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Evaluation of the clinical effectiveness of treating moderate and severe periodontitis with S-PRG particle solution: a randomized controlled clinical trial

Clinical efficacy of Full-mouth Scaling associated with S-PRG particles solution for the Non-surgical Treatment of stage III and IV Periodontitis: A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7k87ynr
Enrollment
Unknown
Registered
2023-08-02
Start date
2023-08-04
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 two-arm double blind randomized controlled clinical trial. Randomization will be done using the sealed envelope software by a person who is not part of the study team. The masking will be fo
E06.721.189.350

Sponsors

Instituto de Ciência e Tecnologia de São José Dos Campos ICTSJC - Universidade Estadual Paulista UNESP
Lead Sponsor
Instituto de Ciência e Tecnologia de São José Dos Campos ICTSJC - Universidade Estadual Paulista UNESP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Stage III and IV periodontitis; at least 6 sites with probing depths greater than or equal to 6 mm in at least 2 multirooted teeth or 2 single-radicular teeth in at least one quadrant; radiographic bone loss extending from the middle to the apical third of the roots; at least 18 teeth; over 18 years of age; in good general health; agree to participate in the study by signing a consent form

Exclusion criteria

Exclusion criteria: Smokers; Pregnant or lactating women; Patients who have received periodontal treatment within the past 6 months; Chronic use of drugs that affect the periodontal response such as antibiotics, anti-inflammatory drugs, anticonvulsants, immunosuppressants and sodium channel blockers within 6 months; Systemic diseases such as diabetes, cardiovascular disease, cancer, obesity, rheumatoid arthritis, metabolic syndromes, respiratory diseases or need for antibiotic prophylaxis; Patients who have braces; History of sensitivity to chlorhexidine

Design outcomes

Primary

MeasureTime frame
It is expected to find an improvement in the clinical parameters evaluated (plaque index, bleeding index, probing depth, clinical attachment level, and periodontal pocket closure).

Secondary

MeasureTime frame
The patient's quality of life is expected to improve, and will be assessed using the OHIP 14 questionnaire at baseline, and at 3 and 6 month follow-up.

Countries

Brazil

Contacts

Public ContactClarissa Maciel

Instituto de Ciência e Tecnologia de São José dos Campos/ICTSJC/UNESP

clarissa.maciel@unesp.br+55-12-39479043

Outcome results

None listed

Source: REBEC (via WHO ICTRP)