Mouth and Tooth DiseaseshbD2NCT04946617
Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels
An observational study of Mouth and Tooth Diseases and Periodontal Diseases, run by Istanbul Medeniyet University.
Trial summary
Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly… Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Mouth and Tooth Diseases, Periodontal Diseases, Gingivitis
- What is being tested?
- undefined
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2021to 20 Dec 2021
- How long will I take part?
- 6 Months
- 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 25 to 40 years
- All sexes
- Adult
Study population: The sample size was calculated using (power of 80%). The present study included 40 patients per group (total of 120) to have a power >80%.
Who may be able to join
- systemically healthy,
- presence of ≥20 natural teeth,
- agreement to participate in the study .
Who cannot join
- known systemic illness,
- smoking habit,
- pregnancy/ lactation,
- long-term use of anti-inflammatory drugs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels
Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. Therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hBD2 and LL-37 in saliva.
Read the detailed description
Periodontal health continues with a balanced interaction of the oral microflora with the host defense line.
- Conditions
- Mouth and Tooth Diseases, Periodontal Diseases, Gingivitis
- Being tested
- undefined
- Keywords
- Periodontitis, Gingivitis, Mouthwashes
- Medical subject headings
- Stomatognathic Diseases, Periodontal Diseases, Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
undefinedDrug
Also called Mouthwash Product
Rinsing with mouthwashes
| Study group | Role | What they receive |
|---|---|---|
| H group | healthy periodontium, BOP at \20 % of the sites and no sites with probing depth (PD) [3 mm and clinical attachment level (CAL) [2 mm or alveolar bone loss (N = 20, 12 males, 8 females, mean age: 33.38 Receives: Drug: undefined | |
| G group | gingivitis, BOP at ≥20 % of the sites and no sites with PD and CAL [3 mm or bone loss (N = 20, 6 males, 14 females, mean age: 32.35); Receives: Drug: undefined | |
| CP group | chronic periodontitis, ≥4 teeth in each jaw with PD of ≥5 mm, CAL of C4 mm, BOP at [≥80 % of the proximal sites and radiographic evidence of interproximal bone loss Receives: Drug: undefined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of periodontal parametres changes
Incidence of Gingivitis
Measured: 6 Months
Rate of periodontal parametres changes
Incidence of Periodontitis
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start20 Jul 2021 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mouth and Tooth DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Cihan Yavuz, Istanbul Medeniyet University
- Investigators
- Mustafa C Yavuz, PhD, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946617
- Sponsor's protocol ID
- 9.2.2017-30
- Acronym
- hbD2
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Dyke TE. Pro-resolving mediators in the regulation of periodontal disease. Mol Aspects Med. 2017 Dec;58:21-36. doi: 10.1016/j.mam.2017.04.006. Epub 2017 May 18.
PubMed 28483532
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels
- ClinicalTrials.gov ID
- NCT04946617
- Acronym / sponsor ID
- hbD2 / 9.2.2017-30
- Conditions
- Mouth and Tooth Diseases, Periodontal Diseases, Gingivitis
- Keywords
- Periodontitis, Gingivitis, Mouthwashes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Dec 2021 (estimated)
- First posted
- 1 Jul 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.
Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. Therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hBD2 and LL-37 in saliva.
Detailed description
Periodontal health continues with a balanced interaction of the oral microflora with the host defense line.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H group | – | Drug: undefinedhealthy periodontium, BOP at \20 % of the sites and no sites with probing depth (PD) [3 mm and clinical attachment level (CAL) [2 mm or alveolar bone loss (N = 20, 12 males, 8 females, mean age: 33.38 |
| G group | – | Drug: undefinedgingivitis, BOP at ≥20 % of the sites and no sites with PD and CAL [3 mm or bone loss (N = 20, 6 males, 14 females, mean age: 32.35); |
| CP group | – | Drug: undefinedchronic periodontitis, ≥4 teeth in each jaw with PD of ≥5 mm, CAL of C4 mm, BOP at [≥80 % of the proximal sites and radiographic evidence of interproximal bone loss |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- The sample size was calculated using (power of 80%). The present study included 40 patients per group (total of 120) to have a power >80%.
Key inclusion criteria (3 listed)
- systemically healthy,
- presence of ≥20 natural teeth,
- agreement to participate in the study .
Key exclusion criteria (4 listed)
- known systemic illness,
- smoking habit,
- pregnancy/ lactation,
- long-term use of anti-inflammatory drugs.
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 |
|---|---|---|
| undefinedAlso: Mouthwash ProductRinsing with mouthwashes | Drug | CP group, G group, H group |
Primary outcome
Rate of periodontal parametres changes
Time frame: 6 Months
Incidence of Gingivitis
Rate of periodontal parametres changes
Time frame: 6 Months
Incidence of Periodontitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Background: PubMed 28483532Van Dyke TE. Pro-resolving mediators in the regulation of periodontal disease. Mol Aspects Med. 2017 Dec;58:21-36. doi: 10.1016/j.mam.2017.04.006. Epub 2017 May 18.
- Individual participant dataSharing planned: Undecided
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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.
Mustafa C Yavuz, PhD principal investigator
Istanbul Medeniyet University
Questions about this trial
What is this clinical trial studying?
An observational study of Mouth and Tooth Diseases and Periodontal Diseases, run by Istanbul Medeniyet University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa C Yavuz, PhD (+905056429856, muscyz111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of periodontal parametres changes (time frame: 6 Months). 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?
On the ClinicalTrials.gov record for NCT04946617, which also lists 1 linked publication.
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 Jul 2021.