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

NCT ID: NCT03468595

Last Updated: 2018-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-05-31

Brief Summary

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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

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Conditions

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Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

ultrasonic (Piezon Master 700) performed with CHX

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

ultrasonic (Piezon Master 700) performed with Listerine

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

ultrasonic (Piezon Master 700) performed with serum

Intervention Type DEVICE

Interventions

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ultrasonic (Piezon Master 700) performed with Listerine

Intervention Type DEVICE

ultrasonic (Piezon Master 700) performed with CHX

Intervention Type DEVICE

ultrasonic (Piezon Master 700) performed with serum

Intervention Type DEVICE

Other Intervention Names

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EMS, Nyon EMS, Nyon EMS, Nyon

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Near East University, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Hasan Guney YILMAZ

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hasan Guney YILMAZ, DDS, PhD

Role: STUDY_DIRECTOR

Near East University, Faculty of Dentistry

Other Identifiers

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EK-2012-9-51

Identifier Type: -

Identifier Source: org_study_id

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