Periodontal DiseaseNCT00982813
Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes
A study testing Periodontal screening in people with Periodontal Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- Periodontal screening
- Type of treatment
- Pill or oral medicine
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Sep 2010
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women older than 18
- Pre-term birth between 24 and 37 gestational weeks
Who cannot join
- Patient's opposition
- Delivery before 24 gestational weeks or after 37 gestational weeks
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.
- Conditions
- Periodontal Disease
- Being tested
- Periodontal screening
- Keywords
- Periodontal disease, Per-term delivery, Sulcular bleeding index, Bacteriological gingival presence, Cytokines, Active periodontal disease with sulcular bleeding index, Bacteriological sampling in periodontal pocketing, Cytokines in the periodontal pocketing
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal screeningOther
Periodontal screening in all patients giving birth between 24 and 37 gestational weeks.
Bacteriological sampling in the periodontal pocketing. Search for specific cytokines in the periodontal pocketing. Professional prophylaxis and oral hygiene instruction.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sulcular bleeding index as active disease
Measured: one week after delivery
Secondary outcomes (5)
Plaque index
Measured: one week after delivery
Depth of periodontal pocketing
Measured: one week after delivery
Clinical attachment level
Measured: one week after delivery
Bacterial sampling of gingival crevicular fluid
Measured: One week after delivery
Search for cytokines in the gingival crevicular fluid
Measured: one week after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionSep 2010
Why it stopped: Difficulties of internal organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri-Jean PHILIPPE, Prof., Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982813
- Sponsor's protocol ID
- BRD 09/4-G
- Status last verified
- Oct 2013
- First submitted
- 22 Sep 2009
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Influence of Periodontal Diseases on Pre-term Birth: Observation in the Maternity Hospital of Nantes
- ClinicalTrials.gov ID
- NCT00982813
- Acronym / sponsor ID
- BRD 09/4-G
- Conditions
- Periodontal Disease
- Keywords
- Periodontal disease, Per-term delivery, Sulcular bleeding index, Bacteriological gingival presence, Cytokines, Active periodontal disease with sulcular bleeding index, Bacteriological sampling in periodontal pocketing, Cytokines in the periodontal pocketing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of internal organization
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 23 Sep 2009 (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.
The aim of the study is to determine the influence of the periodontal diseases in patients giving pre-term birth in the maternity hospital of Nantes. A French population is observed. The clinical, bacteriological and microbiological aspects will confirmed a comparative study which aim is dental prevention in the beginning of the pregnancy to avoid premature delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women older than 18
- Pre-term birth between 24 and 37 gestational weeks
Key exclusion criteria (2 listed)
- Patient's opposition
- Delivery before 24 gestational weeks or after 37 gestational weeks
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 |
|---|---|---|
| Periodontal screeningPeriodontal screening in all patients giving birth between 24 and 37 gestational weeks. Bacteriological sampling in the periodontal pocketing. Search for specific cytokines in the periodontal pocketing. Professional prophylaxis and oral hygiene instruction. | Other | – |
Primary outcome
Sulcular bleeding index as active disease
Time frame: one week after delivery
5 secondary outcomes
Plaque index
Time frame: one week after delivery
Depth of periodontal pocketing
Time frame: one week after delivery
Clinical attachment level
Time frame: one week after delivery
Bacterial sampling of gingival crevicular fluid
Time frame: One week after delivery
Search for cytokines in the gingival crevicular fluid
Time frame: one week after delivery
Results and safety
The study was stopped early (reason given: Difficulties of internal organization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
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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.
Henri-Jean PHILIPPE, Prof. principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal screening in people with Periodontal Disease, run by Nantes University Hospital 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 7 Oct 2013. 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?
The study was stopped early (reason given: Difficulties of internal organization). Results are not available in the source record.
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?
Sulcular bleeding index as active disease (time frame: one week after delivery). 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 7 Oct 2013.