Skip to content

Effect of the type of loading of mandibular overdentures retained by narrow diameter implants produced by additive manufacturing: randomized clinical trial

Effect of the type of loading of mandibular overdentures retained by narrow diameter implants produced by additive manufacturing: randomized clinical trial to analyze the clinical, immuno-inflammatory, functional impact and quality of life indicators

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9d94bxv
Enrollment
Unknown
Registered
2024-06-21
Start date
2023-10-11
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

Atrophy of the alveolar residual ridge

Interventions

This is a randomized clinical trial of equivalence and parallel groups and blind (evaluator). Randomization by type of treatment will be carried out using the patient unit as a base, the randomization

Sponsors

Faculdade de Odontologia da Universidade Federal de Pelotas/RS
Lead Sponsor
M3 Health Industria e Comercio de Produtos Medicos, Odontologicos e Correlatos S.a.
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both sexes; in a balanced number without age criteria; no self reported systemic health problems; do not use any medication in the last 3 months that affects the immune response; bone quality without the need for local bone grafting; availability to attend Faculty of Dentistry at the Federal University of Pelotas

Exclusion criteria

Exclusion criteria: Patients who smoke; severe diabetes; blood disorders; hemorrhagic diastasis; drug-induced anticoagulation; rheumatoid arthritis; osteogenesis imperfecta; HIV; use of immunosuppressive medications; history of radiotherapy to the head or neck region, history of previous oral implant insertion; patients who have undergone treatment with bisphosphonates in the last 12 months; if female, not pregnant or lactating; with constant use or with a medical history marked by chronic use of analgesics; anti-inflammatories and psychotropic drugs; need for bone grafting at the implant site

Design outcomes

Primary

MeasureTime frame
Assessment of the release of cytokines (IL-1ß, IL-6, IL-10, IL-17, TNF-a) during the implant healing phase and 6 months after the installation of overdentures.

Secondary

MeasureTime frame
Monitoring of clinical parameters through examinations of visible plaque index, gingival bleeding index, presence of calculus, probing depth index and implant stability quotient.;Evaluate quality of life and chewing function indicators before loading, during the first year of transition from complete dentures to overdentures and after 2 and 3 years.;Monitor the peri-implant bone level and posterior resorption of the mandibular ridge after 1, 2 and 3 years of occlusal loading.;Monitor the circumferential bone level of the implants at 1 and 3 years.;Evaluate the success and survival of implants.;Describe prosthetic complications over 3 years depending on.

Countries

Brazil

Contacts

Public ContactLucas da Silva

Faculdade de Odontologia da Universidade Federal de Pelotas/RS

contato.lucassilva12@gmail.com+55(53)991879549

Outcome results

None listed

Source: REBEC (via WHO ICTRP)