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Effects of S-PRG Nanoparticles Dispersion on Gum Tissues

Evaluation of the effects of S-PRG Nanoparticle dispersion on periodontal tissues: in vitro analysis of biological interactions and clinical trial in humans - S-PRG Surface Pre-Reacted Glass-ionomer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5j4wkxk
Enrollment
Unknown
Registered
2025-10-13
Start date
2025-11-10
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

Gingivitis

Interventions

This is a randomized, parallel, double-blind controlled clinical trial. Control group: 35 participants with gingivitis using a flavored water-based mouthwash
Positive control group: 35 participants with gingivitis using a mouthwash containing 0.12% chlorhexidine digluconate
Experimental group: 35 participants with gingivitis using a mouthwash containing a dispersion of Surface Pre-Reacted Glass-ionomer nanoparticles. The test and control mouthwashes will be provided to p

Sponsors

Instituto de Ciência e Tecnologia - São José dos Campos - Universidade Estadual Paulista
Lead Sponsor
Instituto de Ciência e Tecnologia - São José dos Campos - Universidade Estadual Paulista
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals with gingivitis presenting a gingival bleeding index equal to or greater than 10%; probing depth equal to or less than 3 mm; aged 18 years or older; in good general health; and willing to participate in the study by signing the informed consent form

Exclusion criteria

Exclusion criteria: Individuals with periodontitis; smokers; pregnant or breastfeeding women; individuals who have used mouthwashes within the past 6 months; those under chronic use of medications that affect periodontal response, such as antibiotics, anti-inflammatory drugs, anticonvulsants, immunosuppressants, or sodium channel blockers within the past 6 months; individuals with systemic conditions such as diabetes, cardiovascular disease, cancer, obesity, rheumatoid arthritis, metabolic syndromes, respiratory diseases, or those requiring antibiotic prophylaxis; and individuals wearing orthodontic appliances

Design outcomes

Primary

MeasureTime frame
To evaluate the reduction of gingival bleeding, determined by probing, through comparison between the groups at baseline and at the end of the study.

Secondary

MeasureTime frame
A reduction in the plaque index, a decrease in microorganisms in the dental plaque samples, and lower cytokine levels in the gingival crevicular fluid are expected to be observed at baseline and at the end of the study

Countries

Brazil

Contacts

Public ContactAndréa De Marco

Instituto de Ciência e Tecnologia de São José dos Campos - UNESP

andrea.marco@unesp.br+55(12)3947-9043

Outcome results

None listed

Source: REBEC (via WHO ICTRP)