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Clinical Performance of Complete Crowns in Printed Resins obtained by Digital Flow in dentistry

Performance of Full Crowns in Printed Resins obtained by CAD/CAM System. Clinical, controlled, triple blind and randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8hmqbmf
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-06
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

Dental Occlusion

Interventions

Prospective randomized clinical trial, triple blind (patient, operator and examiner). Method of data analysis: The data evaluated against the primary and secondary outcomes will be analyzed regarding
significance level of alfa = 0.05
test power of 80%
expected 5-year survival rate of 92%, and sample loss of 20% the sample calculation was set at n = 40 per group, totaling 80 teeth. Patients will sign an informed consent form – TCLE before starting t
H02.403.720

Sponsors

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

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older; both genders; in need of a single crown in a posterior tooth(s) with major coronary destruction; that the tooth has pulp vitality or satisfactory endodontic treatment; with or without intraradicular retainer; that has a medical history that does not compromise the evolution of the results; that has the habit of brushing the teeth at least once a day; that has normal periodontal condition front to probing parameters; has occlusal stability

Exclusion criteria

Exclusion criteria: Patients younger than 18 years old; with some chronic disease with oral manifestations; who present some oral pathology considered serious; with signs and/or symptoms of parafunction (clenching and/or bruxism); with no oral hygiene; with periodontal disease; with allergies to any material that will be used in the study; smokers; or any other condition that may indirectly interfere with the primary and/or secondary outcomes

Design outcomes

Primary

MeasureTime frame
Want to evaluate the color change and marginal pigmentation of printed crowns cemented on teeth (primary outcome) This clinical study is expected to verify whether different brands used to obtain complete crowns in CAD/CAM system by 3D printing have the same clinical performance and satisfaction , using modified USPSH criteria to assess the longevity of restorations, assess patient satisfaction with rehabilitation using the EVA scale, as well as operator satisfaction with rehabilitation. The assessment of survival of restorations in a minimum period of 5 years. The follow-up will be carried out in 7 moments: immediate (T0), 6 months (T1), 1 year (T2), 2 (T3), 3 (T4), 4 (T5) and 5 years (T6). The data obtained from the primary outcomes will be statistically analyzed for normal distribution and homoscedacity, and then an appropriate statistical test will be used to analyze the outcomes as a function of the evaluation periods (alfa = 0.05)

Secondary

MeasureTime frame
Want to evaluate the dental fracture of the remnants where the impression crowns were cemented It is expected in this clinical study to verify whether different brands used to obtain full crowns in CAD/CAM system by 3D printing have the same clinical performance and satisfaction, using the modified USPSH criteria to evaluate the longevity of restorations, patient satisfaction in relation to rehabilitation using the EVA scale, as well as the operator's satisfaction with the rehabilitation. The evaluation of the survival of the restorations in a minimum period of 5 years. The follow-up will be carried out in 5 moments: 2 years (T3), 3 years (T4), 4 (T5) and 5 years (T6). The data obtained from secondary outcomes will be statistically analyzed for normal distribution and homoscedacity, and then an adequate statistical test will be used to analyze the outcomes as a function of the evaluation periods (alfa = 0.05);Want to evaluate the color change of the cement-retained restoration It is expected in this clinical study to verify whether different brands used to obtain full crowns in CAD/CAM system by 3D printing have the same clinical performance and satisfaction, using the modified USPSH criteria to evaluate the longevity of restorations, patient satisfaction in relation to rehabilitation using the EVA scale, as well as the operator's satisfaction with the rehabilitation. The evaluation of the survival of the restorations in a minimum period of 5 years. The follow-up will be carried out in 5 moments: 2 years (T3), 3 years (T4), 4 (T5) and 5 years (T6). The data obtained from secondary outcomes will be statistically analyzed for normal distribution and homoscedacity, and then an adequate statistical test will be used to analyze the outcomes as a function of the evaluation periods (alfa = 0.05);Want to evaluate the gingival inflammation of the dental remnant that received the printed crown It is expected in this clinical study to verify whether different brands used

Countries

Brazil

Contacts

Public ContactFlávio Neves

Faculdade de Odontolologia da Universidade Federal de Uberlândia

nevesfd@ufu.br+55 (34) 3218-2222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)