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Laboratory and clinical study of implants of reduced diameter

Biomechanical behavior of ultra-narrow diameter implants - NDI : Narrow dental implants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5gf7kx
Enrollment
Unknown
Registered
2018-12-27
Start date
2017-06-07
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

Xenarthra

Interventions

To evaluate the survival of ultra-narrow implants (clinical and radiographic evaluation). Total edentulous patients and patients with unit losses in areas with low masticatory effort (n = 20) after th
Procedure/surgery
D25.339.312

Sponsors

Faculdade de Odontologia da Universidade Federal de Uberlândia
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Uberlândia
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Good systemic health or clinically compensated (proven by means of medical certificate) that allows surgical procedures. Conditions whose reports or signs should be absent during anamnesis and clinical examination include uncontrolled diabetes mellitus and severe cardiovascular disease; Accept the stabilization of their total superior dentures by means of two implants, after clarifying the information during the initial consultation (Over Group); Patients with absence of one or more elements in areas of low occlusal load (upper lateral incisors and lower incisors) for the Uni Group; Present adequate space in the anterior maxilla for the installation of 2 narrow implants, without the need of grafting, evaluated by clinical and radiographic examination (Over Group) and adequate space in the maxilla or mandible for the installation of 1 or more unit implants ( Uni Group); be able to maintain adequate oral hygiene and sanitize their prostheses; Free edge of pathologies in soft tissue and bone; Adequately understand Portuguese, both spoken and written; be able to provide free and informed consent.

Exclusion criteria

Exclusion criteria: Pathological alterations of the alveolar borders; Acute or chronic symptoms of disorders due to parafunction; History of radiotherapy in the orofacial region; Specific conditions such as alcoholism, smoking (a maximum limited number of 10 cigarettes / day was accepted); Cognitive motor disorders; debilitating / severe systemic diseases requiring frequent hospitalization; Patients who do not fit into any standard of inclusion criteria.

Design outcomes

Primary

MeasureTime frame
The outcome variables will be evaluated at the time of implant installation (Baseline) and then at 6,12, 18 and 36 months after implant installation. The data will be collected through standardized forms containing items related to clinical observations and bone loss will also be evaluated by means of standardized periapical radiographs and measurement of depth of sounding.

Secondary

MeasureTime frame
Among the several outcome variables, the clinical situation of the prosthesis will be initially reported for both groups (presence or absence of complications in the prosthetic restoration). The evaluation of the occlusal situation of the patient and the condition of the prosthesis in this environment should be made. ;Problems related to prosthesis and implant, as well as peri-implant tissue condition and TMJ pain symptomatology will be described when identified at clinical examination. A personalized follow-up clinical form will be used. ;In addition, a depth survey will be performed around the 4-sided implants (mesial, distal, buccal and lingual) using a periodontal probe measured at all follow-up times (6, 12, 18 and 36 months). ;In the moments of evaluation will be filled a specific form of success of the overdentures and implants in which the female and male attachments, implant situation, overdenture and antagonist will be evaluated. Also, the presence of pain and difficulty to insert or remove the prosthesis will be described. ; Participants in the survey will also respond to the OHIP and Sats-P Questionnaires regarding oral health-related quality of life and patient satisfaction regarding aesthetics, retention and comfort with the prostheses respectively.

Countries

Brazil

Contacts

Public ContactFLAVIO DOMINGUES NEVES

Faculdade de Odontologia da Universidade Federal de Uberlândia

flaviodominguesneves@gmail.com+55 034 3218-2222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)