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Efficacy of a Mouthwash Containing Propolis (PRO)

F

Federal University of Minas Gerais

Status and phase

Unknown
Phase 3

Conditions

Periodontitis
Inflammation
Plaque
Gingivitis

Treatments

Drug: Propolis
Drug: chlorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01750801
Propolis

Details and patient eligibility

About

Characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. A Phase I.

Full description

Chemical characterization of propolis by HPLC (High-performance liquid chromatography), antimicrobial testing against pathogens and cariogenic. Studies in vitro on anti-inflammatory activity, cytotoxicity tests of green propolis.

Enrollment

2 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age ranging from 18 to 60 years
  • minimum of 20 natural teeth
  • mean plaque index (PI)of at least 1.5
  • an average gingival index (GI), at least less than 1.0.

Exclusion criteria

  • Individuals with orthodontic appliances or removable dentures,
  • Individuals whit tumors of soft tissue or hard mouth, and advanced periodontal disease,
  • Indivuduals whit antibiotic therapy 2 weeks prior to study initiation, or with known hypersensitivity propolis are also excluded.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

2 participants in 2 patient groups

Propolis
Active Comparator group
Description:
alcohol-free mouthwash containing 5% green propolis (MGP 5%) on the control of plaque and gingivitis.
Treatment:
Drug: chlorhexidine
chlorhexidine
Active Comparator group
Description:
chlorhexidine used on the control of plaque and gingivitis.
Treatment:
Drug: Propolis

Trial contacts and locations

1

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Central trial contact

andre oliveira naufel de toledo 35893/MG

Data sourced from clinicaltrials.gov

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