Trial record 18 of 104 for:    Open Studies | "Periodontal Diseases"

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

This study is currently recruiting participants.
Verified September 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01599091
First received: May 3, 2012
Last updated: September 8, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Periodontal Disease
Other: Specimens collection

Study Type: Observational
Official Title: Characterizing Gingival and Periodontal Ligament Fibroblasts Reaction to Infection With the Perio- Pathogenic Bacteria Porphyromonas Gingivalis

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • RNA production in vitro [ Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research) ] [ Designated as safety issue: No ]
    RNA production following in vitro stimulation of fibroblasts with Porphyromonas gingivalis will be examined to assess their function during periodontal disease.

  • cells motion in vitro [ Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research) ] [ Designated as safety issue: No ]
    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

  • 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) ] [ Designated as safety issue: No ]
    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

  • RNA production in vitro by leukocyte cell lines [ Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research) ] [ Designated as safety issue: No ]
    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

  • Bacterial survival [ Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research) ] [ Designated as safety issue: No ]
    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.

  • Bacterial adherence to fibroblasts and leukocytes in vitro [ Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research) ] [ Designated as safety issue: No ]
    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.

  • cell apoptosis (rate and speed) [ Time Frame: outcome will be assessed in vitro within 15 years from specimen collection (basic research) ] [ Designated as safety issue: No ]
    in vitro cell apoptosis (rate and speed) will be examined following stimulation with Porphyromonas gingivalis


Biospecimen Retention:   Samples With DNA

Anyway extracted teeth and gingiva. 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.


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599091

Contacts
Contact: Asaf Wilensky, DMD, PhD +972 2 6777826 asafw@ekmd.huji.ac.il
Contact: Rinat Tzach, DMD +972 2 6777826 Rinat.tzach@gmail.com

Locations
Israel
: Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01599091     History of Changes
Other Study ID Numbers: GF-PDLF-0148-12-HMO-CTIL, 0148-12-HMO
Study First Received: May 3, 2012
Last Updated: September 8, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Fibroblasts
Periodontal ligament
Gingiva
Porphyromonas gingivalis
Chronic periodontitis
( patients undergoing tooth extraction will be asked permission to use extracted tooth and gingiva for periodontal disease basic research)

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 17, 2014