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

NCT03468595 | Completed

• 1 other identifier: EK-2012-9-51
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Halitosis

Keywords

Listerine, CHX

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 (3)

test 1

EXPERIMENTAL

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

test 2

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

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

Interventions

ultrasonic (Piezon Master 700) performed with Listerine DEVICE

Also known as: EMS, Nyon

test 2

ultrasonic (Piezon Master 700) performed with CHX DEVICE

Also known as: EMS, Nyon

test 1

ultrasonic (Piezon Master 700) performed with serum DEVICE

Also known as: EMS, Nyon

control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Near East University, Turkey: lead

MeSH Terms

Conditions

Halitosis

Interventions

Ultrasonography; Emergency Treatment

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Therapeutics

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: Prof Dr

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 16, 2018
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: May 1, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share