Stem CellsNCT04713436
The Effects of Antibiotic Combinations on Stem Cells
An observational study of Stem Cells and Anti-Bacterial Agents, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to evaluate the indirect effects of antibiotic combinations. SCAP viability, proliferation and apoptosis of the cells were evaluated. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated. Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cells, Anti-Bacterial Agents
- What is being tested?
- Differentiation Markers
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2014to 1 Feb 2017
- Phase
- Observational
- 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 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Tissue samples were obtained from the apex of the extracted third molar teeth of young adult patients aged between 16-22 .
Who may be able to join
- Patients with open apex third molar teeth for extraction indication
Who cannot join
- Patients with mature apex third molar teeth for extraction indication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, 26040
About this study
Official title: The Effects of Antibiotic Combinations on Mesenchymal Stem Cells Derived From Apical Papilla
The purpose of this study was to evaluate the indirect effects of antibiotic combinations. SCAP viability, proliferation and apoptosis of the cells were evaluated. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
Read the detailed description
The purpose of this study was to evaluate the indirect effects of triple (TAP- ciprofloxacin, metronidazole and minocycline), double (DAP- ciprofloxacin and metronidazole) and modified triple antibiotic pastes (mTAP- ciprofloxacin, metronidazole and cefaclor) on mesenchmal stem cells derived from apical papilla (SCAP). SCAP were isolated from the impacted third molar teeth of the young adults. TAP, DAP and mTAP treatment (14-day medication and 28-day medication) were applied on SCAP and viability, proliferation and apoptosis of the cells were evaluated after four weeks. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
- Conditions
- Stem Cells, Anti-Bacterial Agents
- Being tested
- Differentiation Markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differentiation MarkersDrug
Also called Gene expression levels
Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Triple antibiotic paste(TAP) | ciprofloxacin, metronidazole and minocycline Receives: Drug: Differentiation Markers | |
| Doble antibiotic paste(DAP) | ciprofloxacin and metronidazole Receives: Drug: Differentiation Markers | |
| Modified triple antibiotic paste(mTAP) | ciprofloxacin, metronidazole and cefaclor Receives: Drug: Differentiation Markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurment of Cell Viability and Apoptosis
To evaluate cell viability and apoptosis MuseCell Analyzer Count and Viability kit (Merck Millipore, Taufkirchen, Germany) was used according to the manufacturer's protocol.
Measured: 1 year
Measurment of cell differantiation
To determine gene expression levels, total RNA of SCAP was extracted using the Ambion PureLink RNA mini kit (Invitrogen, US) and the Roche cell RNA Kit (Penzberg, Germany) according to the manufacturer's instructions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Jan 2014
- Primary completion1 Jan 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem CellsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Seçil Çalışkan, Eskisehir Osmangazi University
- Investigators
- Seçil Çalışkan, Principal investigator, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713436
- Sponsor's protocol ID
- 2015-68
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antibiotic Combinations on Mesenchymal Stem Cells Derived From Apical Papilla
- ClinicalTrials.gov ID
- NCT04713436
- Acronym / sponsor ID
- 2015-68
- Conditions
- Stem Cells, Anti-Bacterial Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 19 Jan 2021 (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 purpose of this study was to evaluate the indirect effects of antibiotic combinations. SCAP viability, proliferation and apoptosis of the cells were evaluated. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
Detailed description
The purpose of this study was to evaluate the indirect effects of triple (TAP- ciprofloxacin, metronidazole and minocycline), double (DAP- ciprofloxacin and metronidazole) and modified triple antibiotic pastes (mTAP- ciprofloxacin, metronidazole and cefaclor) on mesenchmal stem cells derived from apical papilla (SCAP). SCAP were isolated from the impacted third molar teeth of the young adults. TAP, DAP and mTAP treatment (14-day medication and 28-day medication) were applied on SCAP and viability, proliferation and apoptosis of the cells were evaluated after four weeks. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple antibiotic paste(TAP) | – | Drug: Differentiation Markersciprofloxacin, metronidazole and minocycline |
| Doble antibiotic paste(DAP) | – | Drug: Differentiation Markersciprofloxacin and metronidazole |
| Modified triple antibiotic paste(mTAP) | – | Drug: Differentiation Markersciprofloxacin, metronidazole and cefaclor |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Tissue samples were obtained from the apex of the extracted third molar teeth of young adult patients aged between 16-22 .
Key inclusion criteria (1 listed)
- Patients with open apex third molar teeth for extraction indication
Key exclusion criteria (1 listed)
- Patients with mature apex third molar teeth for extraction indication
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 |
|---|---|---|
| Differentiation MarkersAlso: Gene expression levelsOsteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated. | Drug | Doble antibiotic paste(DAP), Modified triple antibiotic paste(mTAP), Triple antibiotic paste(TAP) |
Primary outcome
Measurment of Cell Viability and Apoptosis
Time frame: 1 year
To evaluate cell viability and apoptosis MuseCell Analyzer Count and Viability kit (Merck Millipore, Taufkirchen, Germany) was used according to the manufacturer's protocol.
Measurment of cell differantiation
Time frame: 1 year
To determine gene expression levels, total RNA of SCAP was extracted using the Ambion PureLink RNA mini kit (Invitrogen, US) and the Roche cell RNA Kit (Penzberg, Germany) according to the manufacturer's instructions.
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 19 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Seçil Çalışkan principal investigator
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cells and Anti-Bacterial Agents, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 19 Jan 2021. 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 Turkey (Türkiye). 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?
Measurment of Cell Viability and Apoptosis (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2021.