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Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis

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ClinicalTrials.gov Identifier: NCT03468595
Recruitment Status : Completed
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hasan Guney YILMAZ, Near East University, Turkey

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Halitosis Device: ultrasonic (Piezon Master 700) performed with Listerine Device: ultrasonic (Piezon Master 700) performed with CHX Device: ultrasonic (Piezon Master 700) performed with serum Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bad Breath
Drug Information available for: Listerine

Arm Intervention/treatment
Experimental: test 1
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.
Device: ultrasonic (Piezon Master 700) performed with CHX
Other Name: EMS, Nyon

Experimental: test 2
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.
Device: ultrasonic (Piezon Master 700) performed with Listerine
Other Name: EMS, Nyon

Active Comparator: control
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.
Device: ultrasonic (Piezon Master 700) performed with serum
Other Name: EMS, Nyon




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. halimeter values [ Time Frame: 30 day ]
    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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In the present trial, who had periodontitis from patients undergoing periodontal treatment at the Department of Periodontology of our institution

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468595


Sponsors and Collaborators
Near East University, Turkey
Investigators
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Study Director: Hasan Guney YILMAZ, DDS, PhD Near East University, Faculty of Dentistry

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Responsible Party: Hasan Guney YILMAZ, Prof Dr, Near East University, Turkey
ClinicalTrials.gov Identifier: NCT03468595     History of Changes
Other Study ID Numbers: EK-2012-9-51
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hasan Guney YILMAZ, Near East University, Turkey:
Listerine, CHX

Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs