HalitosisNCT03468595
Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis
A study testing ultrasonic (Piezon Master 700) performed with Listerine, ultrasonic (Piezon Master 700) performed with CHX and ultrasonic (Piezon Master 700) performed with serum in people with Halitosis, run by Near East University, Turkey.
Trial summary
The aim of this trial was to establish the clinical efficacy of Listerine and chlorhexidine (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters and halitosis. Ninety patients with periodontal disease participated for the study. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- ultrasonic (Piezon Master 700) performed with Listerine, ultrasonic (Piezon Master 700) performed with CHX and ultrasonic (Piezon Master 700) performed with serum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2017
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In the present trial, who had periodontitis from patients undergoing periodontal treatment at the Department of Periodontology of our institution
Who cannot join
- Individuals who presented any systemic disorders which cause halitosis (diabetes mellitus, nephropathy, liver disease, gastrointestinal diseases, respiratory problems), pregnancy or lactation, individuals who had taken antibiotics over the last 6 months or permanently used any drugs, individuals who had any form of periodontal treatment within 6 months prior to the study.
About this study
Official title: Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis With Subgingival Ultrasonic Instrumentation in Periodontitis Patients: A Randomized Clinical Study
The aim of this trial was to establish the clinical efficacy of Listerine and chlorhexidine (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters and halitosis.
Ninety patients with periodontal disease participated for the study. Individuals were randomly selected to a control and test groups. At baseline, all subjects completed a questionnaire and carried out an examination. Standard periodontal outcome variables were assessed. For both groups, the plaque index (PI), gingival index (GI), pocket depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL) scores were enrolled at baseline and after 30 days. Volatile sulphur compound (VSC) levels were evaluated by a Halimeter (Interscan Corp., Chatsworth, CA, USA) at baseline (T0), immediately after treatment (T1), and at 7 (T2), 14 (T3) and 30 days (T4).
- Conditions
- Halitosis
- Being tested
- ultrasonic (Piezon Master 700) performed with Listerine, ultrasonic (Piezon Master 700) performed with CHX, ultrasonic (Piezon Master 700) performed with serum
- Keywords
- Listerine, CHX
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonic (Piezon Master 700) performed with ListerineDevice
Also called EMS, Nyon
ultrasonic (Piezon Master 700) performed with CHXDevice
Also called EMS, Nyon
ultrasonic (Piezon Master 700) performed with serumDevice
Also called EMS, Nyon
| Study group | Role | What they receive |
|---|---|---|
| test 1 | Experimental | The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with CHX (Drogsan, Istanbul, Turkey, 0.2%) was performed at one session for once. Receives: Device: ultrasonic (Piezon Master 700) performed with CHX |
| test 2 | Experimental | The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with Listerine (Johnson \& Johnson, Istanbul, Turkey, containing, 21.6% ethanol, 0.092% eucalyptol, 0.064% thymol, 0.042% menthol and 0.06% methyl salicylate) was performed at one session for once. Receives: Device: ultrasonic (Piezon Master 700) performed with Listerine |
| control | Active comparator | The treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with distilled water was performed at one session for once. Receives: Device: ultrasonic (Piezon Master 700) performed with serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Pocket Depth (PPD)
PD were evaluated: at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.
Measured: 30 day
Secondary outcomes (1)
halimeter values
The changes of Volatile Sulphure Compaunds by were evaluated with Halimeter Device at the follow-up sessions by the investigator. The Halimeter reads out in parts-per-billion (ppb) of volatile sulfur compounds.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startMar 2016
- Primary completionSep 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Guney YILMAZ, Near East University, Turkey
- Investigators
- Hasan Guney YILMAZ, DDS, PhD, Study director, Near East University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468595
- Sponsor's protocol ID
- EK-2012-9-51
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis With Subgingival Ultrasonic Instrumentation in Periodontitis Patients: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03468595
- Acronym / sponsor ID
- EK-2012-9-51
- Conditions
- Halitosis
- Keywords
- Listerine, CHX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Mar 2018 (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 this trial was to establish the clinical efficacy of Listerine and chlorhexidine (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters and halitosis.
Ninety patients with periodontal disease participated for the study. Individuals were randomly selected to a control and test groups. At baseline, all subjects completed a questionnaire and carried out an examination. Standard periodontal outcome variables were assessed. For both groups, the plaque index (PI), gingival index (GI), pocket depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL) scores were enrolled at baseline and after 30 days. Volatile sulphur compound (VSC) levels were evaluated by a Halimeter (Interscan Corp., Chatsworth, CA, USA) at baseline (T0), immediately after treatment (T1), and at 7 (T2), 14 (T3) and 30 days (T4).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| test 1 | Experimental | Device: ultrasonic (Piezon Master 700) performed with CHXThe treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with CHX (Drogsan, Istanbul, Turkey, 0.2%) was performed at one session for once. |
| test 2 | Experimental | Device: ultrasonic (Piezon Master 700) performed with ListerineThe treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with Listerine (Johnson \& Johnson, Istanbul, Turkey, containing, 21.6% ethanol, 0.092% eucalyptol, 0.064% thymol, 0.042% menthol and 0.06% methyl salicylate) was performed at one session for once. |
| control | Active comparator | Device: ultrasonic (Piezon Master 700) performed with serumThe treatment of periodontitis was performed with ultrasonic instrumentation (Piezonmaster 700; Electro Medical Systems, Nyon, Switzerland) with distilled water was performed at one session for once. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In the present trial, who had periodontitis from patients undergoing periodontal treatment at the Department of Periodontology of our institution
Key exclusion criteria (1 listed)
- Individuals who presented any systemic disorders which cause halitosis (diabetes mellitus, nephropathy, liver disease, gastrointestinal diseases, respiratory problems), pregnancy or lactation, individuals who had taken antibiotics over the last 6 months or permanently used any drugs, individuals who had any form of periodontal treatment within 6 months prior to the study.
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 |
|---|---|---|
| ultrasonic (Piezon Master 700) performed with ListerineAlso: EMS, Nyon | Device | test 2 |
| ultrasonic (Piezon Master 700) performed with CHXAlso: EMS, Nyon | Device | test 1 |
| ultrasonic (Piezon Master 700) performed with serumAlso: EMS, Nyon | Device | control |
Primary outcome
Periodontal Pocket Depth (PPD)
Time frame: 30 day
PD were evaluated: at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.
1 secondary outcome
halimeter values
Time frame: 30 day
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 16 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Hasan Guney YILMAZ, DDS, PhD study director
Near East University, Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonic (Piezon Master 700) performed with Listerine, ultrasonic (Piezon Master 700) performed with CHX and ultrasonic (Piezon Master 700) performed with serum in people with Halitosis, run by Near East University, Turkey.
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 1 inclusion and 1 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 16 Mar 2018. 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?
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?
Periodontal Pocket Depth (PPD) (time frame: 30 day). 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 16 Mar 2018.