GingivitisNCT04733196
Clinical Effectiveness of 5 Different Mouthwashes in the Treatment of Generalised Gingivitis
A study testing Essential oils, Essential oils in combination with chlorhexidine 0,12% and Chlorhexidine 0,20 % in combination with aroma oils in people with Gingivitis, run by Plovdiv Medical University at 1 site in Bulgaria.
Trial summary
The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Essential oils, Essential oils in combination with chlorhexidine 0,12% and Chlorhexidine 0,20 % in combination with aroma oils
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Oct 2020to 20 Dec 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Plaque Index (Turesky, 1970) > 1,95;
- Gingival Index (Loe \& Silness, 1963) > 0,95;
- Bleeding Index (Animo \& Bay, 1975) > 30 %;
- no systemic diseases;
- no systemic medication.
Who cannot join
- severely destroyed teeth;
- crowns;
- non correct obturation class II and V;
- orthodontic treatment;
- third molars.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment
The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.
Read the detailed description
The present clinical study aims to investigate the clinical efficacy of 5 mouthwashes based on different active substances. The study include 180 patients divided into 6 groups of 30 patients, each group rinse with one of the following mouthwashes - mouthwash based on essential oils (menthol, thymol and eucalyptus), mouthwash based on essential oils (menthol, thymol and eucalyptus) and 0.12% chlorhexidine, mouthwash based on 0,8 % hydrogen peroxide, mouthwash based on prebiotic, water based on 0.2% chlorhexidine, placebo mouthwash. Inclusion criteria are: generalized gingival inflammation, plaque index of Turesky, 1970 > 1.95, gingival index of Loe \& Silness, 1963 > 0.95, no systemic diseases, no systemic medication, lack of severely damaged teeth, no large fillings, no orthodontic treatment. Patients are motivated and instructed to maintain proper and optimal personal oral hygiene. All participants undergo professional mechanical plaque removal. After instrumentation participants are instructed to rinse with 15 ml mouthwash 2 times a day for 21 days. Researchers control the amount of mouthwash used by giving a new bottle of mouthwash with the required amount for 1 patient for 1 week at the beginning of each week and taking back the bottle from the previous week. During the study period, patients are monitored on days 14 and 21, examining plaque index of Turesky, 1970, gingival index of Loe \& Silness, 1963, bleeding index of Ainamo \& Bay, 1975, side effects like staining, burning itching, oral lesions. At the end of the study (day 21), patients complete a questionnaire.
- Conditions
- Gingivitis
- Being tested
- Essential oils, Essential oils in combination with chlorhexidine 0,12%, Placebo mouthwash, Chlorhexidine 0,20 % in combination with aroma oils, Prebiotic
- Keywords
- Gingivitis, Mouthwashes, Essential oils, chlorhexidine gluconate, hydrogen peroxide, prebiotics, chlorhexidine
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential oilsDrug
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Essential oils in combination with chlorhexidine 0,12%Drug
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Placebo mouthwashDrug
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Chlorhexidine 0,20 % in combination with aroma oilsDrug
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
PrebioticDrug
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
Hydrogen peroxide 0,8 %Drug
Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Essential oils | Experimental | Mouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol Receives: Drug: Essential oils |
| Essential oils in combination with clorhexidine 0,12% | Experimental | Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine Receives: Drug: Essential oils in combination with chlorhexidine 0,12% |
| Placebo mouthwash | Placebo comparator | Water, colorant, sweetener Receives: Drug: Placebo mouthwash |
| Clorhexidine 0,20% in combination with aroma oils | Experimental | Mouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender Receives: Drug: Chlorhexidine 0,20 % in combination with aroma oils |
| Prebiotic | Experimental | Mouthwash based on prebiotic Receives: Drug: Prebiotic |
| Hydrogen peroxide | Experimental | Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil Receives: Drug: Hydrogen peroxide 0,8 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline bleeding index at 21 day.
Recording the bleeding index of Ainamo\&Bay, 1975. The index reports the presence or absence of bleeding on probing in 4 sites around every tooth. It is calculated in % for the whole dentition.
Measured: 21 days
Secondary outcomes (2)
Change from baseline gingival index at 21 day.
The gingival index of Loe, 1967 estimates the inflammation of the gingiva in 4 sites around every tooth, examining the colour, the texture, the consistency and the bleeding of the gingiva.
Measured: 21 days
Change from baseline oral hygiene index at 21 day.
The index of Turesky, 1970 is used. After discolouration of the plaque its distribution is measured in 6 sites of every tooth. The mean value is calculated by summing the individual values for each tooth and dividing the sum by all the places examined.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start1 Oct 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 180 participants are assigned to 6 groups. Each group of 30 participants with gingivitis rinse with one of the mouthwashes: based on prebiotic, hydrogen peroxide, essential oils, essential oils in combination with 0,12% chlorhexidine, 0,20% chlorhexidine for 3 weeks after mechanical plaque control.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plovdiv Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blagovesta Yaneva, Plovdiv Medical University
- Investigators
- Blagovesta Yaneva, PhD, Principal investigator, Plovdiv Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733196
- Sponsor's protocol ID
- PlovdivMU-mouthwash
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing the Clinical Effectiveness of 5 Mouthwashes Based on Essential Oils, Chlorhexidine, Hydrogen Peroxide and Prebiotic, in Gingivitis Treatment
- ClinicalTrials.gov ID
- NCT04733196
- Acronym / sponsor ID
- PlovdivMU-mouthwash
- Conditions
- Gingivitis
- Keywords
- Gingivitis, Mouthwashes, Essential oils, chlorhexidine gluconate, hydrogen peroxide, prebiotics, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Plovdiv Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 1 Feb 2021 (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.
The aim of the present study is to evaluate the efficacy of 5 mouthwashes, based on different ingredients, in the treatment of generalised gingivitis.
Detailed description
The present clinical study aims to investigate the clinical efficacy of 5 mouthwashes based on different active substances. The study include 180 patients divided into 6 groups of 30 patients, each group rinse with one of the following mouthwashes - mouthwash based on essential oils (menthol, thymol and eucalyptus), mouthwash based on essential oils (menthol, thymol and eucalyptus) and 0.12% chlorhexidine, mouthwash based on 0,8 % hydrogen peroxide, mouthwash based on prebiotic, water based on 0.2% chlorhexidine, placebo mouthwash. Inclusion criteria are: generalized gingival inflammation, plaque index of Turesky, 1970 > 1.95, gingival index of Loe \& Silness, 1963 > 0.95, no systemic diseases, no systemic medication, lack of severely damaged teeth, no large fillings, no orthodontic treatment. Patients are motivated and instructed to maintain proper and optimal personal oral hygiene. All participants undergo professional mechanical plaque removal. After instrumentation participants are instructed to rinse with 15 ml mouthwash 2 times a day for 21 days. Researchers control the amount of mouthwash used by giving a new bottle of mouthwash with the required amount for 1 patient for 1 week at the beginning of each week and taking back the bottle from the previous week. During the study period, patients are monitored on days 14 and 21, examining plaque index of Turesky, 1970, gingival index of Loe \& Silness, 1963, bleeding index of Ainamo \& Bay, 1975, side effects like staining, burning itching, oral lesions. At the end of the study (day 21), patients complete a questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
- Model description
- 180 participants are assigned to 6 groups. Each group of 30 participants with gingivitis rinse with one of the mouthwashes: based on prebiotic, hydrogen peroxide, essential oils, essential oils in combination with 0,12% chlorhexidine, 0,20% chlorhexidine for 3 weeks after mechanical plaque control.
| Arm | Type | Receives |
|---|---|---|
| Essential oils | Experimental | Drug: Essential oilsMouthwash based on essential oils - menthol, eucalypts oil, thymol, alcohol |
| Essential oils in combination with clorhexidine 0,12% | Experimental | Drug: Essential oils in combination with chlorhexidine 0,12%Mouthwash based on essential oils - mentol, eucalypt oil, thymol, alcohol, and 0,12% chlorhexidine |
| Placebo mouthwash | Placebo comparator | Drug: Placebo mouthwashWater, colorant, sweetener |
| Clorhexidine 0,20% in combination with aroma oils | Experimental | Drug: Chlorhexidine 0,20 % in combination with aroma oilsMouthwash based on 0,20% chorhexidine without alcohol in combination with aroma oils of rose and lavender |
| Prebiotic | Experimental | Drug: PrebioticMouthwash based on prebiotic |
| Hydrogen peroxide | Experimental | Drug: Hydrogen peroxide 0,8 %Mouthwash based on 0,8% hydrogen peroxide in combination with menthol and eucalypts oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Plaque Index (Turesky, 1970) > 1,95;
- Gingival Index (Loe \& Silness, 1963) > 0,95;
- Bleeding Index (Animo \& Bay, 1975) > 30 %;
- no systemic diseases;
- no systemic medication.
Key exclusion criteria (5 listed)
- severely destroyed teeth;
- crowns;
- non correct obturation class II and V;
- orthodontic treatment;
- third molars.
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 |
|---|---|---|
| Essential oilsParticipants were asked to rinse with 15 ml mouthwash twice daily for 21 days. | Drug | Essential oils |
| Essential oils in combination with chlorhexidine 0,12%Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. | Drug | Essential oils in combination with clorhexidine 0,12% |
| Placebo mouthwashParticipants were asked to rinse with 15 ml mouthwash twice daily for 21 days. | Drug | Placebo mouthwash |
| Chlorhexidine 0,20 % in combination with aroma oilsParticipants were asked to rinse with 15 ml mouthwash twice daily for 21 days. | Drug | Clorhexidine 0,20% in combination with aroma oils |
| PrebioticParticipants were asked to rinse with 15 ml mouthwash twice daily for 21 days. | Drug | Prebiotic |
| Hydrogen peroxide 0,8 %Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days. | Drug | Hydrogen peroxide |
Primary outcome
Change from baseline bleeding index at 21 day.
Time frame: 21 days
Recording the bleeding index of Ainamo\&Bay, 1975. The index reports the presence or absence of bleeding on probing in 4 sites around every tooth. It is calculated in % for the whole dentition.
2 secondary outcomes
Change from baseline gingival index at 21 day.
Time frame: 21 days
Change from baseline oral hygiene index at 21 day.
Time frame: 21 days
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 1 Feb 2021.
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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.
Blagovesta Yaneva, PhD principal investigator
Plovdiv Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential oils, Essential oils in combination with chlorhexidine 0,12% and Chlorhexidine 0,20 % in combination with aroma oils in people with Gingivitis, run by Plovdiv Medical University at 1 site in Bulgaria.
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 5 inclusion and 5 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 1 Feb 2021. 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 Bulgaria. 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. Some participants in this study may receive a placebo. 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?
Change from baseline bleeding index at 21 day. (time frame: 21 days). 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 1 Feb 2021.