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Effect of local application of Chalcone T4 associated with conventional treatment of Periodontitis: Randomized clinical study

Effect of local application of Chalcone T4 in the adjunctive treatment of Periodontitis: Randomized clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-27sysfx
Enrollment
Unknown
Registered
2025-02-17
Start date
2024-07-01
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

Periodontitis

Interventions

This is a randomized, double-blind, split-mouth clinical study. Twenty patients who meet the eligibility criteria will be selected. Both the researchers who will evaluate the outcomes and the particip
D27.505.696.477.396

Sponsors

Faculdade de Odontologia da Universidade Estadual Paulista Julio de Mesquita Filho Campus Araraquara
Lead Sponsor
Centro Universitário Central Paulista
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy volunteers; both genders; over 18 years old; non-smokers; with the presence of stage III grade A periodontitis, in at least two sites in two different quadrants; with a probing depth greater than or equal to five millimeters; active periodontal disease, verified by the presence of bleeding on probing; have at least fifteen remaining teeth

Exclusion criteria

Exclusion criteria: Volunteers with systemic diseases that contraindicate periodontal treatment, which require antibiotic prophylaxis or use of medications that interfere with the evolution of periodontal disease and/or the results of treatment; pregnant or lactating women; volunteers who smoke or who stopped the habit less than 5 years ago; having used antimicrobials in the last three months; having used steroid or non-steroidal anti-inflammatory medications continuously for more than 7 days in the last 3 months; having received periodontal treatment in the last year; have fewer than 15 teeth present

Design outcomes

Primary

MeasureTime frame
It is expected to find a difference in the average Probing Depth (PS) index 30, 90 and 180 days after periodontal treatment. The measurement of the Probing Depth index will be made with a North Carolina periodontal probe (PUNC # 15, Hu-Friedy) in six sites on each tooth , however, the comparative analysis between the groups will be based on the evaluation of the selected sites. The data obtained will be recorded in a standardized clinical form

Secondary

MeasureTime frame
It is expected to find differences in the microbiological data. The identification of microorganisms present in the subgingival biofilm of the selected sites will be carried out using the Checkerboard DNA-DNA hybridization technique.;It is expected to find variations in the following periodontal clinical indices at the end of six months: Bleeding on probing (SS), clinical attachment level (CIN) and gingival recession (GR). The measurement of the indices will be done with a North Carolina periodontal probe (PUNC # 15, Hu-Friedy) in six sites on each tooth , however, the comparative analysis between the groups will be based on the evaluation of the selected sites.The data obtained will be recorded in a standardized clinical form;It is expected to find variations in the concentration of inflammatory cytokines. Aliquots of each sample of gingival crevicular fluid from the select sites will be examined using the ELISA (Enzyme Immunosorbent Assay) test

Countries

Brazil

Contacts

Public ContactMorgana Guimarães Stabili

Faculdade de Odontologia da Universidade Estadual Paulista Julio de Mesquita Filho Campus Araraquara

morgana.guimaraes@unesp.br+55(16)33016300

Outcome results

None listed

Source: REBEC (via WHO ICTRP)