Effectiveness of Propolis Mouthwash on Gingivitis

Mahsa University

Status: Completed

Conditions: Gingivitis

Treatments: Drug: Chlorhexidine mouthwash; Drug: Propolis mouthwash; Drug: Placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT04032548

RP104-10/16

Details and patient eligibility

About

Mouthrinses have been in used for centuries as breath fresheners, medicaments, and antiseptics. Recently, propolis has caught the eyes of dentists worldwide and researches are being carried out to infuse the usage of propolis in the dental health care treatments. There is belief that propolis may have a role as a tooth decay prophylaxis and help heal oral ulcers. Propolis is used as mouthwash, toothpaste, oral gel, and throat lozenges because of its proclaimed antibacterial and anti-inflammatory properties. Propolis has shown activity against common periodontal microorganisms, such as Candida species and the Streptococci mutans in vitro studies. Till date, no study has evaluated the clinical and microbiological effects of Malaysian Propolis as a mouthwash. Thus, the present study is designed to evaluate the effectiveness of Propolis as a mouthwash in the reduction of Plaque and gingivitis.The aim of the study is to assess and compare the effectiveness of Propolis mouthrinse with Chlorhexidine mouthrinse.

Full description

The Randomized Controlled Clinical study with latin-square cross-over design would be used to assess and compare the effectiveness of Propolis and Chlorhexidine mouthrinse on gingivitis. Subjects with chronic generalized gingivitis with age group of 18-30 years will be selected for the study as the target population. Subjects who meet the inclusion and exclusion criteria will be selected and screened for the plaque and gingival status before including them in the study. They will be randomly divided into three groups.

Group 1: 15 subjects (Placebo mouthwash) Group 2: 15 subjects (Propolis mouthwash) Group 3: 15 subjects (Chlorhexidine mouthwash)

Enrollment: 45 patients

Sex: All

Ages: 20 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gingival index >1
• Periodontal pocket depth ≤ 3 mm
• Clinical attachment loss "0"
• Provision of written informed consent
• Good systemic health.

Exclusion criteria

• Severe periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession
• Any condition that requires antibiotic premedication for the administration of a dental prophylaxis.
• Self-reported pregnancy, intent to become pregnant during the study, or breast-feeding.
• Any diseases or condition that could be expected to interfere with the safe completion of the study.
• History of antibiotic use in the previous 3 months.
• Individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.

Treatment:

Drug: Placebo mouthwash

Propolis

Experimental group

Description:

Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.

Treatment:

Drug: Propolis mouthwash

Chlorhexidine

Active Comparator group

Description:

Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.

Treatment:

Drug: Chlorhexidine mouthwash