Effectiveness of Propolis Mouthwash on Gingivitis

NCT04032548 | Completed DMC

• 1 other identifier: RP104-10/16
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo mouthwash

Propolis

EXPERIMENTAL

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

Drug: Propolis mouthwash

Chlorhexidine

ACTIVE COMPARATOR

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

Drug: Chlorhexidine mouthwash

Interventions

Placebo mouthwash DRUG

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

Also known as: Mouthwash

Placebo

Propolis mouthwash DRUG

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

Also known as: Mouthwash

Propolis

Chlorhexidine mouthwash DRUG

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

Also known as: Mouthwash

Chlorhexidine

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahsa University: lead

Study Sites (1)

Shilpa

Jenjarum, Selangor, 42610, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 38582863 DERIVED

MeSH Terms

Conditions

Gingivitis

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Shilpa Gunjal, Ph.D

  Mahsa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: February 18, 2019
• Primary Completion: March 11, 2019
• Study Completion: June 5, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)