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Complete Dentures Obtained by Three-Dimensional Printing Compared to the Conventional Technique – Clinical, Crossover, Randomized and Controlled Study

Complete Dentures obtained by Additive Manufacturing compared to Conventional Manufacturing – Clinical crossover, randomized and controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-293yfsj
Enrollment
Unknown
Registered
2025-06-16
Start date
2024-09-19
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

Jaw, Edentulous

Interventions

This is a randomized, controlled, crossover clinical study, consisting of a single group of 26 participants, so that each one will use, in a crossover and performed manner, a pair of total dentures ob

Sponsors

Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals aged 45 years or older; of both genders; completely edentulous for at least 1 year; mentally receptive; with good understanding of spoken Portuguese; with normal unstimulated saliva flow (0.3 mL/min); without Denture-Related Stomatitis; presenting satisfactory or good ridges, according to the Kapur Index

Exclusion criteria

Exclusion criteria: Individuals with disorders of the stomatognathic system; with pathological alterations of the ridges or seat tissues of the prostheses; debilitating systemic conditions such as Decompensated Diabetes Mellitus, Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease, Heart Failure, Advanced Liver Disease and malignant tumors; autoimmune diseases such as Systemic Lupus Erythematosus or Multiple Sclerosis; HIV/AIDS and malnutrition; self-reported pain; motor and cognitive disorders; use of antibiotics in the 3 weeks prior to recruitment

Design outcomes

Primary

MeasureTime frame
To assess the quality of prostheses in terms of resting interocclusal distance (RID), occlusion, articulation, retention of the maxillary prosthesis and stability of the maxillary and mandibular prostheses. The quality of printed prostheses is expected to be equal to or greater than the quality of conventional prostheses.;To evaluate the effect of hygiene protocols on biofilm control (prevalence of microorganisms, microbial load, biofilm removal, cellular metabolism and formation of hyphae or pseudohyphae of Candida spp.). It is expected that the two hygiene protocols will be similarly effective in controlling biofilm, regardless of the type of prosthesis.;To evaluate the effect of hygiene protocols on color changes in prostheses. It is expected that the two hygiene protocols will present similar results regarding color changes, regardless of the type of prosthesis.;Assess the bite force using a gnathometer. The bite force with printed dentures is expected to be equal to or greater than the bite force with conventional dentures.;To evaluate masticatory efficiency using the colorimetric method and chewing gum. It is expected that masticatory efficiency with printed prostheses will be equal to or greater than masticatory efficiency with conventional prostheses.;To assess the activity of the masseter and temporal muscles using surface electromyography. It is expected that muscle activity with printed prostheses will be equal to or greater than muscle activity with conventional prostheses.;To assess aesthetic changes using stereophotogrammetry. It is expected that the facial aesthetic changes promoted by printed prostheses will be equal to or greater than the facial aesthetic changes promoted by conventional prostheses.;To assess the quality of life of participants using the Oral Health Impact Profile (OHIP-Edent) questionnaire. It is expected that the quality of life promoted by printed prostheses will be equal to or greater than the quality of life promoted by convent

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactBeatriz de Camargo Poker

Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo

beatrizpoker@usp.br+55(19)981163006

Outcome results

None listed

Source: REBEC (via WHO ICTRP)