NCT04713436

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 11, 2021

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 year

Study Arms (3)

Triple antibiotic paste(TAP)

ciprofloxacin, metronidazole and minocycline

Drug: Differentiation Markers

Doble antibiotic paste(DAP)

ciprofloxacin and metronidazole

Drug: Differentiation Markers

Modified triple antibiotic paste(mTAP)

ciprofloxacin, metronidazole and cefaclor

Drug: Differentiation Markers

Interventions

Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.

Also known as: Gene expression levels
Doble antibiotic paste(DAP)Modified triple antibiotic paste(mTAP)Triple antibiotic paste(TAP)

Eligibility Criteria

Age16 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Tissue samples were obtained from the apex of the extracted third molar teeth of young adult patients aged between 16-22 .

You may qualify if:

  • Patients with open apex third molar teeth for extraction indication

You may not qualify if:

  • Patients with mature apex third molar teeth for extraction indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue samples were obtained from the apex of the extracted third molar teeth of young adult patients aged between 16-22 (N=7).

MeSH Terms

Interventions

Antigens, Differentiation

Intervention Hierarchy (Ancestors)

Antigens, SurfaceAntigensBiological FactorsBiomarkers

Study Officials

  • Seçil Çalışkan

    Eskişehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 19, 2021

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

February 1, 2017

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations