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Effect of a dental floss impregnated with chlorhexidine in adults with Gingivitis

Efficacy of a dental floss impregnated with chlorhexidine in adults individuals with gingivitis: a randomized controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-7nx3kwp
Enrollment
Unknown
Registered
2022-08-02
Start date
2022-02-18
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

The presence of gingivitis will be evaluated in three groups described below in patients who will or will not receive intervention with flossing and chlorhexidine impregnation: Negative control group
14 patients who will not perform any type of interproximal cleaning
Positive control group (PC): with intervention
14 patients who will use, twice a day, an unwaxed dental floss without any impregnation
Test group (T): with intervention and substance use
14 patients who will use the same dental floss, however, with 2% chlorhexidine digluconate impregnation, also twice a day. For all groups, the study time will be 42 days.

Sponsors

Universidade Federal de Pelotas
Lead Sponsor
Universidade Federal do Rio Grande do Sul
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women at least 18 years of age; avaliable to participate in all phases of the study; good general systemic health; have at least 20 natural teeth present, with the exception of third molars; contiguous interproximal spaces with indication for flossing; have a diagnosis of biofilm-induced gingivitis, with the presence of bleeding gingival in at least 10 percent of the sites examined; being right-handed

Exclusion criteria

Exclusion criteria: Individuals with moderate periodontitis according to the criteria Eke et al 2012, defined as at least two interproximal sites with attachment loss of at least 4mm not on the same tooth or at least two interproximal sites with a depth of probing of at least 5mm not in the same tooth; individuals with severe periodontitis according to the criteria of Eke et al. 2012, defined as at least one interproximal site with probing depth of at least 5 mm and at least 6 mm attachment loss, in at least two interproximal sites, indistinct teeth; individuals who smoke or who have quit smoking for less than one year; individuals with the presence of biofilm retentive factors, except calculus supragingival; those who used systemic antibiotics in the three months prior to the carrying out the study; carriers of any systemic changes, such as diabetes and hormonal disorders with periodontal repercussions; individuals who need to use antimicrobial chemoprophylaxis to receive dental treatment; have undergone periodontal treatment in the last six months; have used chlorhexidine in the last three months; pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
The primary outcome of the present study will be a reduction in the rate of marginal bleeding this event will occur from the use of dental floss impregnated with 2% chlorhexidine and instructions and techniques for correct oral hygiene in addition to the removal of plaque retentive factors in the initial consultation.

Secondary

MeasureTime frame
The other variables collected, plaque index, presence of supragingival calculus, dental staining index, and bleeding on probing, will be considered secondary outcomes. This data will be collected at the initial consultation, 4 and 6 weeks after using the products in order to determine their effectiveness.

Countries

Brazil

Contacts

Public ContactFrancisco Wilker Muniz

Universidade Federal de Pelotas

wilkermustafa@gmail.com+55(53)3222-2766

Outcome results

None listed

Source: REBEC (via WHO ICTRP)