Peri-Implantitisperiimpl10yNCT07678892
10 Year Follow-up on Reconstructive Bone Procedures for Peri-implantitis
An observational study of Peri-Implantitis, run by Kristianstad University at 1 site in Sweden.
Trial summary
The purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Treatment with a bone graft and a membrane and Treatment with a bone graft
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2000to 1 Jan 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with at least one dental implant with peri-implantitis
Who may be able to join
- An implant demonstrating a progressive bone loss of ≥ 3 threads ( ≥ 1,8 mm) following the first year of healing
- A vertical component needed to be present at the surgical intervention in order to justify the use of a bone augmentation procedure
- Bleeding on probing and/or suppuration should also be present
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 10 Year Follow-up After Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study
The purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and determine wheter one treatment strategy provided superior long-term outcomes.
Participants were invited for clinical and radiographic examinations of the previously treated implant. Clinical assessments included probing pocket depth measurements, evaluation of bleeding on probing, presence of suppuration, and radiographic assessment of peri-implant bone levels.
Read the detailed description
The objective of this 10-year observational follow-up study was to investigate the long-term clinical and radiographic outcomes of reconstructive surgical treatment and to evaluate potential differences between two reconstructive treatment protocols.
The study population consisted of patients previously treated for per-implantitis using one of the following approaches.
Group 1: Surgical treatment using a bone substitute material (Algipor) combined with a barrier membrane (Osseoquest)
Group 2: Surgical treatment using a bone substitute materail alone (Algipor)
At the time of treatment, all patients received systemic antibiotic therapy consisting of Amoxicillin 375 mg three times daily and Metronidazole 400 mg twice daily for 10 days, initiated one day before surgery.
The study aimed to provide further knowledge regarding the long-term effectiveness and stability of reconstructive peri-implantitis treatment and to investigate potential differences between the two treatment modalities.
Following surgery all patients participated in a structured supportive maintanance program with supportive periodontal therapy every third month and annual clinical evaluations.
At the 10 year follow-up examination, the implant(s) was assessed clinically and radiographically. Clinical parameters included probing pocket depht, bleeding on probing, suppuration, plaque accumulation and implant survival. Probing measurements were performed using a standardized probing force of 0.25 N with a calibrated periodontal probe.
Bleeding scores were recorded at four sites per implant using the following scale:
0=no bleeding
- bleeding point
- bleeding line
- drop of blood
Plaque accumulation was recorded as present or absent, following plaque disclosure.
To minimize examiner variability, all clinical examinations was performed by the same periodontist.
The primary outcome measures were radiographic bone fill and changes in probing pocket depth at treated implant sites. Secondary outcome measures included bleeding on probing, suppuration, plaque scores, and implant survival.
Statistical analyses were performed using parametric or non-parametric methods depending on data distribution. Statistical significance was defined as p< 0.05.
Patients received both oral and written information regarding the study and provided written informed consent prior to participation. Participation was voluntary and the participants could withdraw from the study at any time without consequences. The study had received approval from the appropiate ethical reiew authority.
- Conditions
- Peri-Implantitis
- Being tested
- Treatment with a bone graft and a membrane, Treatment with a bone graft
- Keywords
- peri.implantitis, reconstructive surgery, long time follo-up
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with a bone graft and a membraneProcedure or surgery
Dental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane
Treatment with a bone graftProcedure or surgery
Dental, implants with a diagnosis of peri.implantitis treated with reconstructive surgery and a bone graft alone
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Bone reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest) Receives: Procedure: Treatment with a bone graft and a membrane | |
| Group 2 | Bone reconstructive surgery with a bone graft material (Algipor) Receives: Procedure: Treatment with a bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone fill
Radographic bone fill measured mesial and distal in mm and percent at the implant on an intra-oral radiograph. Measurements will be performed by a blinded radiologist in mm and percent
Measured: 10 years after surgical reconstrucyive bone procedures
Secondary outcomes (1)
Probing pocket depths changes
Changes in probing pocket depths at the implant measured at four sites in mm
Measured: 10 years after surgical reconstructive bone procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Mar 2000
- Primary completion1 Jan 2013
- Study completion1 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristianstad University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viveca Wallin Bengtsson, Kristianstad University
- Investigators
- Ann-Marie R Jansåker, Study director, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678892
- Sponsor's protocol ID
- P-I reconstructive surg 10 y
- Acronym
- periimpl10y
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be shared upon request
Publications
Roos-Jansaker AM, Persson GR, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a 5-year follow-up. J Clin Periodontol. 2014 Nov;41(11):1108-14. doi: 10.1111/jcpe.12308. Epub 2014 Oct 17.
PubMed 25195613Roos-Jansaker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13.
PubMed 21488935Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a prospective cohort study. J Clin Periodontol. 2007 Jul;34(7):625-32. doi: 10.1111/j.1600-051X.2007.01102.x.
PubMed 17555414
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 10 Year Follow-up After Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Membrane: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07678892
- Acronym / sponsor ID
- periimpl10y / P-I reconstructive surg 10 y
- Conditions
- Peri-Implantitis
- Keywords
- peri.implantitis, reconstructive surgery, long time follo-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kristianstad UniversityUniversity, hospital or other
- Study start
- 1 Mar 2000 (actual)
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 1 Jan 2013 (actual)
- First posted
- 1 Jul 2026 (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 purpose of this 10 year observational follow-up study was to evaluate the long-term outcomes of reconstructive surgical treatment of peri-implantitis. Two treatment approaches have been compared using a bone substitute with or without a resorbable membrane.The objective was to assess their effectiveness and determine wheter one treatment strategy provided superior long-term outcomes.
Participants were invited for clinical and radiographic examinations of the previously treated implant. Clinical assessments included probing pocket depth measurements, evaluation of bleeding on probing, presence of suppuration, and radiographic assessment of peri-implant bone levels.
Detailed description
The objective of this 10-year observational follow-up study was to investigate the long-term clinical and radiographic outcomes of reconstructive surgical treatment and to evaluate potential differences between two reconstructive treatment protocols.
The study population consisted of patients previously treated for per-implantitis using one of the following approaches.
Group 1: Surgical treatment using a bone substitute material (Algipor) combined with a barrier membrane (Osseoquest)
Group 2: Surgical treatment using a bone substitute materail alone (Algipor)
At the time of treatment, all patients received systemic antibiotic therapy consisting of Amoxicillin 375 mg three times daily and Metronidazole 400 mg twice daily for 10 days, initiated one day before surgery.
The study aimed to provide further knowledge regarding the long-term effectiveness and stability of reconstructive peri-implantitis treatment and to investigate potential differences between the two treatment modalities.
Following surgery all patients participated in a structured supportive maintanance program with supportive periodontal therapy every third month and annual clinical evaluations.
At the 10 year follow-up examination, the implant(s) was assessed clinically and radiographically. Clinical parameters included probing pocket depht, bleeding on probing, suppuration, plaque accumulation and implant survival. Probing measurements were performed using a standardized probing force of 0.25 N with a calibrated periodontal probe.
Bleeding scores were recorded at four sites per implant using the following scale:
0=no bleeding
- bleeding point
- bleeding line
- drop of blood
Plaque accumulation was recorded as present or absent, following plaque disclosure.
To minimize examiner variability, all clinical examinations was performed by the same periodontist.
The primary outcome measures were radiographic bone fill and changes in probing pocket depth at treated implant sites. Secondary outcome measures included bleeding on probing, suppuration, plaque scores, and implant survival.
Statistical analyses were performed using parametric or non-parametric methods depending on data distribution. Statistical significance was defined as p< 0.05.
Patients received both oral and written information regarding the study and provided written informed consent prior to participation. Participation was voluntary and the participants could withdraw from the study at any time without consequences. The study had received approval from the appropiate ethical reiew authority.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Treatment with a bone graft and a membraneBone reconstructive surgery with a bone graft material (Algipor) and a resorbable membrane (Osseoquest) |
| Group 2 | – | Procedure: Treatment with a bone graftBone reconstructive surgery with a bone graft material (Algipor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with at least one dental implant with peri-implantitis
Key inclusion criteria (3 listed)
- An implant demonstrating a progressive bone loss of ≥ 3 threads ( ≥ 1,8 mm) following the first year of healing
- A vertical component needed to be present at the surgical intervention in order to justify the use of a bone augmentation procedure
- Bleeding on probing and/or suppuration should also be present
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 |
|---|---|---|
| Treatment with a bone graft and a membraneDental implants with a diagnosis of peri-implantitis treated with reconstructive surgery and a bone graft and a membrane | Procedure or surgery | Group 1 |
| Treatment with a bone graftDental, implants with a diagnosis of peri.implantitis treated with reconstructive surgery and a bone graft alone | Procedure or surgery | Group 2 |
Primary outcome
Bone fill
Time frame: 10 years after surgical reconstrucyive bone procedures
Radographic bone fill measured mesial and distal in mm and percent at the implant on an intra-oral radiograph. Measurements will be performed by a blinded radiologist in mm and percent
1 secondary outcome
Probing pocket depths changes
Time frame: 10 years after surgical reconstructive bone procedures
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 2 Jul 2026.
- Results publication: PubMed 25195613Roos-Jansaker AM, Persson GR, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a 5-year follow-up. J Clin Periodontol. 2014 Nov;41(11):1108-14. doi: 10.1111/jcpe.12308. Epub 2014 Oct 17.
- Results publication: PubMed 21488935Roos-Jansaker AM, Lindahl C, Persson GR, Renvert S. Long-term stability of surgical bone regenerative procedures of peri-implantitis lesions in a prospective case-control study over 3 years. J Clin Periodontol. 2011 Jun;38(6):590-7. doi: 10.1111/j.1600-051X.2011.01729.x. Epub 2011 Apr 13.
- Results publication: PubMed 17555414Roos-Jansaker AM, Renvert H, Lindahl C, Renvert S. Surgical treatment of peri-implantitis using a bone substitute with or without a resorbable membrane: a prospective cohort study. J Clin Periodontol. 2007 Jul;34(7):625-32. doi: 10.1111/j.1600-051X.2007.01102.x.
- Individual participant dataSharing planned: Undecided. May be shared upon request
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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.
Ann-Marie R Jansåker study director
Malmö University
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 Kristianstad University at 1 site in Sweden.
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 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 2 Jul 2026. 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 Sweden. 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?
Bone fill (time frame: 10 years after surgical reconstrucyive bone procedures). 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 NCT07678892, which also lists 3 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 2 Jul 2026.