PeriodontitisNCT03841656
Influence of Gum Disease Treatment on Long-term Dental Implant Success
An observational study of Periodontitis, run by University Hospital, Strasbourg, France.
Trial summary
The aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- PARORISKIMPLANT
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Mar 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.
Who may be able to join
- Patient attending supporting periodontal therapy with at least one implant placed for more than 3 years
- Patient with more than 12 teeth at baseline
- Patient with demographic, periodontal, implant data recording
- patient aged >30 years at Baseline
Who cannot join
- Patient needed antibiotic prophylaxis
- Uncontrolled diabetes
- Systemic inflammatory or autoimmune diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Influence of Periodontal Care Response on Implant Treatment Outcomes at Long-term
The aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. The second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors
- Conditions
- Periodontitis
- Being tested
- PARORISKIMPLANT
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARORISKIMPLANTProcedure or surgery
Patients attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of peri-implantitis as measured by probing depth
The implant has a probing depth more than or equal to 4 mm
Measured: At least 3 years after dental implant placement
Presence of peri-implantitis as measured by erythema
The implant has bleeding on probing
Measured: At least 3 years after dental implant placement
Presence of peri-implantitis as measured by radiographic bone loss
The implant has a radiographic bone loss when compared to previous radiographs
Measured: At least 3 years after dental implant placement
Secondary outcomes (1)
Implant survival
presence of implant on arch Peri-implant mucositis: presence of bleeding on probing
Measured: At least 3 years after dental implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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
- Cohort
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841656
- Sponsor's protocol ID
- 67RC001
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papalou I, Vagia P, Cakir A, Tenenbaum H, Huck O, Davideau JL. Influence of Periodontitis, Implant, and Prosthesis Characteristics on the Peri-Implant Status: A Cross-Sectional Study. Int J Dent. 2022 Feb 7;2022:9984871. doi: 10.1155/2022/9984871. eCollection 2022.
PubMed 35178092
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Periodontal Care Response on Implant Treatment Outcomes at Long-term
- ClinicalTrials.gov ID
- NCT03841656
- Acronym / sponsor ID
- 67RC001
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 15 Feb 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 aim of this study is to evaluate the influence of periodontal care response on long term dental implant success. Investigator's hypothesis is that patients who do not well respond to periodontal care have more chance to develop peri-implant complications at long-term. The second purpose of this study is to evaluate the influence of other local, systemic, behavioral, and implant's related risk factors
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.
Key inclusion criteria (4 listed)
- Patient attending supporting periodontal therapy with at least one implant placed for more than 3 years
- Patient with more than 12 teeth at baseline
- Patient with demographic, periodontal, implant data recording
- patient aged >30 years at Baseline
Key exclusion criteria (3 listed)
- Patient needed antibiotic prophylaxis
- Uncontrolled diabetes
- Systemic inflammatory or autoimmune diseases
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 |
|---|---|---|
| PARORISKIMPLANTPatients attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015. | Procedure or surgery | – |
Primary outcome
Presence of peri-implantitis as measured by probing depth
Time frame: At least 3 years after dental implant placement
The implant has a probing depth more than or equal to 4 mm
Presence of peri-implantitis as measured by erythema
Time frame: At least 3 years after dental implant placement
The implant has bleeding on probing
Presence of peri-implantitis as measured by radiographic bone loss
Time frame: At least 3 years after dental implant placement
The implant has a radiographic bone loss when compared to previous radiographs
1 secondary outcome
Implant survival
Time frame: At least 3 years after dental implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 35178092Papalou I, Vagia P, Cakir A, Tenenbaum H, Huck O, Davideau JL. Influence of Periodontitis, Implant, and Prosthesis Characteristics on the Peri-Implant Status: A Cross-Sectional Study. Int J Dent. 2022 Feb 7;2022:9984871. doi: 10.1155/2022/9984871. eCollection 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by University Hospital, Strasbourg, 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 3 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 15 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier HUCK (00333 ext. 116947, olivier.huck@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of peri-implantitis as measured by probing depth (time frame: At least 3 years after dental implant placement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03841656, which also lists 1 linked publication.
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 15 Feb 2019.