Periodontitis, AdultParo-Proto 2NCT03178838
Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis
An observational study of Periodontitis, Adult, run by Central Hospital, Nancy, France.
Trial summary
The buccal cavity presents microorganismes whose the number and composition vary with oral hygiene and medical context (pathologies and associated drug therapies) of the patient. More than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the sub-gingival biofilm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Adult
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2013to 11 Nov 2014
- 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: Patients consulting in the periodontal department of CHU, Nancy.
Who may be able to join
- Adults > 18 years-old
- Consulting in periodontal department of CHU, Nancy
- Patient with moderate to severe periodontitis
- At least 2 periodontal sites with PPD≥ 4mm and One healthy site
- No scaling root planning in the last 6 months
- Patients insured under the French social security system
Who cannot join
- Pregnant patients
- Patients with antibiotic therapy, and/or all medecines which could modify the buccal microbiota in the last 6 months
- Tooth with endodontic periapical lesion
- Patients having a scaling root planning in the last 6 months
- Patient with guardianship
About this study
Official title: Preliminary Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis Consulting to CHU of Nancy, in Periodontal Department.
The buccal cavity presents microorganismes whose the number and composition vary with oral hygiene and medical context (pathologies and associated drug therapies) of the patient. More than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens other play unclear role in this pathology. They belong respectively to the red and orange complex of Socransky et al. (1998).
Other microorganismes such as virures, yeasts and protozoans could potentially impact the emergence and development of periodontal diseases. The presence of protozoans in periodontitis have been investigated in this study.
- Conditions
- Periodontitis, Adult
- Medical subject headings
- Chronic Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of protozoans
Measured: baseline
Secondary outcomes (5)
Periodontal pocket depth (mm)
Measured: baseline
Clinical attachment loss (mm)
Measured: baseline
Plaque and gingival index
Measured: baseline
Mobility of the tooth (Yes/No)
Measured: baseline
Presence of bleeding on probing (Yes/No)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start3 Dec 2013
- Primary completion11 Nov 2014
- Study completion11 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine BISSON, PhD, Principal investigator, CHRU Nancy / Université de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178838
- Sponsor's protocol ID
- PSS2016/PARO-PROTO-BISSON/VS
- Acronym
- Paro-Proto 2
- Status last verified
- Nov 2017
- First submitted
- 6 Jun 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Commission Nationale de l'Informatique et des libertés
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Study of the Presence of Trichomonas Tenax and Entamoeba Gingivalis in Patients With Periodontitis Consulting to CHU of Nancy, in Periodontal Department.
- ClinicalTrials.gov ID
- NCT03178838
- Acronym / sponsor ID
- Paro-Proto 2 / PSS2016/PARO-PROTO-BISSON/VS
- Conditions
- Periodontitis, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 11 Nov 2014 (actual)
- Study completion
- 11 Nov 2014 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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.
The buccal cavity presents microorganismes whose the number and composition vary with oral hygiene and medical context (pathologies and associated drug therapies) of the patient. More than 1200 bacterial species have been identified, and among them, 400 are inhabitants of the sub-gingival biofilm. Among all these microorganismes, only 20 species participate to the etiopathogenesis of periodontal diseases.Some are recognised as major periodontopathogens other play unclear role in this pathology. They belong respectively to the red and orange complex of Socransky et al. (1998).
Other microorganismes such as virures, yeasts and protozoans could potentially impact the emergence and development of periodontal diseases. The presence of protozoans in periodontitis have been investigated in this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting in the periodontal department of CHU, Nancy.
Key inclusion criteria (6 listed)
- Adults > 18 years-old
- Consulting in periodontal department of CHU, Nancy
- Patient with moderate to severe periodontitis
- At least 2 periodontal sites with PPD≥ 4mm and One healthy site
- No scaling root planning in the last 6 months
Key exclusion criteria (5 listed)
- Pregnant patients
- Patients with antibiotic therapy, and/or all medecines which could modify the buccal microbiota in the last 6 months
- Tooth with endodontic periapical lesion
- Patients having a scaling root planning in the last 6 months
- Patient with guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of protozoans
Time frame: baseline
5 secondary outcomes
Periodontal pocket depth (mm)
Time frame: baseline
Clinical attachment loss (mm)
Time frame: baseline
Plaque and gingival index
Time frame: baseline
Mobility of the tooth (Yes/No)
Time frame: baseline
Presence of bleeding on probing (Yes/No)
Time frame: baseline
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 Nov 2017.
- Individual participant dataSharing planned: No. Commission Nationale de l'Informatique et des libertés
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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.
Catherine BISSON, PhD principal investigator
CHRU Nancy / Université de Lorraine
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, Adult, run by Central Hospital, Nancy, France.
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 6 inclusion and 5 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Presence of protozoans (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2017.