Characterizing Gingival and Periodontal Ligament Fibroblasts Reaction to Infection With the Bacteria Porphyromonas Gingivalis

August 13, 2020 updated by: Hadassah Medical Organization

Characterizing Gingival and Periodontal Ligament Fibroblasts Reaction to Infection With the Perio- Pathogenic Bacteria Porphyromonas Gingivalis

Porphyromonas gingivalis is one of the major bacteria involved in the formation and progression of chronic periodontitis. Pathogens invading the gingiva face the host's innate immune system at first and later on the acquired immune system which includes secreted antibodies and specialized cells. Although both the arms of the immune system are coordinated to overcome the infection, there are several known mechanisms which help pathogens as Porphyromonas gingivalis evade immunity. As a result, inflammatory mediators secreted by immune cells cause tissue damage and lead the inflammation process towards chronicity instead of clearing the pathogen. Up till recently most of the studies focused on the role of macrophages, dendritic cells and lymphocytes at the response to periodontal pathogenic bacteria while the role of fibroblasts (the most abundant cell in the connective tissue) was less examined. Fibroblasts are spindle shaped cells which have the ability to produce extra cellular matrix and respond to growth factors and cytokines. They are able to affect cells in the infected tissue and contribute to immune response efficiency. As known in the case of lymphocytes, fibroblasts also vary in subtypes, each differs in phenotype, immune interactions, extra cellular matrix production and destruction, migration abilities and so on. Two main fibroblasts subtypes in the oral cavity originate in the gingival tissue and the periodontal ligament anchoring teeth to the surrounding alveolar bone. Amongst the differences between the two are collagen production ability and receptors profile over the cell surface. Considering all that, the investigators aim to obtain and use periodontal ligament and gingival tissues removed anyways during common dental procedures in order to extract the different fibroblasts subtypes residing there and compare their response to Porphyromonas gingivalis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • : Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healty over 18 years of age eligible for signing patients that go through tooth extraction for reasons not related to the study.

Description

Inclusion Criteria:

  • Healthy men and women over 18 years of age, eligible for signing
  • Patient in need for a tooth extraction regardless of the study
  • Patient understanding and in consent to the character and the purpose of the study
  • Patient with healthy gingival and connective tissue surrounding the tooth to be extracted

Exclusion Criteria:

  • Pregnant or nursing women. children or non judgemental patients
  • Patient undergoing tooth extraction due to periodontitis or any reason related to a problem in the tooth connective tissue
  • patient with a Rontgenic bone loss around the tooth to be extracted.
  • Patient with any oral disease other than gingivitis.
  • Patients with need of pre-medication prior to invasive procedures.
  • Patients with background disease or regular use of medications
  • Patients treated with antibiotics in the 2 months preceding the tooth extraction.
  • Smoking patients.
  • Patients with alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Fibroblast's donors
Patients undergoing tooth extraction will be asked permission to use the anyway extracted teeth and gingiva in order to harvest fibroblasts for further basic research.
Other: Specimens collection
Tooth extraction will be preformed in the regular way regardless of the study. Patients will be asked permission to obtain the extracted tooth and excess of gingival remnants for further in vitro investigation in the main investigator's laboratory.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cytokines, inflammatory mediators and extracellular matrix proteins production and secretion in vitro by fibroblasts
Time Frame: primary outcome will be assessed in vitro within 15 years from specimen collection (basic research)
healthy patients undergoing tooth extraction will be asked permission to use the anyway extracted tooth and gingiva for basic laboratory research. Periodontal ligament and gingival fibroblasts will be harvested from the collected specimens. Protein production and secretion following in vitro stimulation of the fibroblasts with Porphyromonas gingivalis will be examined to assess their function during periodontal disease.
primary outcome will be assessed in vitro within 15 years from specimen collection (basic research)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
RNA production in vitro
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
RNA production following in vitro stimulation of fibroblasts with Porphyromonas gingivalis will be examined to assess their function during periodontal disease.
outcome will be assessed in vitro within 15 years from specimen collection (basic research)
cells motion in vitro
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
fibroblasts and leukocytes (cell line) motion in vitro following co-culture and stimulation with Porphyromonas gingivalis will be examined to assess their function and interactions during periodontal disease
outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Cytokines, inflammatory mediators and extracellular matrix proteins production and secretion by leukocyte cell lines in vitro
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
fibroblasts and leukocytes (cell line) will be co-cultured with and without Porphyromonas gingivalis stimulation in vitro. Protein production and secretion by leukocytes will be examined to assess their function and interactions with fibroblasts during periodontal disease
outcome will be assessed in vitro within 15 years from specimen collection (basic research)
RNA production in vitro by leukocyte cell lines
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
fibroblasts and leukocytes (cell line) will be co-cultured with and without Porphyromonas gingivalis stimulation in vitro. RNA production by leukocytes will be examined to assess their function and interactions with fibroblasts during periodontal disease
outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Bacterial survival
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Porphyromonas gingivalis survival in vitro following incubation with fibroblasts and leukocytes cell lines (in mono or co-cultures ) will be examined to elucidate cells-bacterial interactions leading to periodontal disease chronicity.
outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Bacterial adherence to fibroblasts and leukocytes in vitro
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Porphyromonas gingivalis in vitro adherance to fibroblasts and leukocytes cell lines (in mono or co-cultures ) will be examined to elucidate cells-bacterial interactions leading to periodontal disease chronicity.
outcome will be assessed in vitro within 15 years from specimen collection (basic research)
cell apoptosis (rate and speed)
Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
in vitro cell apoptosis (rate and speed) will be examined following stimulation with Porphyromonas gingivalis
outcome will be assessed in vitro within 15 years from specimen collection (basic research)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GF-PDLF-0148-12-HMO-CTIL
  • 0148-12-HMO (Other Identifier: Hadassah Medical Organization)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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