NCT07809334

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

August 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

August 24, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Peri-implantitisSurgical treatment

Outcome Measures

Primary Outcomes (2)

  • 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 %

    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

    10-year

Study Arms (1)

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.

Procedure: Reconstructive therapy

Interventions

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.

Patients rehabilitated with a dental implants affected by a crater-like defect

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects rehabilitated with oral dental implants who presented a single peri-implantitis crater-like lesion with a PD of ≥6 mm

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.C. Chirurgia Maxillo-facciale U

Torino, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations