GingivitisNCT06685419
Propolis Containing Chewing Gum and Gingivitis
An observational study of Gingivitis, run by naksaka at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Propolis containing gum
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2022to 20 Jun 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be selected from the patients who apply to Istanbul Medipol University for gingival treatment.
Who may be able to join
- Systemically healthy
- Has at least 20 teeth in his/her mouth.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Esenler, 34075
About this study
Official title: Effects of Natural Propolis Extract-Containing Chewing Gum on Dental Plaque Accumulation and Gingivitis
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.
Read the detailed description
Plaque is the primary etiological factor of periodontal diseases and as a result, inflammation of the gingiva can clinically lead to irreversible consequences such as bone and attachment loss and even tooth loss. Removing the plaque is the most important criterion in preventing inflammation. Plaque should be removed by brushing and the use of interface cleansing agents such as dental floss. However, it has been reported in studies that manually brushing teeth reduces plaque by 70%.
Propolis, which has anti-inflammatory effects, has been used for years in the treatment of infections and wound healing. Propolis has been used and studied in dental applications such as reduction of dentin sensitivity, prevention of dental caries, treatment of oral mucositis caused by chemotherapy, treatment of gingival diseases and replantation of avulsed teeth. Therefore, we hypothesized that daily pure propolis containing chewing gum can improve periodontal results in gingivitis patients by reducing plaque accumulation. The purpose of this double-blind, randomized, placebo-controlled trial was to evaluate the effectiveness of chewing gum containing pure propolis in addition to mechanical treatment.
This study was planned as a double-blind, parallel design, randomized-placebo-controlled study. The sample size was calculated minimum 24 with 80% power. Considering the possible drop-outs, our study will consist of two groups (test and placebo), each of which includes 30 participants. The test group will chew the gum containing propolis 5 times a day for 10 minutes. Participants in the placebo group will chew the placebo gum, prepared with the same color, appearance and consistency, 5 times a day for 10 minutes. Both groups will be asked to chew the gums for 3 weeks after meals (3 main meals - 2 snacks)
Baseline periodontal records including plaque index and gingival index of all participants will be taken and scaling and root planing will be performed. All periodontal treatments and measurements will be made by a single periodontologist. Periodontal measurements will be performed on 4 surfaces of all teeth (mesio-buccal, mid-buccal, disto-buccal, mid-lingual) using a Williams periodontal probe. Patients who are eligible to participate in the study will be assigned to the placebo or test group by the closed envelope method.
Plaque index, gingival index, temporomandibular joint pain, sensation change, taste change will be evaluated using the Visual Analogue Scale (VAS). All parameters will be evaluated 1 week, 2 weeks and 3 weeks after the procedure. The data recorded in the form will be analyzed.
- Conditions
- Gingivitis
- Being tested
- Propolis containing gum
- Keywords
- Propolis, Gingivitis, Oral health
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propolis containing gumOther
Patients with moderate gingivitis will be asked to use gum containing propolis 5 times a day for a total of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Propolis containing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Change in plaque index
Measured: 1 month
Gingival index
Change in plaque index
Measured: 1 month
Secondary outcomes (2)
Temporomandibular joint pain
Temporomandibular joint pain
Measured: 1 month
Changes in taste
Changes in taste
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start6 Apr 2022
- Primary completion30 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- naksaka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, naksaka, Istanbul Medipol University Hospital
- Investigators
- Nurcan Altas, Principal investigator, Istanbul Medipol Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685419
- Sponsor's protocol ID
- IstanbulMUH1
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Natural Propolis Extract-Containing Chewing Gum on Dental Plaque Accumulation and Gingivitis
- ClinicalTrials.gov ID
- NCT06685419
- Acronym / sponsor ID
- IstanbulMUH1
- Conditions
- Gingivitis
- Keywords
- Propolis, Gingivitis, Oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- naksakaUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Plaque is the primary etiological factor of periodontal diseases and as a result, inflammation of the gingiva can clinically lead to irreversible consequences such as bone and attachment loss and even tooth loss. Removing the plaque is the most important criterion in preventing inflammation. Plaque should be removed by brushing and the use of interface cleansing agents such as dental floss. However, it has been reported in studies that manually brushing teeth reduces plaque by 70%.
Propolis, which has anti-inflammatory effects, has been used for years in the treatment of infections and wound healing. Propolis has been used and studied in dental applications such as reduction of dentin sensitivity, prevention of dental caries, treatment of oral mucositis caused by chemotherapy, treatment of gingival diseases and replantation of avulsed teeth. Therefore, we hypothesized that daily pure propolis containing chewing gum can improve periodontal results in gingivitis patients by reducing plaque accumulation. The purpose of this double-blind, randomized, placebo-controlled trial was to evaluate the effectiveness of chewing gum containing pure propolis in addition to mechanical treatment.
This study was planned as a double-blind, parallel design, randomized-placebo-controlled study. The sample size was calculated minimum 24 with 80% power. Considering the possible drop-outs, our study will consist of two groups (test and placebo), each of which includes 30 participants. The test group will chew the gum containing propolis 5 times a day for 10 minutes. Participants in the placebo group will chew the placebo gum, prepared with the same color, appearance and consistency, 5 times a day for 10 minutes. Both groups will be asked to chew the gums for 3 weeks after meals (3 main meals - 2 snacks)
Baseline periodontal records including plaque index and gingival index of all participants will be taken and scaling and root planing will be performed. All periodontal treatments and measurements will be made by a single periodontologist. Periodontal measurements will be performed on 4 surfaces of all teeth (mesio-buccal, mid-buccal, disto-buccal, mid-lingual) using a Williams periodontal probe. Patients who are eligible to participate in the study will be assigned to the placebo or test group by the closed envelope method.
Plaque index, gingival index, temporomandibular joint pain, sensation change, taste change will be evaluated using the Visual Analogue Scale (VAS). All parameters will be evaluated 1 week, 2 weeks and 3 weeks after the procedure. The data recorded in the form will be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Propolis containing gumPropolis-containing gum will be used to reduce plaque index scores 5 times a day, after and between meals, for a total of 3 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be selected from the patients who apply to Istanbul Medipol University for gingival treatment.
Key inclusion criteria (2 listed)
- Systemically healthy
- Has at least 20 teeth in his/her mouth.
Key exclusion criteria (8 listed)
- Smokers
- ongoing orthodontic treatment
- Allergy to the honey and honey-bee products
- periodontal therapy in the last 6 months.
- Pregnancy and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propolis containing gumPatients with moderate gingivitis will be asked to use gum containing propolis 5 times a day for a total of 3 weeks. | Other | Test Group/Propolis-containing gum group |
Primary outcome
Plaque index
Time frame: 1 month
Change in plaque index
Gingival index
Time frame: 1 month
Change in plaque index
2 secondary outcomes
Temporomandibular joint pain
Time frame: 1 month
Changes in taste
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurcan Altas principal investigator
Istanbul Medipol Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis, run by naksaka at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.