Effectiveness of Propolis Mouthwash on Gingivitis

Comparison of Effectiveness of Propolis Mouthwash on Gingivitis - Randomized Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Placebo mouthwash; Drug: Propolis mouthwash; Drug: Chlorhexidine mouthwash

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)

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Jenjarum, Selangor, Malaysia, 42610
      • Shilpa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.	Drug: Placebo mouthwash; After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).; Other Names: Mouthwash
Experimental: Propolis; Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.	Drug: Propolis mouthwash; After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).; Other Names: Mouthwash
Active Comparator: Chlorhexidine; Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.	Drug: Chlorhexidine mouthwash; After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).; Other Names: Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Index (GI)	The primary outcome variable was the differences for the mean gingival score from baseline to 21 days. The gingival index ranges from 0-3 which is a continuous scale. '0' indicates normal healthy gingiva without inflammation (better score) ; and score '3' indicates severe gingival inflammation (worst score). The index teeth of each participant were examined and gingival status is scored. The score for each subject is added and divided by the total number of teeth examined. The average/mean gingival score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.	Difference for the mean gingival score from baseline to 21 days.
Change in Plaque Index (PI)	The primary outcome variable was the differences for the mean plaque score from baseline to 21 days. The plaque index ranges from 0-3 which is a continuous scale. '0' indicates no plaque on teeth (better score) ; and score '3' indicates abundance of plaque on the teeth (worst score). The index teeth of each participant were examined and plaque score is recorded. The score for each subject is added and divided by the total number of teeth examined. The average/mean plaque score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.	Difference in the mean reduction of Plaque score from baseline to 21 days.

Collaborators and Investigators

• Sponsor: Mahsa University
• Investigators: Principal Investigator: Shilpa Gunjal, Ph.D, Mahsa University

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): March 11, 2019
• Study Completion (Actual): June 5, 2019

Study Registration Dates

• First Submitted: July 23, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 27, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine; Propolis
• Other Study ID Numbers: RP104-10/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No