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

NCT01599091 | Completed

• 2 other identifiers: GF-PDLF-0148-12-HMO-CTIL0148-12-HMO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Disease

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Cytokines, inflammatory mediators and extracellular matrix proteins production and secretion in vitro by fibroblasts

  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 Outcomes (7)

• RNA production in vitro

  outcome will be assessed in vitro within 15 years from specimen collection (basic research)

• cells motion in vitro

  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

  outcome will be assessed in vitro within 15 years from specimen collection (basic research)

• RNA production in vitro by leukocyte cell lines

  outcome will be assessed in vitro within 15 years from specimen collection (basic research)

• Bacterial survival

  outcome will be assessed in vitro within 15 years from specimen collection (basic research)

Study Arms (1)

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

Interventions

Specimens collection OTHER

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.

Fibroblast's donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

: Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (1)

• Somerman MJ, Archer SY, Imm GR, Foster RA. A comparative study of human periodontal ligament cells and gingival fibroblasts in vitro. J Dent Res. 1988 Jan;67(1):66-70. doi: 10.1177/00220345880670011301.

  PMID: 11039048 BACKGROUND

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.

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 15, 2012
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 14, 2020

Record last verified: 2013-09

Locations

IL (1)