Effectiveness of a long-acting medicament for the treatment of gingival inflammation

Effect of a chlorhexidine controlled release system for plaque control and gingivitis - randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-85kywk3

Enrollment

Unknown

Registered

2021-10-08

Start date

2017-01-15

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

Pathological conditions, signs and symptoms

Interventions

1 Experimental Population and Study Design This randomized, blinded, controlled clinical study aims to compare the effects of a 0.6% chlorhexidine gel (n=40) to the effects of a 0.6% chlorhexidine: ß-

G02.211

D02.078.370.141.100

Eligibility

Age

12 Years to 17 Years

Inclusion criteria

Inclusion criteria: Patients under orthodontic treatment with clinical diagnosis of gingivitis; Treatment with fixed appliances without dental extraction for a minimum period of six months; Presence of allergic series on the components of the gels; antibiotic therapy within six months.

Exclusion criteria

Exclusion criteria: Preoperative periodontal treatment; Presence of acute periodontal smokers; pregnant women; Treatment with chlorhexidine 0.12% or other chemical agent; Presence of Candidiasis;

Design outcomes

Primary

Measure	Time frame
Decreased gingival bleeding rate after 15 days (Ainamo & Bay, 1975) assessed by clinical measurements performed with a Goldman Fox / Williams periodontal probe (Trinity®, Sao Paulo, Brazil) at the buccal, lingual, mesial, and distal tooth sites in each patient except incisors, canines and third molars.;Decreased plaque index after 15 days (Ainamo & Bay, 1975) assessed by clinical measurements performed with a Goldman Fox / Williams periodontal probe (Trinity®, Sao Paulo, Brazil) at the buccal, lingual, mesial, and distal tooth sites at each patient except incisors, canines and third molars.;Reduction in IL-1b levels 15 days after the end of the study evaluated by gingival crevicular fluid collection with filter paper strips inserted into the gingival sulcus and subsequently submitted to quantitative analysis of messenger RNA expression by real-time PCR	—

Measure

Time frame

Decreased gingival bleeding rate after 15 days (Ainamo & Bay, 1975) assessed by clinical measurements performed with a Goldman Fox / Williams periodontal probe (Trinity®, Sao Paulo, Brazil) at the buccal, lingual, mesial, and distal tooth sites in each patient except incisors, canines and third molars.;Decreased plaque index after 15 days (Ainamo & Bay, 1975) assessed by clinical measurements performed with a Goldman Fox / Williams periodontal probe (Trinity®, Sao Paulo, Brazil) at the buccal, lingual, mesial, and distal tooth sites at each patient except incisors, canines and third molars.;Reduction in IL-1b levels 15 days after the end of the study evaluated by gingival crevicular fluid collection with filter paper strips inserted into the gingival sulcus and subsequently submitted to quantitative analysis of messenger RNA expression by real-time PCR

—

Secondary

Measure	Time frame
we did not identify a secondary outcome	—

Countries

Brazil

Contacts

Public ContactEsdras França

esdrasodonto@gmail.com+5531988324880

Outcome results

None listed

Source: REBEC (via WHO ICTRP)