HalitosisNCT03031756
Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis
A study testing glycine powder air-polishing (Air-Flows)Perio Powder and ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) in people with Halitosis, run by Near East University, Turkey.
Trial summary
The aim of this clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis. Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Read more about this study
- Who is it for?
- Ages 28 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- glycine powder air-polishing (Air-Flows)Perio Powder and ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Apr 2016
- 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 28 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In the present trial, patients who had at least three teeth with 4-6-mm periodontal pockets.
Who cannot join
- acute infectious oral lesions,
- furcation defects,
- using antibiotics for any reason in the last 4 weeks,
- periodontal treatment in the last 6 months and
- pregnant or lactating patients.
About this study
Official title: Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis: A Randomized Clinical Study
The aim of this clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis.
Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately after treatment, and at 7 days, 14 days and 1 month.
- Conditions
- Halitosis
- Being tested
- glycine powder air-polishing (Air-Flows)Perio Powder, ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)
- Keywords
- Air polishing
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycine powder air-polishing (Air-Flows)Perio PowderDevice
Also called EMS, Nyon
ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)Device
Also called EMS Piezon Master
| Study group | Role | What they receive |
|---|---|---|
| test | Experimental | SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation, glycine powder air-polishing (GPAP) was performed for 10 seconds per surface after the instrumentation (Air-Flows Perio Powder, EMS, Nyon, Switzerland) was applied using a Perio-Flows hand-piece connected to an airflow unit (Air-Flow Masters, EMS). Receives: Device: glycine powder air-polishing (Air-Flows)Perio Powder; Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) |
| control | Active comparator | In the control group, SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation. Receives: Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) |
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 posted26 Jan 2017 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionApr 2016
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
- 60 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
- NCT03031756
- Sponsor's protocol ID
- 33-236-2015
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 26 Jan 2017
- 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 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03031756
- Acronym / sponsor ID
- 33-236-2015
- Conditions
- Halitosis
- Keywords
- Air polishing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 clinical study was to evaluate the clinical efficacy of using perio flow adjunctively with mechanical instrumentation on periodontal parameters and halitosis.
Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur compound (VSC) values were measured by a halimeter at the baseline, immediately after treatment, and at 7 days, 14 days and 1 month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test | Experimental | Device: glycine powder air-polishing (Air-Flows)Perio Powder, Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation, glycine powder air-polishing (GPAP) was performed for 10 seconds per surface after the instrumentation (Air-Flows Perio Powder, EMS, Nyon, Switzerland) was applied using a Perio-Flows hand-piece connected to an airflow unit (Air-Flow Masters, EMS). |
| control | Active comparator | Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)In the control group, SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation. |
Who may qualify
- Ages
- 28 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In the present trial, patients who had at least three teeth with 4-6-mm periodontal pockets.
Key exclusion criteria (5 listed)
- acute infectious oral lesions,
- furcation defects,
- using antibiotics for any reason in the last 4 weeks,
- periodontal treatment in the last 6 months and
- pregnant or lactating patients.
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 |
|---|---|---|
| glycine powder air-polishing (Air-Flows)Perio PowderAlso: EMS, Nyon | Device | test |
| ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)Also: EMS Piezon Master | Device | control, test |
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 26 Jan 2017.
- 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 glycine powder air-polishing (Air-Flows)Perio Powder and ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) 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 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 26 Jan 2017. 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 26 Jan 2017.