Periodontitis, AdultParo-ProtoNCT03240666
Protozoans in Biofilm From Patients With Periodontitis
An observational study of Periodontitis, Adult, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- non applicable
- How many people
- 231 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2017to 30 Nov 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients consulting to periodontal department of CHRU (Nancy-Nice- Toulouse) presenting at least two PPD of 5mm and more, without any medecines which could modify microbiota were included in this study
Who may be able to join
- Adults > 18 years-old
- consulting in periodontal department of CHRU
- Patients with moderate to severe periodontitis
- At least 2 periodontal sites with PPD ≥ 5mm and one healthy site
- No scaling root planing in the last 6 months
- Patients insured under the Franch social security system
Who cannot join
- Pregnants patients
- Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months
- Tooth with endodontics periapical lesion
- Patients having a scaling root planing in the last 6 months
- Patients with guardianship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Catherine BISSON
Nancy, 54000
Catherine BISSON, DDS, +33 383852952, catherine.bisson@univ-lorraine.fr
Severine VINCENT-BUGNAS, DDS
About this study
Official title: Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis
The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.
Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .
Others microorganisms such as protozoans could have an impact on this disease.
- Conditions
- Periodontitis, Adult
- Being tested
- non applicable
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non applicableOther
non applicable
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of protozoans
identification of protozoans by molecular technique (PCR) -
Measured: 6 months after the last inclusion: DNA samples were frozen and identified later.
Secondary outcomes (5)
Periodontal pocket depth (PPD in mm)
Measure of PPD thanks to periodontal probe
Measured: One day: measure realised during examination of the patient for periodontal treatment.
Clinical attachment Loss (CAL in mm)
Measure of CAL with periodontal probe
Measured: One day: measure realied during clincal examination of patient.
Plaque and gingival index
Measure of plaque and gingival index (Loe and Silness, Silness and Loe)
Measured: One day: measure of index during the clinical examination of patient.
Mobility of tooth
Measure of tooth mobility: Yes or not
Measured: One day: measure of tooth mobility during the clinical examination of patient.
Bleeding On Probing (BOP)
Measure of BOP : Yes or not
Measured: One day: measure of BOP during the clinical examination of patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start10 Apr 2017
- Primary completion10 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
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
- Cohort
- Time perspective
- Other
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240666
- Sponsor's protocol ID
- PSS2016/PARO-PROTO-BISSON/ER
- Acronym
- Paro-Proto
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2017
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: non applicable
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT03240666
- Acronym / sponsor ID
- Paro-Proto / PSS2016/PARO-PROTO-BISSON/ER
- Conditions
- Periodontitis, Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, University Hospital, Toulouse
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 10 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 7 Aug 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 is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.
Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .
Others microorganisms such as protozoans could have an impact on this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting to periodontal department of CHRU (Nancy-Nice- Toulouse) presenting at least two PPD of 5mm and more, without any medecines which could modify microbiota were included in this study
Key inclusion criteria (6 listed)
- Adults > 18 years-old
- consulting in periodontal department of CHRU
- Patients with moderate to severe periodontitis
- At least 2 periodontal sites with PPD ≥ 5mm and one healthy site
- No scaling root planing in the last 6 months
Key exclusion criteria (5 listed)
- Pregnants patients
- Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months
- Tooth with endodontics periapical lesion
- Patients having a scaling root planing in the last 6 months
- Patients 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non applicablenon applicable | Other | – |
Primary outcome
presence of protozoans
Time frame: 6 months after the last inclusion: DNA samples were frozen and identified later.
identification of protozoans by molecular technique (PCR) -
5 secondary outcomes
Periodontal pocket depth (PPD in mm)
Time frame: One day: measure realised during examination of the patient for periodontal treatment.
Clinical attachment Loss (CAL in mm)
Time frame: One day: measure realied during clincal examination of patient.
Plaque and gingival index
Time frame: One day: measure of index during the clinical examination of patient.
Mobility of tooth
Time frame: One day: measure of tooth mobility during the clinical examination of patient.
Bleeding On Probing (BOP)
Time frame: One day: measure of BOP during the clinical examination of patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: Undecided. non applicable
Related trials for Periodontitis, Adult
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Not yet recruitingObservational study
Evaluation of Changes in Oral Health-related Quality of Life During the Treatment of Periodontitis.
Periodontitis, Adult, Periodontitis
Not yet recruiting
Sonic Irrigation Activation for Postoperative Pain After Root Canal Treatment
Asymptomatic Apical Periodontitis
Active, not recruiting
Utilization of a Videoscope in Periodontal Regeneration
Chronic Periodontitis
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.
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 Periodontitis, Adult, run by Central Hospital, Nancy, France at 1 site in 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El Mehdi SIAGHY (+33 383 15 52 85, m.siaghy@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of protozoans (time frame: 6 months after the last inclusion: DNA samples were frozen and identified later.). 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 21 Apr 2021.