Periodontal RecessionsRecessionNCT04175314
Severity of Periodontal Recession and Associated Risk Factors in France.
An observational study of Periodontal Recessions, run by Central Hospital, Nancy, France at 5 sites in France.
Trial summary
The severity of periodontal recessions for each examined patient during dental consultation was evaluated. Moreover, the description of the number of periodontal recessions in patients with good health during dental consultation, the associated risk factors and evaluation of the number of recessions which need… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Recessions
- What is being tested?
- Clinical examination of gingival tissues
- How many people
- 240 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Jan 2017to 5 Feb 2021
- How long will I take part?
- 1 Day
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients are selected during a dental consultation.
Who may be able to join
- Case:
- patients aged from 20 to 50 years
- patients with recession of more than 1mm
- patient with good health
- patients who aggreed to participate to the study
- Controls:
Show all 10Show fewer
- patients aged from 20 to 50 years
- patients with no recession or recession less than 1mm
- patient with good health
- patients who aggreed to participate to the study
Who cannot join
- patients with periodontitis
- patients with recession of Class III and IV of modified Miller classification
- patients with previous muco-gingival surgery
- patients pregnant, breatheeding
- patients refusing to participate to the study
Trial locations and contacts
5 sites in 1 country.
Catherine BISSON contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Henri Mondor
Créteil, 94010
Sophie-Myriam DRIDI, PhD, dr.sm.dridi@free.fr
- Not yet recruiting
CHU
Montpellier, 34295
Valérie ORTI, PhD, valerie.orti30@gmail.com
- Recruiting
CHU
Nancy, 54000
Catherine BISSON, PhD, catherine.bisson@univ-lorraine.fr
- Not yet recruiting
CHU Saint Roch
Nice, 06000
Sophie-Myriam DRIDI, PhD, dr.sm.dridi@free.fr
- Not yet recruiting
CHU Ragueil
Toulouse, 31062
Pierre BARTHET, PhD, barthet_pierre@orange.fr
About this study
Official title: Severity of Periodontal Recession by Patient and Associated Risk Factors in France.
The severity of periodontal recessions for each examined patient during dental consultation was evaluated. Moreover, the description of the number of periodontal recessions in patients with good health during dental consultation, the associated risk factors and evaluation of the number of recessions which need surgical therapy were realized.
- Conditions
- Periodontal Recessions
- Being tested
- Clinical examination of gingival tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination of gingival tissuesOther
Measure of the periodontal recession
| Study group | Role | What they receive |
|---|---|---|
| Case - | Patient presenting one or more periodontal recession more than 1mm of height Receives: Other: Clinical examination of gingival tissues | |
| Control- | Patient presenting no periodontal recession or recession of less than 1 mm of height Receives: Other: Clinical examination of gingival tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of periodontal recession severity
Measure of the height and the width of periodontal recession (millimeter)
Measured: Observation at day 1
Secondary outcomes (4)
Number of recessions for each patient
Evaluation of the number of recessions for each patient
Measured: Observation at day 1
Associated risk factors
Evaluation of smoking status, general health, periodontum and dental parameters, evaluation of toothbrush and dental treatment
Measured: Observation at day 1
Number of participants with recession-related adverse events as assessed by questionnaire
Evaluation of the needs of surgical treatment of the periodontal recessions observed according to pain evaluated by questionnaire
Measured: Observation at day 1
Frequency of periodontal recession according to the modified Miller classifcation
Measure of the periodontal recession according to the modified Miller classification
Measured: Observation at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start10 Jan 2017
- Primary completion6 Feb 2017
- Study completion5 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal RecessionsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine BISSON, Principal investigator, Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175314
- Sponsor's protocol ID
- PSS2016/RECESSION-BISSON/MS
- Acronym
- Recession
- Status last verified
- Jul 2019
- First submitted
- 20 Aug 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severity of Periodontal Recession by Patient and Associated Risk Factors in France.
- ClinicalTrials.gov ID
- NCT04175314
- Acronym / sponsor ID
- Recession / PSS2016/RECESSION-BISSON/MS
- Conditions
- Periodontal Recessions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 5 Feb 2021 (estimated)
- First posted
- 25 Nov 2019 (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 severity of periodontal recessions for each examined patient during dental consultation was evaluated. Moreover, the description of the number of periodontal recessions in patients with good health during dental consultation, the associated risk factors and evaluation of the number of recessions which need surgical therapy were realized.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case - | – | Other: Clinical examination of gingival tissuesPatient presenting one or more periodontal recession more than 1mm of height |
| Control- | – | Other: Clinical examination of gingival tissuesPatient presenting no periodontal recession or recession of less than 1 mm of height |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients are selected during a dental consultation.
Key inclusion criteria (10 listed)
- patients aged from 20 to 50 years
- patients with recession of more than 1mm
- patient with good health
- patients who aggreed to participate to the study
- patients aged from 20 to 50 years
Key exclusion criteria (5 listed)
- patients with periodontitis
- patients with recession of Class III and IV of modified Miller classification
- patients with previous muco-gingival surgery
- patients pregnant, breatheeding
- patients refusing to participate to the study
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 |
|---|---|---|
| Clinical examination of gingival tissuesMeasure of the periodontal recession | Other | Case -, Control- |
Primary outcome
Evaluation of periodontal recession severity
Time frame: Observation at day 1
Measure of the height and the width of periodontal recession (millimeter)
4 secondary outcomes
Number of recessions for each patient
Time frame: Observation at day 1
Associated risk factors
Time frame: Observation at day 1
Number of participants with recession-related adverse events as assessed by questionnaire
Time frame: Observation at day 1
Frequency of periodontal recession according to the modified Miller classifcation
Time frame: Observation at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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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 contact
Catherine BISSON principal investigator
Central Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Recessions, run by Central Hospital, Nancy, France at 5 sites 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 10 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Catherine BISSON (03.83.85.93.59), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of periodontal recession severity (time frame: Observation at day 1). 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 25 Nov 2019.