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NCT Number: NCT04032548

Effectiveness of Propolis Mouthwash on Gingivitis

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shilpa

Jenjarum, Selangor, 42610, Malaysia

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Mouthwash

Drug

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

Other names: Mouthwash

Propolis mouthwash

Drug

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

Other names: Mouthwash

Chlorhexidine mouthwash

Drug

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

Other names: Mouthwash

Primary outcomes

  1. Change in Gingival Index (GI)

    Time frame: Difference for the mean gingival score from baseline to 21 days.

    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.

  2. Change in Plaque Index (PI)

    Time frame: Difference in the mean reduction of Plaque score from baseline to 21 days.

    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.

Sponsors and collaborators

Lead sponsor

Mahsa University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2019
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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