Peri-implantitisNCT02375750
Treatment of Peri-implantitis Lesions by Using Biomaterial
A study testing GBO and GBG and Standard treatment in people with Peri-implantitis, run by Geistlich Pharma AG at 1 site in Sweden.
Trial summary
The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease. 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?
- GBO and GBG and Standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- age 18 years or older
- Presence of peri-implantitis
- A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
- Clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site.
- During surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present.
- The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included.
- Implants included in the study must have been in function for more than 12 months.
- Ability to fully understand the nature of the proposed surgery and ability to sign an Ethics Committee-approved informed consent form
Who cannot join
- Subjects with diabetes mellitus (HbA1c > 7.0)
- Subjects taking prednisone or other anti-inflammatory prescription drug
- Subjects taking medications known to have effects on gingival growth
- If the same patient has more than one defect meeting the inclusion criteria, only one such defect will be included in the study
- General contraindications for dental and/or surgical treatments
- Smokers (> 10 cigarettes per day).
Show all 9Show fewer
- Pregnant or lactating women
- Allergy to collagen
- Inability to consent for participation in the study and/or to accept the proposed
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Kristianstad University, Department of Health Sciences
Kristianstad, 29188
About this study
Official title: Surgical Treatment of Peri-implantitis Lesions, With or Without the Placement of a Bone Substitute and a Collagen Membrane. A Randomized Clinical Trial
The primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.
Read the detailed description
Patient who will considered eligible at the screening visit will undergo surgical treatment procedure within 2 weeks. At the day of the surgery the patients will be randomized into the 2 treatment groups.
The subjects will be then prescribed postoperative antibiotics (Azitromax 500 mg day one and 250 mg day 2-4).
Post-operative pain will be controlled with Ibuprofen (400mg x 3) for two days to all subjects. Subjects will rinse twice daily with Chlorhexidine mouth rinse and use modified oral hygiene procedures during the first 5 weeks of healing. Subjects will receive professional prophylaxis as required.
Subjects will be instructed on appropriate oral hygiene throughout the study and will be given appropriate oral hygiene instructions. Instructions on post-operative care will be repeated at each visit. In particular the following points have to be covered during the first month after surgery: Chlorhexidine rinses, avoidance of brushing, usage of interdental cleaning devices, avoidance of chewing on or trauma to the treated area. In addition subjects will be instructed not to smoke more than 10 cigarettes per day during the entire study period and not to consume alcohol during antibiotic therapy.
Sutures will be removed after 14 days. Photos will be taken during the whole study to document the healing process.
Further follow up visits will be scheduled 6 weeks and 3,6,9,12 months post-surgery.
- Conditions
- Peri-implantitis
- Being tested
- GBO and GBG, Standard treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBO and GBGDevice
Application of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant
Standard treatmentOther
Removal of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing
| Study group | Role | What they receive |
|---|---|---|
| GBO and GBG | Experimental | 0.2 g-0,5 g GBO and 1 GBG once after decontamination of implant surface Receives: Device: GBO and GBG |
| Standard treatment | Active comparator | Decontamination of surface of implant Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the dimensions of the bone defect
Measured: 6 months, 1 year
Secondary outcomes (4)
Change in pocket depth
Measured: 3 months,6months, 9 months,12months
Change in gingival inflammation
Measured: 3 months,6months, 9 months,12months
Changes in recession of the mucosal margin
Measured: 3 months,6months, 9 months,12months
Subject satisfaction with the outcome at the study end
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Renvert, Professor, Principal investigator, Department of Health Sciences, Kristianstad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375750
- Sponsor's protocol ID
- GS13530231
- Status last verified
- Feb 2019
- First submitted
- 7 Jul 2014
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Renvert S, Giovannoli JL, Rinke S. The efficacy of reconstructive therapy in the surgical management of peri-implantitis: A 3-year follow-up of a randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1267-1276. doi: 10.1111/jcpe.14049. Epub 2024 Jul 17.
PubMed 39020503Renvert S, Giovannoli JL, Roos-Jansaker AM, Rinke S. Surgical treatment of peri-implantitis with or without a deproteinized bovine bone mineral and a native bilayer collagen membrane: A randomized clinical trial. J Clin Periodontol. 2021 Oct;48(10):1312-1321. doi: 10.1111/jcpe.13513. Epub 2021 Jul 29.
PubMed 34169551
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Peri-implantitis Lesions, With or Without the Placement of a Bone Substitute and a Collagen Membrane. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02375750
- Acronym / sponsor ID
- GS13530231
- Conditions
- Peri-implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Mar 2015 (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 primary objective of the study is to proof the successful use of Geistlich Bio-Oss® and Geistlich Bio-Gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.
Detailed description
Patient who will considered eligible at the screening visit will undergo surgical treatment procedure within 2 weeks. At the day of the surgery the patients will be randomized into the 2 treatment groups.
The subjects will be then prescribed postoperative antibiotics (Azitromax 500 mg day one and 250 mg day 2-4).
Post-operative pain will be controlled with Ibuprofen (400mg x 3) for two days to all subjects. Subjects will rinse twice daily with Chlorhexidine mouth rinse and use modified oral hygiene procedures during the first 5 weeks of healing. Subjects will receive professional prophylaxis as required.
Subjects will be instructed on appropriate oral hygiene throughout the study and will be given appropriate oral hygiene instructions. Instructions on post-operative care will be repeated at each visit. In particular the following points have to be covered during the first month after surgery: Chlorhexidine rinses, avoidance of brushing, usage of interdental cleaning devices, avoidance of chewing on or trauma to the treated area. In addition subjects will be instructed not to smoke more than 10 cigarettes per day during the entire study period and not to consume alcohol during antibiotic therapy.
Sutures will be removed after 14 days. Photos will be taken during the whole study to document the healing process.
Further follow up visits will be scheduled 6 weeks and 3,6,9,12 months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBO and GBG | Experimental | Device: GBO and GBG0.2 g-0,5 g GBO and 1 GBG once after decontamination of implant surface |
| Standard treatment | Active comparator | Other: Standard treatmentDecontamination of surface of implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18 years or older
- Presence of peri-implantitis
- A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
- Clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site.
- During surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present.
Key exclusion criteria (9 listed)
- Subjects with diabetes mellitus (HbA1c > 7.0)
- Subjects taking prednisone or other anti-inflammatory prescription drug
- Subjects taking medications known to have effects on gingival growth
- If the same patient has more than one defect meeting the inclusion criteria, only one such defect will be included in the study
- General contraindications for dental and/or surgical treatments
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 |
|---|---|---|
| GBO and GBGApplication of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant | Device | GBO and GBG |
| Standard treatmentRemoval of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing | Other | Standard treatment |
Primary outcome
Change in the dimensions of the bone defect
Time frame: 6 months, 1 year
4 secondary outcomes
Change in pocket depth
Time frame: 3 months,6months, 9 months,12months
Change in gingival inflammation
Time frame: 3 months,6months, 9 months,12months
Changes in recession of the mucosal margin
Time frame: 3 months,6months, 9 months,12months
Subject satisfaction with the outcome at the study end
Time frame: 12months
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 25 Feb 2019.
- Derived from this study: PubMed 39020503Renvert S, Giovannoli JL, Rinke S. The efficacy of reconstructive therapy in the surgical management of peri-implantitis: A 3-year follow-up of a randomized clinical trial. J Clin Periodontol. 2024 Oct;51(10):1267-1276. doi: 10.1111/jcpe.14049. Epub 2024 Jul 17.
- Derived from this study: PubMed 34169551Renvert S, Giovannoli JL, Roos-Jansaker AM, Rinke S. Surgical treatment of peri-implantitis with or without a deproteinized bovine bone mineral and a native bilayer collagen membrane: A randomized clinical trial. J Clin Periodontol. 2021 Oct;48(10):1312-1321. doi: 10.1111/jcpe.13513. Epub 2021 Jul 29.
- 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.
Stefan Renvert, Professor principal investigator
Department of Health Sciences, Kristianstad 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 GBO and GBG and Standard treatment in people with Peri-implantitis, run by Geistlich Pharma AG 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 8 inclusion and 9 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 25 Feb 2019. 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?
Change in the dimensions of the bone defect (time frame: 6 months, 1 year). 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 NCT02375750, which also lists 2 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 25 Feb 2019.