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Evaluation of a Rapid Salivary Test in Patients with Periodontitis with and without Sistemic Diseases

Evaluation of a Rapid Test for Total Saliva Protein in Periodontal Patients with and without Comorbidities

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2qbpczv
Enrollment
Unknown
Registered
2023-02-23
Start date
2021-07-20
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

Diabetes Mellitus

Interventions

This is an interventionist, experimental, quantitative and prospective study on the development of a diagnostic kit for salivary testing, with the aim of evaluating active periodontal disease, taking
or diagnosed with Periodontitis Stages 2 or 3 and Grade C aged between 18 and 35 years and having 8 teeth with 5mm PS and 3mm insertion loss, without direct relation to clinically detectable etiologic

Sponsors

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

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Minimum of 14 natural teeth (at least 10 posterior); periodontitis diagnosis; Systemically healthy patients; patients diagnosed with diabetes or rheumatoid artrhitis

Exclusion criteria

Exclusion criteria: Smoking, pregnancy; total edentulism; recent periodontal treatment; recent use of antibiotics; patients who refused to sign the Consent Form

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: When comparing total protein levels between the study groups, it is expected that concentrations in groups without periodontal disease will be lower than in groups with periodontitis. It is also expected that there will be a reduction in total protein levels after periodontal treatment in all groups.;Outcome found 1: It was observed that the total protein concentrations in the groups without periodontitis were lower than in the groups with periodontitis, and the groups without systemic involvement had lower concentrations of total protein when compared to the groups with diabetes and rheumatoid arthritis. In addition, it was observed that there was a reduction in total protein concentration values ??(µg/mL) between baseline and 45 days in the periodontitis, Diabetes with periodontal health, Diabetes with periodontitis and Arthritis with periodontitis groups, however, this difference was significant only in the periodontitis group, while there was an increase in total protein concentration in the control and Arthritis with periodontal health groups, but this increase was not statistically significant.

Secondary

MeasureTime frame
Expected outcome 2: After periodontal treatment, it is expected that there will be an improvement in the clinical parameters evaluated in all groups and that this improvement will be detectable in the diagnostic test, proving its effectiveness.;Outcome found 2: It was observed that, in the plaque index, there was a reduction in the percentage of plaque in most groups (control, periodontitis, arthritis with periodontitis, diabetes with periodontal health and diabetes with periodontitis), this improvement being statistically significant only in the control, periodontitis and arthritis with periodontitis, while the arthritis with periodontal health group had worsening, but not significantly. In the bleeding index, it was observed that all groups had improvement in the percentage of marginal bleeding, however, in no group was this difference significant. In the probing depth, there was improvement in the periodontitis, arthritis with periodontitis and arthritis with periodontitis groups, but there was only a significant difference in the periodontitis and arthritis with periodontitis groups, while the control groups, diabetes with periodontitis and diabetes with periodontal health showed worsening, but that was not significant. In bleeding on probing, there was improvement in the control, periodontitis, diabetes with periodontal health, diabetes with periodontitis and arthritis with periodontitis groups, but this change was statistically significant only in the periodontitis group, while there was a worsening in the arthritis with periodontal health group, but without statistical significance. Regarding the salivary test, there was an improvement in the periodontitis, diabetes with periodontitis, arthritis with periodontal health and arthritis with periodontitis groups, while there was a worsening in the control and diabetes with periodontal health groups, however, this difference was not significant. On the other hand, visually, it could be observed that there was a ch

Countries

Brazil

Contacts

Public ContactNathalya Moura

Universidade de São Paulo, Faculdade de Odontologia de Ribeirão Preto

nathalya_vilela@usp.br+55(16)3315-3000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)