NCT06685419

Brief Summary

Propolis is a natural, non-toxic, sticky substance produced by honeybees that can kill bacteria, fungi, and larvae invading the beehive. It has been used in the treatment of infections and healing of wounds and burns for years. This study evaluated the effects of chewing gum containing pure propolis on plaque accumulation and gum disease in patients who brushed their teeth regularly.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

2.2 years

First QC Date

November 11, 2024

Last Update Submit

November 11, 2024

Conditions

Keywords

PropolisGingivitisOral health

Outcome Measures

Primary Outcomes (2)

  • Plaque index

    Change in plaque index

    1 month

  • Gingival index

    Change in plaque index

    1 month

Secondary Outcomes (2)

  • Temporomandibular joint pain

    1 month

  • Changes in taste

    1 month

Study Arms (2)

Control Group

Placebo gum will be used to reduce plaque index scores 5 times a day, after and between meals, for a total of 3 weeks.

Test Group/Propolis-containing gum group

Propolis-containing gum will be used to reduce plaque index scores 5 times a day, after and between meals, for a total of 3 weeks.

Other: Propolis containing gum

Interventions

Patients with moderate gingivitis will be asked to use gum containing propolis 5 times a day for a total of 3 weeks.

Test Group/Propolis-containing gum group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants will be selected from the patients who apply to Istanbul Medipol University for gingival treatment.

You may qualify if:

  • Systemically healthy
  • Has at least 20 teeth in his/her mouth.

You may not qualify if:

  • Smokers
  • ongoing orthodontic treatment
  • Allergy to the honey and honey-bee products
  • periodontal therapy in the last 6 months.
  • Pregnancy and breastfeeding
  • Use of antibiotics or another drugs in the last three months,
  • Presence of subgingival caries or infection that will affect brushing
  • Patients who were not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Esenler, 34075, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Nurcan Altas

    Istanbul Medipol Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 12, 2024

Study Start

April 6, 2022

Primary Completion

May 30, 2024

Study Completion

June 20, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations