search
Back to results

Effectiveness of Propolis Mouthwash on Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Placebo mouthwash
Propolis mouthwash
Chlorhexidine mouthwash
Sponsored by
Mahsa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Shilpa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

Propolis

Chlorhexidine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2019
Last Updated
July 27, 2019
Sponsor
Mahsa University
search

1. Study Identification

Unique Protocol Identification Number
NCT04032548
Brief Title
Effectiveness of Propolis Mouthwash on Gingivitis
Official Title
Comparison of Effectiveness of Propolis Mouthwash on Gingivitis - Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
March 11, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahsa University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.
Arm Title
Propolis
Arm Type
Experimental
Arm Description
Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
Subjects were asked to rinse 10 ml of mouthwash twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Placebo mouthwash
Other Intervention Name(s)
Mouthwash
Intervention Description
After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
Intervention Type
Drug
Intervention Name(s)
Propolis mouthwash
Other Intervention Name(s)
Mouthwash
Intervention Description
After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
Mouthwash
Intervention Description
After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
Primary Outcome Measure Information:
Title
Change in Gingival Index (GI)
Description
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.
Time Frame
Difference for the mean gingival score from baseline to 21 days.
Title
Change in Plaque Index (PI)
Description
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.
Time Frame
Difference in the mean reduction of Plaque score from baseline to 21 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shilpa Gunjal, Ph.D
Organizational Affiliation
Mahsa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shilpa
City
Jenjarum
State/Province
Selangor
ZIP/Postal Code
42610
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Propolis Mouthwash on Gingivitis

We'll reach out to this number within 24 hrs