Peri-ImplantitisNCT05772078
Compliance and Cumulative Interceptive Rate After Therapy of Peri-implantitis
An observational study of Peri-Implantitis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
Peri-implantitis is a plaque-mediated inflammatory condition featured by progressive bone loss. This entity jeopardizes the longevity of dental implants, thus impacting negatively on the quality of life of patients. Moreover, peri-implantitis is suggested to lead to an increased systemic status of inflammation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Assess compliance rate and demographics
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2023to 30 Oct 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that underwent therapy of peri-implantitis and were recommended to SPT
Who may be able to join
- Patients that underwent treatment of peri-implantitis
- >12 months of follow-up after therapy
- Patients managed in our center
Who cannot join
- Patients that were managed in other centers
- Patients that have incomplete records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance Rate After Therapy of Peri-implantitis: Retrospective Study
Peri-implantitis is a plaque-mediated inflammatory condition featured by progressive bone loss. This entity jeopardizes the longevity of dental implants, thus impacting negatively on the quality of life of patients. Moreover, peri-implantitis is suggested to lead to an increased systemic status of inflammation. This may rise the susceptibility to experience life-threating conditions. Therefore, peri-implant infections must be promptly diagnosed and eliminated.
Aiming at resolving the inflammation, several options are advised to remove the infection. Accordingly, implant removal or therapeutic manoeuvres to stablish a healthy ecosystem in the peri-implant environment have been suggested. While the former proved being more predictable, the later demonstrated being more conservative. Indeed, implant removal is commonly associated with regenerative procedures of the alveolar bone deformity that often demand time and is more costly. Anyways, disease severity, implant expendability for biomechanical reasons or esthetic demand seem to be few of the leading aspects in the decision-making process on maintaining or extracting implant showing peri-implant lesions.
Supportive maintenance care (SPT) was shown to be key in preventing disease recurrence. Nonetheless, the compliance of these patients is often erratic. In fact, it is yet unknown the rate of compliance after therapy. Therefore, the goal of this study is to assess the rate and confounders for compliance.
- Conditions
- Peri-Implantitis
- Being tested
- Assess compliance rate and demographics
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess compliance rate and demographicsOther
Records to evaluate attendance rate
| Study group | Role | What they receive |
|---|---|---|
| Compliers | Attending to SPT every 4-6 months Receives: Other: Assess compliance rate and demographics | |
| Erratic compliers | Attending to SPT once a year or sporadically Receives: Other: Assess compliance rate and demographics | |
| Non compliers | Non-attenders to SPT Receives: Other: Assess compliance rate and demographics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate
How many patients are complete compliers
Measured: 1 to 6 years of follow-up
Secondary outcomes (1)
Demographics
Evaluate the patient-related features affecting compliance
Measured: 1 to 6 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2023
- Study completion30 Oct 2023
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 Peri-ImplantitisStudies of the same condition, open and under way.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Monje, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Investigators
- Mamen Tomé, DH, Study chair, Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772078
- Sponsor's protocol ID
- 20230208
- Status last verified
- Oct 2023
- First submitted
- 6 Mar 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication
Publications
Monje A, Galindo-Fernandez P, Nart J. Supportive therapy following peri-implantitis treatment: A retrospective study on compliance. Clin Oral Implants Res. 2024 Jun;35(6):621-629. doi: 10.1111/clr.14257. Epub 2024 Mar 26.
PubMed 38530213
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance Rate After Therapy of Peri-implantitis: Retrospective Study
- ClinicalTrials.gov ID
- NCT05772078
- Acronym / sponsor ID
- 20230208
- Conditions
- Peri-Implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 16 Mar 2023 (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.
Peri-implantitis is a plaque-mediated inflammatory condition featured by progressive bone loss. This entity jeopardizes the longevity of dental implants, thus impacting negatively on the quality of life of patients. Moreover, peri-implantitis is suggested to lead to an increased systemic status of inflammation. This may rise the susceptibility to experience life-threating conditions. Therefore, peri-implant infections must be promptly diagnosed and eliminated.
Aiming at resolving the inflammation, several options are advised to remove the infection. Accordingly, implant removal or therapeutic manoeuvres to stablish a healthy ecosystem in the peri-implant environment have been suggested. While the former proved being more predictable, the later demonstrated being more conservative. Indeed, implant removal is commonly associated with regenerative procedures of the alveolar bone deformity that often demand time and is more costly. Anyways, disease severity, implant expendability for biomechanical reasons or esthetic demand seem to be few of the leading aspects in the decision-making process on maintaining or extracting implant showing peri-implant lesions.
Supportive maintenance care (SPT) was shown to be key in preventing disease recurrence. Nonetheless, the compliance of these patients is often erratic. In fact, it is yet unknown the rate of compliance after therapy. Therefore, the goal of this study is to assess the rate and confounders for compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Compliers | – | Other: Assess compliance rate and demographicsAttending to SPT every 4-6 months |
| Erratic compliers | – | Other: Assess compliance rate and demographicsAttending to SPT once a year or sporadically |
| Non compliers | – | Other: Assess compliance rate and demographicsNon-attenders to SPT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that underwent therapy of peri-implantitis and were recommended to SPT
Key inclusion criteria (3 listed)
- Patients that underwent treatment of peri-implantitis
- >12 months of follow-up after therapy
- Patients managed in our center
Key exclusion criteria (2 listed)
- Patients that were managed in other centers
- Patients that have incomplete records
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 |
|---|---|---|
| Assess compliance rate and demographicsRecords to evaluate attendance rate | Other | Compliers, Erratic compliers, Non compliers |
Primary outcome
Compliance rate
Time frame: 1 to 6 years of follow-up
How many patients are complete compliers
1 secondary outcome
Demographics
Time frame: 1 to 6 years of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 38530213Monje A, Galindo-Fernandez P, Nart J. Supportive therapy following peri-implantitis treatment: A retrospective study on compliance. Clin Oral Implants Res. 2024 Jun;35(6):621-629. doi: 10.1111/clr.14257. Epub 2024 Mar 26.
- Individual participant dataSharing planned: Undecided. Publication
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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.
Mamen Tomé, DH study chair
Assistant
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 Peri-Implantitis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 30 Apr 2024. 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 Spain. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compliance rate (time frame: 1 to 6 years of follow-up). 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 NCT05772078, 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 30 Apr 2024.