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Impact of macro-geometry on the initial bone repair process and primary stability of dental implants

Impact of macro-geometry on the initial bone repair process and primary stability of dental implants: A prospective, controlled, randomized, split-mouth clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-63jtrzs
Enrollment
Unknown
Registered
2025-11-03
Start date
2019-02-04
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Dental Implants

Interventions

This is a randomized, prospective, controlled, double-blind, split-mouth clinical trial in which 20 adult patients of both sexes with total edentulism of the mandible and/or maxilla and sufficient bon
primary stability
and immunoenzymatic evaluation of biomarkers related to vasculo/osteoblast/clastogenesis (OPG, OC, OPN, TNF-a, IL-1ß, IL-6, DKK1, Sclerotin, IL-8/CXCL8, VEGF-A, BMP-9, PLGF, Endothelin-1, EGF and FGF,

Sponsors

Associação Unificada Paulista de Ensino Renovado Objetivo
Lead Sponsor
Universidade Paulista
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patient aged between 18 and 75 years, of both sexs, with total edentulism of the mandible and/or maxilla; patients with sufficient bone volume and height for implant placement

Exclusion criteria

Exclusion criteria: Use of antibiotics; continuous-use anti-inflammatories; phenytoin; cyclosporine; bisphosphonates in the 6 months prior to the study; presence of systemic changes or active infectious disease (diabetes, heart disease, hepatitis, etc.); smoking; pregnancy; breastfeeding

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It is expected to quantitatively evaluate, through the Luminex/MAGpix platform, the concentration of vascular/osteoblast/clastogenic mediators/markers (VEGF-A, PLGF, endothelin-1, DKK1, OC, OPN, OPG, sclerotin, BMP-9, EGF, FGF, Periostin, TRAP5, TWEAK, osteonectin, IL-1ß, IL-6, TNF-a, RANKL) in the peri-implant fluid of the inserted implants;Outcome found 1: It was observed that TNF-a levels were significantly lower in the test group (P<0.05), with no statistically significant differences for the other markers analyzed (P>0.05)

Secondary

MeasureTime frame
Expected outcome 2: It is expected to evaluate the insertion torque at the time of surgery and the primary stability quotient levels of dental implants with modified macrogeometry, after implant placement, and after 45 and 90 days, in comparison with conventional implants;Outcome found 2: It was observed that the insertion torque was significantly lower in the test group (P<0.05). The results demonstrated no significant difference in primary stability between the groups (P>0.05)

Countries

Brazil

Contacts

Public ContactRaissa Machado

Universidade Paulista

raissa.machado3@docente.unip.br+55 (11) 55864093

Outcome results

None listed

Source: REBEC (via WHO ICTRP)