Comparative study of the effectiveness of two mouthwashes in reducing gingival inflammation in hospitalized patients

Comparative study of the efficacy of Chlorexidine and Chloramine T in Gingivitis reduction in patients admitted to a referral hospital in Ceará

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-8x7534h

Enrollment

Unknown

Registered

2023-12-19

Start date

2023-07-07

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

A randomized, prospective, double-blind, placebo-controlled, analytical clinical trial will be carried out. In consultation prior to the therapeutic procedure, data will be collected regarding sex, ag

D02.078.370.141.100

Eligibility

Age

30 Years to 65 Years

Inclusion criteria

Inclusion criteria: Normosystemic patients; of both sexes; aged between 30 and 65 years; oriented and cooperative; with autonomy to promote self-care regarding oral hygiene and with a mouthing and spitting reflex; presenting gingivitis and admitted to a ward

Exclusion criteria

Exclusion criteria: Confirmed history of allergy to Chloramine T 0.2% and Chlorhexidine 0.12% or components of formulas; pregnant or breastfeeding women; presence of infections in the oral cavity; patients with impaired self-care; individuals with a history of adverse reactions to chlorhexidine or components of the formula; patients/guardians who did not sign the free and informed consent form

Design outcomes

Primary

Measure	Time frame
The primary outcome will be the assessment of the effectiveness of the substances tested in reduction of gingival inflammation in hospitalized patients. To evaluate the reduction of gingival inflammation, the Löe Gingival Index will be performed with a periodontal probe for PSR (Golgran) in four sites per tooth, these being: mesio-buccal, mesio-lingual, disto-buccal and disto-lingual. The sum of these values divided by four (number of sites) will result in the gingival index for the evaluated tooth. The sum of the gingival indices of each tooth, divided by the number of teeth examined, will result in the index per patient. This assessment will take place immediately before starting administration of the solutions and will be repeated every five days from the start of treatment, totaling fifteen days of administration of the solutions and four assessments. The results of the Löe Gingival Index will be computed in individual clinical records.	—

Measure

Time frame

The primary outcome will be the assessment of the effectiveness of the substances tested in reduction of gingival inflammation in hospitalized patients. To evaluate the reduction of gingival inflammation, the Löe Gingival Index will be performed with a periodontal probe for PSR (Golgran) in four sites per tooth, these being: mesio-buccal, mesio-lingual, disto-buccal and disto-lingual. The sum of these values divided by four (number of sites) will result in the gingival index for the evaluated tooth. The sum of the gingival indices of each tooth, divided by the number of teeth examined, will result in the index per patient. This assessment will take place immediately before starting administration of the solutions and will be repeated every five days from the start of treatment, totaling fifteen days of administration of the solutions and four assessments. The results of the Löe Gingival Index will be computed in individual clinical records.

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Secondary

Measure	Time frame
Não são esperados desfechos secundários.	—

Countries

Brazil

Contacts

Public ContactYlana Matos

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

ylanarm@gmail.com+55(85)31014151

Outcome results

None listed

Source: REBEC (via WHO ICTRP)