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Clinical study of Removable Partial Dentures constructed with different structural materials

Removable Partial Dentures with Co-Cr versus PEEK structure: clinical crossover study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4ccdqh6
Enrollment
Unknown
Registered
2023-07-31
Start date
2022-01-01
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

Jaw, Edentulous

Interventions

This is a uni-blind cross-sectional clinical study with 10 participants. In the first stage the volunteers will be selected and evaluated regarding the variables, using the old prostheses. Then, the v

Sponsors

Faculdade de Odontologia de Piracicaba - FOP/UNICAMP
Lead Sponsor
Universidade Estadual de Campinas - UNICAMP
Collaborator

Eligibility

Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Present good general health status or presence of systemic diseases (such as hypertension and/or diabetes) that are properly controlled; age between 40-65 years; total upper and lower partial edentulousness (Kennedy Class I), with unsatisfactory CDs and RPDs according to Vigild's criteria (Vigild et al., 1987); having the shape of the lower alveolar ridges classified as horizontal or distal ascending (in the mesiodistal direction), and normal or high (in the buccolingual direction), according to the American College of Prosthodontics (McGarry et al. 1999), evaluated by means of the clinical examination and normal salivary flow (= 0.6 ml/min)

Exclusion criteria

Exclusion criteria: Individuals with painful symptomatology of the temporomandibular joints and/or mastication muscles; uncontrolled systemics diseases; xerostomia patients; severe periodontal disease and/or tooth mobility

Design outcomes

Primary

MeasureTime frame
Adaptation - It is expected to find better adaptation to the supporting tissues of the removable partial denture in the experimental group (with Peek) in relation to the control group (Cr-Co alloy) during the evaluation period. The evaluation will be carried out clinically, using the replica technique.;Masticatory performance and efficiency - It is expected to find increased performance and masticatory efficiency in the experimental group compared to the control group during the evaluation period. It will be evaluated through the sieve system, and calculated using the Rosin-Rammler equation (obtaining X50 and b).;Maximum bite force - It is expected to find an increase in the maximum bite force of the experimental group compared to the control group during the evaluation period. It will be evaluated through a force transducer composed of pressure sensors and registered in Kilogram-force (Kgf), and later, transformed into Newton (N).;Diet - It is expected to find improvements in the food quality of the volunteers of the experimental group compared to the control group during the evaluation period. They will be evaluated through a food diary for 3 days and the nutritional status of the volunteers will be established after tabulating the food data in free software (Dietbox®), with reference to the Brazilian Food Composition Table (NEPA).;Patient satisfaction with prosthetic treatment - It is expected to find an improvement in the satisfaction of the volunteers in the experimental group compared to the control group during the evaluation period. It will be evaluated using the Visual Analogue Scale (VAS) of 100 mm, where the patient must indicate the satisfaction about stability, comfort, ability to chew, ability to speak, ease of cleaning and aesthetic appearance. The level of satisfaction can be ranging from “completely dissatisfied” and “completely satisfied”, and the average value must be obtained at from the sum of the seven questions.

Secondary

MeasureTime frame
No secondary outcomes expected

Countries

Brazil

Contacts

Public ContactPedro Henrique De Oliveira

Faculdade de Odontologia de Piracicaba - FOP/UNICAMP

p235414@dac.unicamp.br+55 (19) 21065294

Outcome results

None listed

Source: REBEC (via WHO ICTRP)