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Trial record 11 of 13 for:    eucalyptol

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

Tracking Information
First Submitted Date  ICMJE March 9, 2018
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date March 16, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis
Official Title  ICMJE 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
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE Halitosis
Intervention  ICMJE
  • Device: ultrasonic (Piezon Master 700) performed with Listerine
    Other Name: EMS, Nyon
  • Device: ultrasonic (Piezon Master 700) performed with CHX
    Other Name: EMS, Nyon
  • Device: ultrasonic (Piezon Master 700) performed with serum
    Other Name: EMS, Nyon
Study Arms  ICMJE
  • 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.
    Intervention: Device: ultrasonic (Piezon Master 700) performed with CHX
  • 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.
    Intervention: Device: ultrasonic (Piezon Master 700) performed with Listerine
  • 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.
    Intervention: Device: ultrasonic (Piezon Master 700) performed with serum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03468595
Other Study ID Numbers  ICMJE EK-2012-9-51
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hasan Guney YILMAZ, Near East University, Turkey
Study Sponsor  ICMJE Near East University, Turkey
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hasan Guney YILMAZ, DDS, PhD Near East University, Faculty of Dentistry
PRS Account Near East University, Turkey
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP