Peri-ImplantitisNCT02860208
Follow-Up After Surgical Treatment of Peri-implantitis
An observational study of Peri-Implantitis, run by Göteborg University.
Trial summary
The objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- 3 years follow-up
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients who received surgical treatment for peri-implantitis during the RCT registered in ClinicalTrials.gov NCT NCT01857804
Who may be able to join
- all patients who received surgical treatment for peri-implantitis for 3 years ago
Who cannot join
- -
About this study
The objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed.
Read the detailed description
The patients enrolled in this prospective study all received surgical treatment for peri-implantitis at one of 2 treatment centres (specialist periodontal practice, Molndal and Gothenburg, Public Dental Health Services, Region Vastra Gotaland, Sweden) and were enrolled between October 2010 and December 2013.). All were treated by experienced periodontists.
Details of the peri-implantitis treatment protocol have been described in a previous publication reporting on the 12-month clinical and radiographic treatment outcomes, registered at ClinicalTrials.gov (NCT01857804) and approved by the Regional Ethical Committee, Gothenburg, Sweden (Dnr. 654-10).
- Conditions
- Peri-Implantitis
- Being tested
- 3 years follow-up
- Keywords
- Peri-Implantitis, Surgical therapy, Follow-up, Supportive peri-implant therapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 years follow-upProcedure or surgery
Examination 3 years after surgical treatment of peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| 3 years follow-up | all patients who received surgical treatment for peri-implantitis during a Randomized and Controlled Trial registered in ClinicalTrials.gov NCT NCT01857804 Receives: Procedure: 3 years follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in treatment success at 3 years post-op
treatment success is defined by pocket closure, no bleeding on probing, bone loss ≤0.5 mm between baseline and 3 years
Measured: baseline (1 year post-op) and 3 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tord Berglundh, Professor, Study chair, Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860208
- Sponsor's protocol ID
- olivier2
- Status last verified
- Dec 2016
- First submitted
- 4 Aug 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sanz M, Chapple IL; Working Group 4 of the VIII European Workshop on Periodontology. Clinical research on peri-implant diseases: consensus report of Working Group 4. J Clin Periodontol. 2012 Feb;39 Suppl 12:202-6. doi: 10.1111/j.1600-051X.2011.01837.x.
PubMed 22533957Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
PubMed 26285807Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.
PubMed 27335316Serino G, Turri A. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans. Clin Oral Implants Res. 2011 Nov;22(11):1214-20. doi: 10.1111/j.1600-0501.2010.02098.x. Epub 2011 Feb 11.
PubMed 21309860Serino G, Turri A, Lang NP. Maintenance therapy in patients following the surgical treatment of peri-implantitis: a 5-year follow-up study. Clin Oral Implants Res. 2015 Aug;26(8):950-956. doi: 10.1111/clr.12418. Epub 2014 May 26.
PubMed 24861154Mettraux GR, Sculean A, Burgin WB, Salvi GE. Two-year clinical outcomes following non-surgical mechanical therapy of peri-implantitis with adjunctive diode laser application. Clin Oral Implants Res. 2016 Jul;27(7):845-9. doi: 10.1111/clr.12689. Epub 2015 Sep 16.
PubMed 26374080
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-Up After Surgical Treatment of Peri-implantitis
- ClinicalTrials.gov ID
- NCT02860208
- Acronym / sponsor ID
- olivier2
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implantitis, Surgical therapy, Follow-up, Supportive peri-implant therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Aug 2016 (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 objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (SPIT) programme was followed.
Detailed description
The patients enrolled in this prospective study all received surgical treatment for peri-implantitis at one of 2 treatment centres (specialist periodontal practice, Molndal and Gothenburg, Public Dental Health Services, Region Vastra Gotaland, Sweden) and were enrolled between October 2010 and December 2013.). All were treated by experienced periodontists.
Details of the peri-implantitis treatment protocol have been described in a previous publication reporting on the 12-month clinical and radiographic treatment outcomes, registered at ClinicalTrials.gov (NCT01857804) and approved by the Regional Ethical Committee, Gothenburg, Sweden (Dnr. 654-10).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 years follow-up | – | Procedure: 3 years follow-upall patients who received surgical treatment for peri-implantitis during a Randomized and Controlled Trial registered in ClinicalTrials.gov NCT NCT01857804 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients who received surgical treatment for peri-implantitis during the RCT registered in ClinicalTrials.gov NCT NCT01857804
Key inclusion criteria (1 listed)
- all patients who received surgical treatment for peri-implantitis for 3 years ago
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| 3 years follow-upExamination 3 years after surgical treatment of peri-implantitis | Procedure or surgery | 3 years follow-up |
Primary outcome
Change from baseline in treatment success at 3 years post-op
Time frame: baseline (1 year post-op) and 3 years post-op
treatment success is defined by pocket closure, no bleeding on probing, bone loss ≤0.5 mm between baseline and 3 years
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 20 Dec 2016.
- Background: PubMed 22533957Sanz M, Chapple IL; Working Group 4 of the VIII European Workshop on Periodontology. Clinical research on peri-implant diseases: consensus report of Working Group 4. J Clin Periodontol. 2012 Feb;39 Suppl 12:202-6. doi: 10.1111/j.1600-051X.2011.01837.x.
- Background: PubMed 26285807Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
- Background: PubMed 27335316Heitz-Mayfield LJA, Salvi GE, Mombelli A, Loup PJ, Heitz F, Kruger E, Lang NP. Supportive peri-implant therapy following anti-infective surgical peri-implantitis treatment: 5-year survival and success. Clin Oral Implants Res. 2018 Jan;29(1):1-6. doi: 10.1111/clr.12910. Epub 2016 Jun 23.
- Background: PubMed 21309860Serino G, Turri A. Outcome of surgical treatment of peri-implantitis: results from a 2-year prospective clinical study in humans. Clin Oral Implants Res. 2011 Nov;22(11):1214-20. doi: 10.1111/j.1600-0501.2010.02098.x. Epub 2011 Feb 11.
- Background: PubMed 24861154Serino G, Turri A, Lang NP. Maintenance therapy in patients following the surgical treatment of peri-implantitis: a 5-year follow-up study. Clin Oral Implants Res. 2015 Aug;26(8):950-956. doi: 10.1111/clr.12418. Epub 2014 May 26.
- Background: PubMed 26374080Mettraux GR, Sculean A, Burgin WB, Salvi GE. Two-year clinical outcomes following non-surgical mechanical therapy of peri-implantitis with adjunctive diode laser application. Clin Oral Implants Res. 2016 Jul;27(7):845-9. doi: 10.1111/clr.12689. Epub 2015 Sep 16.
- Individual participant dataSharing planned: No
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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.
Tord Berglundh, Professor study chair
Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis, run by Göteborg University.
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 1 inclusion and 1 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 20 Dec 2016. 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?
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?
Change from baseline in treatment success at 3 years post-op (time frame: baseline (1 year post-op) and 3 years post-op). 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 NCT02860208, which also lists 6 linked publications.
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 20 Dec 2016.