Clinical trial NCT04032548: Effectiveness of Propolis Mouthwash on Gingivitis
Official title: Comparison of Effectiveness of Propolis Mouthwash on Gingivitis - Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: Mahsa University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Gingival Index (GI)
timeFrame: Difference for the mean gingival score from baseline to 21 days.
measure: Change in Plaque Index (PI)
timeFrame: Difference in the mean reduction of Plaque score from baseline to 21 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Jenjarum
country: Malaysia
facility: Shilpa
state: Selangor
Study officials:
affiliation: Mahsa University
name: Shilpa Gunjal, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: