Peri-ImplantitisNCT03077061
Peri-implantitis - Reconstructive Surgical Therapy
A study testing Open flap debridement and Bone replacement graft in people with Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
Trial summary
The project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 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?
- Open flap debridement and Bone replacement graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2017to 14 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years
- ≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus.
- Confirmed bone loss ≥3 mm at same implant(s)
Who cannot join
- Treated for peri-implantitis during previous 6 months
- Intake of systemic or local antibiotics during previous 6 months
- Systemic conditions affecting peri-implant tissues
- Systemic conditions impeding surgical intervention
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Periodontology, Institute of Odontology
Gothenburg, 40530
About this study
Official title: Reconstructive Surgical Therapy of Peri-implantitis-related Osseous Defects. A Multicenter Randomized Controlled Clinical Trial
The project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be treated with or without bone replacement graft. Outcome measures include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.
Read the detailed description
Objective The overall objective of the project is to evaluate the clinical efficacy of the use of a bone substitute material in reconstructive surgical therapy of peri-implantitis-associated osseous defects.
Hypothesis: The use of a bone substitute material in reconstructive therapy of peri-implantitis increases the likelihood to achieve treatment success.
Relevance for clinical practice The project will provide significant contribution to the understanding of outcomes using reconstructive procedures in treatment of peri-implantitis.
Study population, design and treatment procedures The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients with implants ≥1 year in function and diagnosed with advanced peri-implantitis at ≥1 implants will be enrolled.
Inclusion criteria Age ≥ 18 years
≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus. Confirmed bone loss ≥3 mm at same implant(s)
Exclusion criteria Treated for peri-implantitis during previous 6 months Intake of systemic or local antibiotics during previous 6 months Systemic conditions affecting peri-implant tissues Systemic conditions impeding surgical intervention
Surgical procedures Surgical procedures will be performed one month after a baseline examination and initiation of plaque control. Three days before surgery a 10-day systemic antibiotic regimen will be initiated. Full thickness flaps will be elevated and inflamed tissues will be removed. The implant surfaces will be cleaned with mini-gauze soaked in saline. The osseous defect should be ≤4 mm wide and >3 mm deep. The defect should in addition to the mesial and distal bone walls preferably exhibit at least a lingual or a buccal bone wall. The randomly assigned treatment strategy, stratified for smoking, will be revealed after debridement. Test procedure: The defect will be filled with Bio-Oss Collagen® and the flaps will be sutured to their previous position. Control procedure: Flaps will be sutured to their previous position. Sutures will be removed 2 weeks after treatment, followed by a 6-week control. Clinical examinations will be performed at 6, 12, 24, 36, 48 and 60 months after therapy. Maintenance therapy will be provided based on individual needs.
Clinical assessments One calibrated examiner in each clinical center will perform the assessments. The following variables will be assessed at four sites around the implant: Plaque, probing pocket depth (PPD), bleeding on probing (BoP), probing attachment level (PAL) and recession (REC).
Treatment success Treatment success will be defined as the absence of BoP/Pus, PPD ≤5 mm and ≤1 mm recession. Peri-implant sites showing BoP and PPD ≥6 mm at re-examination will be scheduled for further treatment. Patient-related outcome variables will be assessed at baseline and follow-up and include esthetic and functional appreciation, pain or discomfort.
Radiographic assessments Intra-oral radiographs will be obtained prior to surgery (baseline) and at 1-, 3- and 5-year re-examinations. Analysis of radiographs will be performed by specialists in oral-maxillofacial radiology. The examiners will be blinded to treatment procedures. The assessment will include defect fill and crestal bone support.
Power calculation A total of 122 patients (61 per group) will provide a power of 80% with alpha set at 0.05 to detect a difference of 1 mm in mean PPD change between groups, given a SD of 1.97 (Carcuac et al., 2016). 140 individuals will be included to compensate for drop-out.
Data analysis Mean changes for the various variables and the proportion of sites fulfilling the criteria for treatment success will be calculated. A multilevel model with the clinical center as the highest level and the implant as the lowest will be built to test the influence of measured factors on the outcomes and to compensate for potential clustering of data. Data analysis including multilevel modeling will be conducted in collaboration with a biostatistician.
Schedule of investigational events
- Screening and identification of subjects.
- Baseline clinical examination of implants selected for the study. Case presentation and reinforcement of self-performed plaque control. Assessment of PROM. Professional mechanical infection control.
- Radiographic examination prior to surgical therapy (within 4 weeks).
- Surgical therapy including test and control treatment procedures at study sites.
- 2 weeks - suture removal. Assessment of PROM.
- 6 weeks - professional supra-mucosal cleaning and reinforcement of oral hygiene.
- 6 months - clinical examination.
- 12 months - clinical and radiological examination. Assessment of PROM.
- 24 months - clinical examination.
- 36 months - clinical and radiological examination. Assessment of PROM.
- 48 months - clinical examination.
- 60 months - clinical and radiological examination. Assessment of PROM.
- Conditions
- Peri-Implantitis
- Being tested
- Open flap debridement, Bone replacement graft
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridementProcedure or surgery
Open flap debridement using saline as irrigation
Bone replacement graftDevice
Also called Bio-Oss Collagen®
Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®.
| Study group | Role | What they receive |
|---|---|---|
| Control - Open flap debridement | Active comparator | The surgical procedure includes flap elevation, debridement of the peri-implant defect and decontamination of the implant surfaces using saline for irrigation. Flaps are replaced in their original position and carefully sutured. Patients are provided with post-surgical information and thereafter called in for regular follow-up visits. Receives: Procedure: Open flap debridement |
| Test - Bone replacement graft | Experimental | The surgical procedure is identical to the control procedure with the exception of the application of the bone replacement graft. Following decontamination, Bio-Oss Collagen® is placed into the peri-implant bony defect. Flaps are carefully sutured and patients are provided with the same information and follow-up as patients in the control group. Receives: Procedure: Open flap debridement; Device: Bone replacement graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success (year 1)
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
Measured: Assessed at year 1
Treatment success (year 3)
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
Measured: Assessed at year 3
Treatment success (year 5)
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm
Measured: Assessed at year 5
Secondary outcomes (2)
Radiographic outcomes
Defect fill and crestal bone support
Measured: Assessed at 1, 3 and 5 years
Patient-reported outcomes
Patient-reported outcomes assessed by questionnaire and in relation to baseline
Measured: Prior to intervention and at 1, 3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Apr 2017
- Primary completion14 Mar 2022
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a two-arm randomized clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Sponsor
- Investigators
- Tord Berglundh, Professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077061
- Sponsor's protocol ID
- 1192-16
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2017
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.
PubMed 21092053Carcuac O, Abrahamsson I, Charalampakis G, Berglundh T. The effect of the local use of chlorhexidine in surgical treatment of experimental peri-implantitis in dogs. J Clin Periodontol. 2015 Feb;42(2):196-203. doi: 10.1111/jcpe.12332. Epub 2015 Jan 20.
PubMed 25385434Carcuac 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 26285807Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.
PubMed 26701919Jepsen K, Jepsen S, Laine ML, Anssari Moin D, Pilloni A, Zeza B, Sanz M, Ortiz-Vigon A, Roos-Jansaker AM, Renvert S. Reconstruction of Peri-implant Osseous Defects: A Multicenter Randomized Trial. J Dent Res. 2016 Jan;95(1):58-66. doi: 10.1177/0022034515610056. Epub 2015 Oct 8.
PubMed 26450511Khoshkam V, Chan HL, Lin GH, MacEachern MP, Monje A, Suarez F, Giannobile WV, Wang HL. Reconstructive procedures for treating peri-implantitis: a systematic review. J Dent Res. 2013 Dec;92(12 Suppl):131S-8S. doi: 10.1177/0022034513509279. Epub 2013 Oct 24.
PubMed 24158331Roccuzzo M, Gaudioso L, Lungo M, Dalmasso P. Surgical therapy of single peri-implantitis intrabony defects, by means of deproteinized bovine bone mineral with 10% collagen. J Clin Periodontol. 2016 Mar;43(3):311-8. doi: 10.1111/jcpe.12516. Epub 2016 Mar 9.
PubMed 26800389Wohlfahrt JC, Lyngstadaas SP, Ronold HJ, Saxegaard E, Ellingsen JE, Karlsson S, Aass AM. Porous titanium granules in the surgical treatment of peri-implant osseous defects: a randomized clinical trial. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):401-10.
PubMed 22442781
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Surgical Therapy of Peri-implantitis-related Osseous Defects. A Multicenter Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03077061
- Acronym / sponsor ID
- 1192-16
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 10 Mar 2017 (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 project will evaluate the potential benefit of the use of bone replacement graft as an adjunct to surgical therapy of peri-implantitis. The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients diagnosed with peri-implantitis will randomly assigned to be treated with or without bone replacement graft. Outcome measures include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.
Detailed description
Objective The overall objective of the project is to evaluate the clinical efficacy of the use of a bone substitute material in reconstructive surgical therapy of peri-implantitis-associated osseous defects.
Hypothesis: The use of a bone substitute material in reconstructive therapy of peri-implantitis increases the likelihood to achieve treatment success.
Relevance for clinical practice The project will provide significant contribution to the understanding of outcomes using reconstructive procedures in treatment of peri-implantitis.
Study population, design and treatment procedures The project will be conducted as a two-armed randomized controlled clinical trial of 5-year duration in 7 clinical centers. 140 systemically healthy patients with implants ≥1 year in function and diagnosed with advanced peri-implantitis at ≥1 implants will be enrolled.
Inclusion criteria Age ≥ 18 years
≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus. Confirmed bone loss ≥3 mm at same implant(s)
Exclusion criteria Treated for peri-implantitis during previous 6 months Intake of systemic or local antibiotics during previous 6 months Systemic conditions affecting peri-implant tissues Systemic conditions impeding surgical intervention
Surgical procedures Surgical procedures will be performed one month after a baseline examination and initiation of plaque control. Three days before surgery a 10-day systemic antibiotic regimen will be initiated. Full thickness flaps will be elevated and inflamed tissues will be removed. The implant surfaces will be cleaned with mini-gauze soaked in saline. The osseous defect should be ≤4 mm wide and >3 mm deep. The defect should in addition to the mesial and distal bone walls preferably exhibit at least a lingual or a buccal bone wall. The randomly assigned treatment strategy, stratified for smoking, will be revealed after debridement. Test procedure: The defect will be filled with Bio-Oss Collagen® and the flaps will be sutured to their previous position. Control procedure: Flaps will be sutured to their previous position. Sutures will be removed 2 weeks after treatment, followed by a 6-week control. Clinical examinations will be performed at 6, 12, 24, 36, 48 and 60 months after therapy. Maintenance therapy will be provided based on individual needs.
Clinical assessments One calibrated examiner in each clinical center will perform the assessments. The following variables will be assessed at four sites around the implant: Plaque, probing pocket depth (PPD), bleeding on probing (BoP), probing attachment level (PAL) and recession (REC).
Treatment success Treatment success will be defined as the absence of BoP/Pus, PPD ≤5 mm and ≤1 mm recession. Peri-implant sites showing BoP and PPD ≥6 mm at re-examination will be scheduled for further treatment. Patient-related outcome variables will be assessed at baseline and follow-up and include esthetic and functional appreciation, pain or discomfort.
Radiographic assessments Intra-oral radiographs will be obtained prior to surgery (baseline) and at 1-, 3- and 5-year re-examinations. Analysis of radiographs will be performed by specialists in oral-maxillofacial radiology. The examiners will be blinded to treatment procedures. The assessment will include defect fill and crestal bone support.
Power calculation A total of 122 patients (61 per group) will provide a power of 80% with alpha set at 0.05 to detect a difference of 1 mm in mean PPD change between groups, given a SD of 1.97 (Carcuac et al., 2016). 140 individuals will be included to compensate for drop-out.
Data analysis Mean changes for the various variables and the proportion of sites fulfilling the criteria for treatment success will be calculated. A multilevel model with the clinical center as the highest level and the implant as the lowest will be built to test the influence of measured factors on the outcomes and to compensate for potential clustering of data. Data analysis including multilevel modeling will be conducted in collaboration with a biostatistician.
Schedule of investigational events
- Screening and identification of subjects.
- Baseline clinical examination of implants selected for the study. Case presentation and reinforcement of self-performed plaque control. Assessment of PROM. Professional mechanical infection control.
- Radiographic examination prior to surgical therapy (within 4 weeks).
- Surgical therapy including test and control treatment procedures at study sites.
- 2 weeks - suture removal. Assessment of PROM.
- 6 weeks - professional supra-mucosal cleaning and reinforcement of oral hygiene.
- 6 months - clinical examination.
- 12 months - clinical and radiological examination. Assessment of PROM.
- 24 months - clinical examination.
- 36 months - clinical and radiological examination. Assessment of PROM.
- 48 months - clinical examination.
- 60 months - clinical and radiological examination. Assessment of PROM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is designed as a two-arm randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Control - Open flap debridement | Active comparator | Procedure: Open flap debridementThe surgical procedure includes flap elevation, debridement of the peri-implant defect and decontamination of the implant surfaces using saline for irrigation. Flaps are replaced in their original position and carefully sutured. Patients are provided with post-surgical information and thereafter called in for regular follow-up visits. |
| Test - Bone replacement graft | Experimental | Procedure: Open flap debridement, Device: Bone replacement graftThe surgical procedure is identical to the control procedure with the exception of the application of the bone replacement graft. Following decontamination, Bio-Oss Collagen® is placed into the peri-implant bony defect. Flaps are carefully sutured and patients are provided with the same information and follow-up as patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- ≥1 implant (≥1 year of function) presenting with PPD ≥7 mm and BoP/Pus.
- Confirmed bone loss ≥3 mm at same implant(s)
Key exclusion criteria (4 listed)
- Treated for peri-implantitis during previous 6 months
- Intake of systemic or local antibiotics during previous 6 months
- Systemic conditions affecting peri-implant tissues
- Systemic conditions impeding surgical intervention
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 |
|---|---|---|
| Open flap debridementOpen flap debridement using saline as irrigation | Procedure or surgery | Control - Open flap debridement, Test - Bone replacement graft |
| Bone replacement graftAlso: Bio-Oss Collagen®Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®. | Device | Test - Bone replacement graft |
Primary outcome
Treatment success (year 1)
Time frame: Assessed at year 1
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
Treatment success (year 3)
Time frame: Assessed at year 3
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm recession of mucosal margin
Treatment success (year 5)
Time frame: Assessed at year 5
Absence of bleeding/suppuration on probing, probing depth ≤5 mm and ≤1 mm
2 secondary outcomes
Radiographic outcomes
Time frame: Assessed at 1, 3 and 5 years
Patient-reported outcomes
Time frame: Prior to intervention and at 1, 3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 21092053Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.
- Background: PubMed 25385434Carcuac O, Abrahamsson I, Charalampakis G, Berglundh T. The effect of the local use of chlorhexidine in surgical treatment of experimental peri-implantitis in dogs. J Clin Periodontol. 2015 Feb;42(2):196-203. doi: 10.1111/jcpe.12332. Epub 2015 Jan 20.
- 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 26701919Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.
- Background: PubMed 26450511Jepsen K, Jepsen S, Laine ML, Anssari Moin D, Pilloni A, Zeza B, Sanz M, Ortiz-Vigon A, Roos-Jansaker AM, Renvert S. Reconstruction of Peri-implant Osseous Defects: A Multicenter Randomized Trial. J Dent Res. 2016 Jan;95(1):58-66. doi: 10.1177/0022034515610056. Epub 2015 Oct 8.
- Background: PubMed 24158331Khoshkam V, Chan HL, Lin GH, MacEachern MP, Monje A, Suarez F, Giannobile WV, Wang HL. Reconstructive procedures for treating peri-implantitis: a systematic review. J Dent Res. 2013 Dec;92(12 Suppl):131S-8S. doi: 10.1177/0022034513509279. Epub 2013 Oct 24.
- Background: PubMed 26800389Roccuzzo M, Gaudioso L, Lungo M, Dalmasso P. Surgical therapy of single peri-implantitis intrabony defects, by means of deproteinized bovine bone mineral with 10% collagen. J Clin Periodontol. 2016 Mar;43(3):311-8. doi: 10.1111/jcpe.12516. Epub 2016 Mar 9.
- Background: PubMed 22442781Wohlfahrt JC, Lyngstadaas SP, Ronold HJ, Saxegaard E, Ellingsen JE, Karlsson S, Aass AM. Porous titanium granules in the surgical treatment of peri-implant osseous defects: a randomized clinical trial. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):401-10.
- 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 principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open flap debridement and Bone replacement graft in people with Peri-Implantitis, run by Göteborg 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 4 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Treatment success (year 1) (time frame: Assessed at year 1). 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 NCT03077061, which also lists 8 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 10 Sep 2026.