NCT03031756

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 16, 2017

Last Update Submit

January 25, 2017

Conditions

Keywords

Air polishing

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 day.

Secondary Outcomes (1)

  • halimeter values.

    30 day.

Study Arms (2)

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).

Device: glycine powder air-polishing (Air-Flows)Perio PowderDevice: 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.

Device: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)

Interventions

Also known as: EMS Piezon Master
controltest

Eligibility Criteria

Age28 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the present trial, patients who had at least three teeth with 4-6-mm periodontal pockets.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Halitosis

Interventions

Emergency TreatmentUltrasonography

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hasan Guney YILMAZ, DDS,PhD

    Near East University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof Dr

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 26, 2017

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

April 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share