Periodontitis, AdultPERIODONTITISNCT05065034
Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments
An observational study of Periodontitis, Adult, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Adult
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to 25 Jun 2023
- 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
- Adult, Older adult
Study population: Patient adult treated for periodontitis
Who may be able to join
- Patient over 18 years old
- Patient treated for periodontitis between 01/01/2012 and 07/31/2021
- Patient whose medical and periodontal file contains all the elements necessary for data analysis
- Subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research.
Who cannot join
- Patient who expressed his opposition to participating in the study
- Patient without periodontitis
- Patient smoking more than 10 cigarettes / day
- Patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment
- Impossibility of giving the subject informed information
- Subject under safeguard of justice
- Subject under guardianship or guardianship
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Jean-Luc DAVIDEAU, MD, PhD, 33 3 88 11 69 47, jean.luc.davideau@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments: Impact of Risk Factors and Treatment Characteristics
Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.
- Conditions
- Periodontitis, Adult
- Keywords
- Periodontitis, Inflammatory diseases, Periodontal, Teeth, Aesthetic morbidity, Cardiovascular risk, Supragingival, Subgingival, Biofilms, Prosthetic restorations
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What is being measured
The primary outcome is the main question the study is designed to answer.
A retrospective study of the use of antibiotic therapy on the short and long-term results of periodontitis treatments
Measured: Files analysed retrospectively from January 01, 2012 to July 07, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start29 Sep 2021
- Primary completion25 Jun 2023 (estimated)
- Study completion25 Jun 2023 (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 University Hospital, Strasbourg, 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 only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc DAVIDEAU, MD, PhD, Principal investigator, Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065034
- Sponsor's protocol ID
- 8333
- Acronym
- PERIODONTITIS
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- 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 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antibiotic Therapy on the Short and Long-term Results of Periodontitis Treatments: Impact of Risk Factors and Treatment Characteristics
- ClinicalTrials.gov ID
- NCT05065034
- Acronym / sponsor ID
- PERIODONTITIS / 8333
- Conditions
- Periodontitis, Adult
- Keywords
- Periodontitis, Inflammatory diseases, Periodontal, Teeth, Aesthetic morbidity, Cardiovascular risk, Supragingival, Subgingival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 25 Jun 2023 (estimated)
- Study completion
- 25 Jun 2023 (estimated)
- First posted
- 1 Oct 2021 (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.
Antibiotics are currently used in periodontology to specifically target the most pathogenic bacteria in subgingival biofilms and to improve treatments. The multiplicity of protocols / dosages tested and the variability of the results did not make it possible to reach an international consensus on antibiotic therapy and its cost / benefit ratio, in particular with regard to the significant side effects of taking antibiotics (resistance bacterial). The care environment as well as the clinical, biological and microbiological parameters can strongly influence the results in usual treatment.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient adult treated for periodontitis
Key inclusion criteria (4 listed)
- Patient over 18 years old
- Patient treated for periodontitis between 01/01/2012 and 07/31/2021
- Patient whose medical and periodontal file contains all the elements necessary for data analysis
- Subject not having expressed, after information, his opposition to the reuse of his medical data for the purposes of this research.
Key exclusion criteria (7 listed)
- Patient who expressed his opposition to participating in the study
- Patient without periodontitis
- Patient smoking more than 10 cigarettes / day
- Patient presenting a dilapidated oral state (untreated caries, unrestored teeth), oral infectious foci whose management requires antibiotic treatment during the initial treatment
- Impossibility of giving the subject informed information
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
A retrospective study of the use of antibiotic therapy on the short and long-term results of periodontitis treatments
Time frame: Files analysed retrospectively from January 01, 2012 to July 07, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Jean-Luc DAVIDEAU, MD, PhD principal investigator
Service de Médecine et de Chirurgie Bucco-Dentaires - Hôpitaux Universitaires de Strasbourg
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 University Hospital, Strasbourg, 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 4 inclusion and 7 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 12 Oct 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 Jean-Luc DAVIDEAU, MD, PhD (33 3 88 11 69 47, jean.luc.davideau@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A retrospective study of the use of antibiotic therapy on the short and long-term results of periodontitis treatments (time frame: Files analysed retrospectively from January 01, 2012 to July 07, 2021 will be examined]). 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 12 Oct 2021.