FindTrial
Sign In

Long-term clinical outcome after reconstruction of atrophied alveolar ridge using collagenated xenogeneic bone block (CXBB) or autogenous bone block (ABB). Follow-up of randomized controlled clinical investigation 10828-021.

Long-term clinical outcome after reconstruction of atrophied alveolar ridge using collagenated xenogeneic bone block (CXBB) or autogenous bone block (ABB). Follow-up of randomized controlled clinical investigation 10828-021.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00017137
Enrollment
64
Registered
2019-05-29
Start date
2020-03-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Survival of the implants as well as the bone tissue and soft tissue at the augmented area

Interventions

Group 1: Control treatment for reconstruction of atrophied alveolar ridge with autologous bone block (ABB) Group 2: Test treatment for reconstruction of atrophied alveolar ridge with collagenated xeno

Sponsors

Geistlich Pharma AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Successful atrophied alveolar ridge reconstruction in clinical investigation 10828-021 - Implant placement at restored site - Implant loading - Written informed consent - Final impression taken at the delivery of the implant-supported restoration (Visit 10 in study No. 10828-021) (Amendment No.1)

Exclusion criteria

Exclusion criteria: - Newly diagnosed diseases interfering with bone metabolism - Severe trauma to implant site - Orthodontic treatment in the same quadrant - Participation in a clinical study interfering with the objective of this non-interventional long-term follow-up observation

Design outcomes

Primary

MeasureTime frame
- Assessment of implant presence in the mouth at 1, 2, 3, 4, and 5 years after implant placement (V6) in clinical investigation 10828-021.—

Secondary

MeasureTime frame
- Peri-implant clinical parameters will be determined by a periodontal probe at 1, 2, 3, 4, and 5 years after implant placement (V6) in clinical investigation 10828-021 - Marginal Bone Resorption will be measured - Tissue volumetric changes will be evaluated - Surgeon’s esthetic assessment - Subject’s questionnaire on Oral Health-Related Quality of Life - Assessment of subject’s outcome satisfaction (VAS) - Implant success evaluation—

Countries

Brazil

Contacts

Public ContactElena Mancini

Clinical Affairs

elena.mancini@geistlich.ch+41 41 492 68 40

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026