a drug delivery system to promote intracanal biofilm eradication . Electrospinning has been considered as a highly effective process to obtain extracellular matrix (ECM) mimicking structures with adequate chemistry and three-dimensional porous architectures Moreover, it has enabled the synthesis of bioactive nanofibrous scaffolds The electrospinning technology has attracted great interest in recent decades, thanks to its capability of easily and effectively processing a huge range of polymeric materials in form of nanofibers. In recent years, the health concerns associated with the systemic side effects of synthetic compounds used in medicine and the emergence of antibiotic resistance of pathogens have driven electrospinning research towards the development of antibiotic loaded nanofibers.
Hypothesis To test the null hypothesis, which is in patients with necrotic immature teeth, will the use of pre-synthesized clindamycin modified triple antibiotic electrospun nanofibers have more profound antimicrobial effect than modified triple antibiotic paste.
Objectives of the present study
- Primary objective To compare the antimicrobial effect of pre-synthesized novel antibiotic loaded nanofibers used in patients with immature necrotic teeth with modified triple antibiotic paste.
- Secondary objective To evaluate the morphology of pre-synthesized antibiotic loaded electrospun nanofibers.
- Conditions
- Necrosis, Pulp
- Being tested
- electrospun TAP nanofibers, modified TAP paste
- Keywords
- immature teeth
- 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.
electrospun TAP nanofibersProcedure or surgery
electrospun TAP loaded nanofibers containing modified triple antibiotic paste of clindamycin , ciprofloxacin and metronidazole by electrospinning process will be placed in the root canals. The access cavity will be sealed with temporary filling material
modified TAP pasteProcedure or surgery
modified TAP paste will be prepared by mixing equal proportions of CIP, MET and CLIN then placed inside the root canal, access cavity will be sealed with temporary filling
| Study group | Role | What they receive |
|---|---|---|
| electrospun TAP nanofibers | Experimental | Revascularization procedure with Electrospun TAP nanofibers as as an intracanal medicament for immature necrotic teeth Receives: Procedure: electrospun TAP nanofibers |
| modified TAP paste | Active comparator | Revascularization procedure with modified TAP paste as an intracanal medicament for immature necrotic teeth Receives: Procedure: modified TAP paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
antimicrobial effect
number of colony forming units of bacteria after using the intracanal medicaments
Measured: 2-3 weeks
Secondary outcomes (1)
morphology of nanofibers
surface morphology will be studied under the scanning electron microscope
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study startDec 2018 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrosis, PulpStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara Gamal Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690960
- Sponsor's protocol ID
- Cairo University dentistry
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03690960
- Acronym / sponsor ID
- Cairo University dentistry
- Conditions
- Necrosis, Pulp
- Keywords
- immature teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 1 Oct 2018 (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 treatment for immature teeth with pulp necrosis can be carried out through apexification or regenerative endodontics procedures including platelet rich plasma (PRP), platelet rich fibrin (PRF) and injectable PRF, these techniques used alone or in combination. Revascularization therapy carries on more advantages than apexification, such as inducing root-end development and reinforcement. However, apical repair will not happen in the presence of inflamed and infected tissue.the aim of this study is to evaluate the antimicrobial effect of pre-synthesized novel antibiotic loaded electrospun nanofibers used in patients with immature necrotic teeth.
Detailed description
Title: Evaluation of the Antimicrobial Effect of Pre-synthesized Novel Antibiotic Electrospun Nanofibers as an Intracanal Delivery Strategy for Regenerative Endodontics - A Randomized Clinical Trial
Rationale Regenerative endodontics technique outcome depends on microbial elimination because apical repair will not happen in the presence of infected tissues. It is well established that bacteria are essential for the development of pulpal and periapical pathosis. Eradication or control of bacteria may provide optimal treatment outcome. However, elimination of bacteria from infected root canal systems is challenging. Numerous measures have been described to reduce the number of bacteria in the root canal system, including the use of various instrumentation techniques, irrigation regimens and intra-canal medicaments. There is no definitive evidence in the literature that all these measures result in a bacteria-free root canal system.
Therefore additional methods such as the use of intra-canal medicaments are required in order to maximize disinfection of root canal system and kill as many bacteria as possible. Antibiotics have been proposed as intracanal medicament but any single antibiotic is unlikely effective to sterilize diverse flora in root canal infection.
Recently, triple antibiotic mixture (TAP) has been reported for successful disinfection of infected root dentine. This mixture consist of ciprofloxacin (CIP), metronidazole (MET) and minocycline (MINO) which consistently sterilize bacteria of infected dentine and infected pulps . Specifically, MET is a bactericidal imidazole that is highly effective against obligate anaerobic bacteria, CIP is a bactericidal broad-spectrum synthetic quinolone and MINO is a bacteriostatic broad-spectrum tetracycline.
However, as minocycline binds to dentin and causes tooth discoloration, it is recommended to remove minocycline from TAP and use only MET and CIP, or to use modified TAPs containing cefaclor or clindamycin (CLIN). CLIN is a bacteriostatic lincosamide known for its efficacy against a broad spectrum of endodontic bacteria.
In recent years, an innovative strategy has been considered to develop a low-concentration, yet antimicrobially effective and biocompatible polymer-based nanofibrous electrospun scaffolds as a drug delivery system to promote intracanal biofilm eradication . Electrospinning has been considered as a highly effective process to obtain extracellular matrix (ECM) mimicking structures with adequate chemistry and three-dimensional porous architectures Moreover, it has enabled the synthesis of bioactive nanofibrous scaffolds The electrospinning technology has attracted great interest in recent decades, thanks to its capability of easily and effectively processing a huge range of polymeric materials in form of nanofibers. In recent years, the health concerns associated with the systemic side effects of synthetic compounds used in medicine and the emergence of antibiotic resistance of pathogens have driven electrospinning research towards the development of antibiotic loaded nanofibers.
Hypothesis To test the null hypothesis, which is in patients with necrotic immature teeth, will the use of pre-synthesized clindamycin modified triple antibiotic electrospun nanofibers have more profound antimicrobial effect than modified triple antibiotic paste.
Objectives of the present study
- Primary objective To compare the antimicrobial effect of pre-synthesized novel antibiotic loaded nanofibers used in patients with immature necrotic teeth with modified triple antibiotic paste.
- Secondary objective To evaluate the morphology of pre-synthesized antibiotic loaded electrospun nanofibers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrospun TAP nanofibers | Experimental | Procedure: electrospun TAP nanofibersRevascularization procedure with Electrospun TAP nanofibers as as an intracanal medicament for immature necrotic teeth |
| modified TAP paste | Active comparator | Procedure: modified TAP pasteRevascularization procedure with modified TAP paste as an intracanal medicament for immature necrotic teeth |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Non-vital response of pulp tissue.
- Immature root.
- Asymptomatic patients.
Key exclusion criteria (5 listed)
- Patients allergic to metronidazole, ciprofloxacin, or clindamycin to avoid allergic reaction in the intervention group.
- Patients who received antibiotics in the past 3 months.
- Vital cases or previously accessed teeth.
- Teeth with unfavorable conditions for rubber-dam application.
- Patients with systemic and immune-compromising disease as they have impaired healing
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 |
|---|---|---|
| electrospun TAP nanofiberselectrospun TAP loaded nanofibers containing modified triple antibiotic paste of clindamycin , ciprofloxacin and metronidazole by electrospinning process will be placed in the root canals. The access cavity will be sealed with temporary filling material | Procedure or surgery | electrospun TAP nanofibers |
| modified TAP pastemodified TAP paste will be prepared by mixing equal proportions of CIP, MET and CLIN then placed inside the root canal, access cavity will be sealed with temporary filling | Procedure or surgery | modified TAP paste |
Primary outcome
antimicrobial effect
Time frame: 2-3 weeks
number of colony forming units of bacteria after using the intracanal medicaments
1 secondary outcome
morphology of nanofibers
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing electrospun TAP nanofibers and modified TAP paste in people with Necrosis, Pulp, run by Cairo University.
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 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
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?
antimicrobial effect (time frame: 2-3 weeks). 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 1 Oct 2018.