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Clinical trial for evaluation of the anti-plaque effect and gingival inflammation of a mouthwash containing chlorhexidine tetrapalmitate

Development of mouthwash containing chlorhexidine tetrapalmitate and clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6347fv
Enrollment
Unknown
Registered
2019-06-11
Start date
2018-10-01
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

Periodontal disease, unspecified

Interventions

Clinical, cross-over, two-armed, double-blind, randomized controlled trial on the evaluation of the action of chlorhexidine tetrapalmitate compared to chlorhexidine digluconate in bacterial plaque and
Other
V03.175.250

Sponsors

Universidade Estadual Paulista (Unesp), Faculdade de Ciências Farmacêuticas, Araraquara
Lead Sponsor
Universidade Estadual Paulista (Unesp), Faculdade de Ciências Farmacêuticas, Araraquara
Collaborator

Eligibility

Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: To present a proven diagnosis of gingivitis; Presence of plaque in 30% or more of the sites; Presence of at least 5 teeth in each hemi-arch; A negative history of antibiotic use in the last six months before the study; A negative history of steroid or non-steroidal anti-inflammatory drugs in the last three months prior to or during the study.

Exclusion criteria

Exclusion criteria: Received periodontal treatment in the last 12 months; To present a systemic condition that interferes in the health-disease process; Be pregnant or breastfeeding; Be smoker; Present allergy to chlorhexidine; To present partial removable prosthesis or fixed prosthesis / maladaptive restorations; No attendance for sample withdrawal, form filling and periodontal evaluations.

Design outcomes

Primary

MeasureTime frame
To find significant differences in the use of chlorhexidine mouthrinse containing 0.3% tetrapalmitate (TPCHX) when compared to standard chlorhexidine (CHX) in the same period and frequency, with lower adverse effects and with a desirable therapeutic effect.

Secondary

MeasureTime frame
Clinical evaluation of the primary outcome through: Change / decrease of bacterial plaque production and gingivitis in relation to grades of gingival index (GI); plaque index (PI); measurements of depth of probing and level of clinical insertion; and presence (+) or absence (-) for bleeding at probing using periodontal probe.

Countries

Brazil

Contacts

Public ContactCarla Ribeiro Ferreira

Universidade Estadual Paulista (Unesp), Faculdade de Ciências Farmacêuticas, Araraquara

carla.ferreira@unesp.br+55 16 3301-6962

Outcome results

None listed

Source: REBEC (via WHO ICTRP)