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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03468595
Other study ID # EK-2012-9-51
Secondary ID
Status Completed
Phase N/A
First received March 9, 2018
Last updated March 15, 2018
Start date March 2016
Est. completion date May 2017

Study information

Verified date March 2018
Source Near East University, Turkey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 2017
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasonic (Piezon Master 700) performed with Listerine

ultrasonic (Piezon Master 700) performed with CHX

ultrasonic (Piezon Master 700) performed with serum


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Near East University, Turkey

Outcome

Type Measure Description Time frame Safety issue
Primary 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 halimeter values 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. 30 day
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