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Completed

NCT Number: NCT02756377

A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases

Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with gingivitis as compared to non-alcoholic chlorhexidine mouth wash.

Methods & Material: Twenty-four subjects, without systemic diseases, with plaque-induced gingivitis will be selected for this study. The patients were treated with scaling and root planing at the baseline; Oral hygiene instructions were given that included brushing twice- daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2 minutes, these patients were randomly ,equally divided into two groups, Group A: perform daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium, (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of each volunteer were measured.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

In this study, 34 patients referred to periodontics Department that no serious systemic disease in terms of periodontitis and disease Gingivitis (ie pockets of periodontal tissue to a depth of less than or equal to 4 mm without CAL in the jaw down or up) the following explanation necessary for the procedure tastings consent, the index of oral hygiene (plaque index) index # Turesky, pocket depth and to control the inflammatory condition * bleeding index bleeding during the probe based on Carter and Barnes (if any bleeding number 1 and its absence 0) and attachment loss were evaluated areas. The amount of pigment (Stain) after of using mouthwash based on S.I (Stain Index) was evaluated .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria: adult patients with gingivitis, older than 18 years old, systemically healthy, and having at least 20 teeth.

Exclusion criteria

patients with cavitated caries, no periodontal pockets larger than 4 mm, orthodontic appliances or removable prostheses, allergies to cetyl pyridinium or CHX, use of antibiotics and anti-inflammatory drugs in the past 3 months that might alter normal gingival health, oral prophylaxis outside of study; use of oral chlorhexidine products or participation in an oral rinse study within 3 months prior to baseline examination, pregnancy or nursing, smoking.

Study Population 34 eligibles were enrolled in the study, was designed as a Randomized, Double-blind clinical trials.

Treatment and study plan

Cetylpyridinium chloride mouthwash

Drug

cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Other names: control

Chlorhexidine mouthwash

Drug

Chlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Other names: Experimental Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

Primary outcomes

  1. Reduction of bleeding on probing

    Time frame: 7 days

    Periodontal pobe

Secondary outcomes

  1. Reduction of plaque index

    Time frame: 7 days

    Plaque Index (O'Leary)

  2. Reduction of pocket depth

    Time frame: 7days

    Periodontal pobe

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study title

A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases (A Randomized, Double-blind Clinical Trials)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2016
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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