Peri-implantitisBony defectsNCT07809334
Implant Survival After Surgical Treatment of Peri-implantitis of Infra-bony Defects
An observational study of Peri-implantitis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
To report the 10 years outcomes of a reconstructive surgical protocol for peri-implantitis defects with different morphologies, by means of deproteinized bovine bone mineral with 10% collagen (DBBMC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- Reconstructive therapy
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 30 Jun 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects rehabilitated with oral dental implants who presented a single peri-implantitis crater-like lesion with a PD of ≥6 mm
Who may be able to join
- Patients rehabilitated with oral dental implants affected by peri-implantitis
- A single peri-implantitis crater-like lesion with a Probing depth ofof ≥6 mm
- No implant mobility,
- Smokers
Who cannot join
- Probing depth <6 mm;
- Class II defects (characterized by consistent horizontal bone loss);
- Multiple defects;
- Implant mobility;
- Subjects not interested in participating in the study;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implant Survival After Reconstructive Surgical Therapy of Peri-implantitis-related Bone Defects With Different Defect Configurations
To report the 10 years outcomes of a reconstructive surgical protocol for peri-implantitis defects with different morphologies, by means of deproteinized bovine bone mineral with 10% collagen (DBBMC).
Read the detailed description
The original population of this case series consisted of 75 patients with one crater-like defect and probing depth (PD) ≥6 mm. After flap elevation, defects were assigned to one characteristic class and treated by means of DBBMC. Following healing, patients were enrolled in an individualized supportive periodontal/ peri-implant (SPT) program.
- Conditions
- Peri-implantitis
- Being tested
- Reconstructive therapy
- Keywords
- Peri-implantitis, Surgical 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.
Reconstructive therapyProcedure or surgery
Intervention: Following the elevation of a muco-periosteal flap, all granulation tissue was completely removed from the defect area, by means of titanium curettes and a titanium brush under irrigation. Consequently, implant surfaces were covered with EDTA 24% for 2 min and chlorhexidine 1% gel for 2 min. Thereafter, the infrabony defects were filled with a deproteinized bovine bone mineral with 10% collagen. All patients were asked to follow an individualized supportive care program.
| Study group | Role | What they receive |
|---|---|---|
| Patients rehabilitated with a dental implants affected by a crater-like defect | Subjects, who presented a single peri-implantitis crater-like lesion with a PD of ≥6 mm and no implant mobility.
Exclusion criteria were as follows:
1. PD <6 mm;
2. Class II defects (characterized by consistent horizontal bone loss);
3. Multiple defects;
4. Implant mobility;
5. No interest in participating in the study;
6. Implants placed by other clinicians. Receives: Procedure: Reconstructive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Clinical Examination: Number of implants treated for peri-implantitis present in the oral cavity at the latest follow-up over the overall number of implants treated, expressed in %
Measured: From enrollment to the end of treatment at the 10-year follow-up visit
Implant survival rate
Percentage of implants still in place after surgical intervention
Measured: 10-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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
- Prospective
- Enrolment
- 75 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809334
- Sponsor's protocol ID
- 00507/2020
- Acronym
- Bony defects
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roccuzzo M, Mirra D, Pittoni D, Ramieri G, Roccuzzo A. Reconstructive treatment of peri-implantitis infrabony defects of various configurations: 5-year survival and success. Clin Oral Implants Res. 2021 Oct;32(10):1209-1217. doi: 10.1111/clr.13818. Epub 2021 Aug 16.
PubMed 34352140
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Survival After Reconstructive Surgical Therapy of Peri-implantitis-related Bone Defects With Different Defect Configurations
- ClinicalTrials.gov ID
- NCT07809334
- Acronym / sponsor ID
- Bony defects / 00507/2020
- Conditions
- Peri-implantitis
- Keywords
- Peri-implantitis, Surgical treatment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Sep 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.
To report the 10 years outcomes of a reconstructive surgical protocol for peri-implantitis defects with different morphologies, by means of deproteinized bovine bone mineral with 10% collagen (DBBMC).
Detailed description
The original population of this case series consisted of 75 patients with one crater-like defect and probing depth (PD) ≥6 mm. After flap elevation, defects were assigned to one characteristic class and treated by means of DBBMC. Following healing, patients were enrolled in an individualized supportive periodontal/ peri-implant (SPT) program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients rehabilitated with a dental implants affected by a crater-like defect | – | Procedure: Reconstructive therapySubjects, who presented a single peri-implantitis crater-like lesion with a PD of ≥6 mm and no implant mobility. Exclusion criteria were as follows: 1. PD <6 mm; 2. Class II defects (characterized by consistent horizontal bone loss); 3. Multiple defects; 4. Implant mobility; 5. No interest in participating in the study; 6. Implants placed by other clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects rehabilitated with oral dental implants who presented a single peri-implantitis crater-like lesion with a PD of ≥6 mm
Key inclusion criteria (4 listed)
- Patients rehabilitated with oral dental implants affected by peri-implantitis
- A single peri-implantitis crater-like lesion with a Probing depth ofof ≥6 mm
- No implant mobility,
- Smokers
Key exclusion criteria (5 listed)
- Probing depth <6 mm;
- Class II defects (characterized by consistent horizontal bone loss);
- Multiple defects;
- Implant mobility;
- Subjects not interested in participating in the study;
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 |
|---|---|---|
| Reconstructive therapyIntervention: Following the elevation of a muco-periosteal flap, all granulation tissue was completely removed from the defect area, by means of titanium curettes and a titanium brush under irrigation. Consequently, implant surfaces were covered with EDTA 24% for 2 min and chlorhexidine 1% gel for 2 min. Thereafter, the infrabony defects were filled with a deproteinized bovine bone mineral with 10% collagen. All patients were asked to follow an individualized supportive care program. | Procedure or surgery | Patients rehabilitated with a dental implants affected by a crater-like defect |
Primary outcome
Implant survival rate
Time frame: From enrollment to the end of treatment at the 10-year follow-up visit
Clinical Examination: Number of implants treated for peri-implantitis present in the oral cavity at the latest follow-up over the overall number of implants treated, expressed in %
Implant survival rate
Time frame: 10-year
Percentage of implants still in place after surgical intervention
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 9 Sep 2026.
- Results publication: PubMed 34352140Roccuzzo M, Mirra D, Pittoni D, Ramieri G, Roccuzzo A. Reconstructive treatment of peri-implantitis infrabony defects of various configurations: 5-year survival and success. Clin Oral Implants Res. 2021 Oct;32(10):1209-1217. doi: 10.1111/clr.13818. Epub 2021 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Turin, Italy at 1 site in Italy.
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 4 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 9 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 Italy. 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?
Implant survival rate (time frame: From enrollment to the end of treatment at the 10-year follow-up visit). The study lists 2 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 NCT07809334, 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 9 Sep 2026.