Periodontal DiseaseNCT01599091
Characterizing Gingival and Periodontal Ligament Fibroblasts Reaction to Infection With the Bacteria Porphyromonas Gingivalis
An observational study of Periodontal Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Specimens collection
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healty over 18 years of age eligible for signing patients that go through tooth extraction for reasons not related to the study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients treated with antibiotics in the 2 months preceding the tooth extraction.
- Smoking patients.
- Patients with alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Periodontal Disease
- Being tested
- Specimens collection
- 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)
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimens collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Specimens collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: primary outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Secondary outcomes (7)
RNA production in vitro
RNA production following in vitro stimulation of fibroblasts with Porphyromonas gingivalis will be examined to assess their function during periodontal disease.
Measured: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
cells motion in vitro
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
Measured: 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
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
Measured: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
RNA production in vitro by leukocyte cell lines
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
Measured: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Bacterial survival
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.
Measured: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Bacterial adherence to fibroblasts and leukocytes in vitro
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.
Measured: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
cell apoptosis (rate and speed)
in vitro cell apoptosis (rate and speed) will be examined following stimulation with Porphyromonas gingivalis
Measured: outcome will be assessed in vitro within 15 years from specimen collection (basic research)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599091
- Sponsor's protocol ID
- GF-PDLF-0148-12-HMO-CTIL
- Other IDs
- 0148-12-HMO
- Status last verified
- Sep 2013
- First submitted
- 3 May 2012
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11039048
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Gingival and Periodontal Ligament Fibroblasts Reaction to Infection With the Perio- Pathogenic Bacteria Porphyromonas Gingivalis
- ClinicalTrials.gov ID
- NCT01599091
- Acronym / sponsor ID
- GF-PDLF-0148-12-HMO-CTIL
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 May 2012 (estimated)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroblast's donors | – | Other: Specimens collectionPatients undergoing tooth extraction will be asked permission to use the anyway extracted teeth and gingiva in order to harvest fibroblasts for further basic research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healty over 18 years of age eligible for signing patients that go through tooth extraction for reasons not related to the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Specimens collectionTooth 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. | Other | Fibroblast's donors |
Primary outcome
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.
7 secondary outcomes
RNA production in vitro
Time frame: 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)
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)
RNA production in vitro by leukocyte cell lines
Time frame: 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)
Bacterial adherence to fibroblasts and leukocytes in vitro
Time frame: 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)
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 14 Aug 2020.
- Background: PubMed 11039048Somerman 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontal Disease, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 9 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 14 Aug 2020. 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 Israel. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599091, which also lists 1 linked publication.
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 14 Aug 2020.