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Study of two different devices for bone augmentation

Barbell technique versus titanium reinforced PTFE membranes for bidirectional bone augmentation: multi-centre randomized clinical trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9jw6tnm
Enrollment
Unknown
Registered
2024-12-20
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Alveolar Bone Loss

Interventions

This is a 2-arm, double-blind, multi-centre randomized clinical study. Sites requiring horizontal reconstruction will be enrolled in the study. In PTFE Group (PTFEG, n=29), an anorganic xenograft cove

Sponsors

Centro de Pesquisas Odontológicas São Leopoldo Mandic SS
Lead Sponsor
Centro de Pesquisas Odontológicas São Leopoldo Mandic SS
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients should have 18 years or older; signed inform consent; partial edentulism (up to 4 adjacent missing teeth); atrophied alveolar ridge with one or more adjacent missing teeth; atrophied alveolar ridge with residual remaining thickness less than 4mm; sufficient bone height at the surgical site to install implant

Exclusion criteria

Exclusion criteria: Patients with periodontal or peri-implant diseases; general contraindications for surgical procedures; inflammatory process / disease of oral cavity; dental implants adjacent to the surgical site; known or suspected non-compliance, drug or alcohol abuse; smokers or subjects who did not quit smoking at least 3 months before the surgery; diabetes; previous, concurrent or planned radiation therapy for head or neck cancer; concurrent or previous immunosuppressant, bisphosphonate, high-dose or long-term corticosteroid therapy; pregnant or lactating women; women of childbearing age, who are not using a highly effective method of birth control; participants in an investigational device, drug or biological study within the last 26 weeks prior to study start; participants in any other clinical investigation during the study

Design outcomes

Primary

MeasureTime frame
It's expected to find absence of difference in the bone gain, verified by computed tomographic scan, using a comparative statistical analysis, for horizontal bone augmentation

Secondary

MeasureTime frame
It's expected to verify a lower occurrence of soft tissue dehiscence and a lower level of the duration of surgery at Barbell Technique Group (BTG), when compared with the PTFE Group (PTFEG)

Countries

Brazil, United States

Contacts

Public ContactMarcelo Napimoga

Faculdade São Leopoldo Mandic

marcelo.napimoga@slmandic.edu.br+55-19-981116661

Outcome results

None listed

Source: REBEC (via WHO ICTRP)