Effectiveness of Propolis Mouthwash on Gingivitis

NCT ID: NCT04032548

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-06-05

Brief Summary

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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

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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)

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type DRUG

After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).

Propolis

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

Group Type EXPERIMENTAL

Propolis mouthwash

Intervention Type DRUG

After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).

Chlorhexidine

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type DRUG

After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).

Interventions

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Placebo mouthwash

After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).

Intervention Type DRUG

Propolis mouthwash

After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).

Intervention Type DRUG

Chlorhexidine mouthwash

After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).

Intervention Type DRUG

Other Intervention Names

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Mouthwash Mouthwash Mouthwash

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahsa University

OTHER

Sponsor Role lead

Responsible Party

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Shilpa Gunjal

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shilpa Gunjal, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mahsa University

Locations

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Shilpa

Jenjarum, Selangor, Malaysia

Site Status

Countries

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Malaysia

References

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Gunjal S, Pateel DGS. Comparative effectiveness of Propolis with chlorhexidine mouthwash on gingivitis - a randomized controlled clinical study. BMC Complement Med Ther. 2024 Apr 6;24(1):154. doi: 10.1186/s12906-024-04456-8.

Reference Type DERIVED
PMID: 38582863 (View on PubMed)

Other Identifiers

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RP104-10/16

Identifier Type: -

Identifier Source: org_study_id

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